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Oncology: Clinical Studies Open For Enrollment

 

 

 

Lymphoma

 

 

Immunochemotherapy with Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in CAYA with recurrent refractory CD20+ Mature B-NHL

Eligibility

  • Subject is between three years and 31 years of age
  • In first or second relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02393157

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Safety and tolerability of myeloablative conditioning and autologous stem cell transplantation followed by Polatuzumab Vedotin (PV) immunoconjugate therapy in patients with B-cell non-Hodgkin and Hodgkin lymphoma

Enrollment Status: Enrolling

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between one month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure from Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults with Lymphoma (RADICAL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05253495

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (003)

Eligibility

  • Subject is at least 18 years of age
  • Relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least one line of prior therapy
  • Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least two lines of prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05139017

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANHL1931, A Randomized Phase 3 trial of Nivolumab (NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Eligibility

  • Subject is at least two years of age
  • Primary mediastinal B-cell lymphoma (PMBCL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04759586

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACCL1931: A Randomized Trial of Levocarnitine Prophylaxis to Prevent Asparaginase-Associated Hepatotoxicity in Adolescents and Young Adults Receiving Acute Lymphoblastic Leukemia Therapy

Eligibility

  • Male or female at least 15 years of age
  • Newly Diagnosed B-ALL, T-ALL, Lymphoblastic Lymphoma (LLy), or Mixed-Phenotype Acute Leukemia/Lymphoma (MPAL)

Enrollment Status: Enrolling

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

lauren_harrison@nymc.edu

 

A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab plus Lenalidomide compared to Rituximab plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Eligibility

  • Male and female, Subjects must be at least 18 years old
  • Subject is willing and able to comply with procedures required in this protocol
  • Subject must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug
  • Subjects must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care). Investigator's discretion should be applied
  • Subject must have available adequate fresh or paraffin-embedded tissue at Screening
  • Subject must have histologically confirmed CD20+ DLBCL and documented in the most recent representative pathology report, inclusive of the following according to the 5th edition of the WHO (2022) Classification of Haematolymphoid Tumours: Lymphoid Neoplasms
  • Subject must have R/R disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis
  • Subject must have an ECOG performance status score of 0 to 2
  • Life expectancy > 3 months on SOC treatment at the time of enrolling in the study
  • Exclusion Criteria
    • Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx
    • Lenalidomide exposure within 12 months prior to screening or history of documented refractoriness to lenalidomide with refractoriness
    • Best response to prior CAR-T therapy of SD or PD. Subject should not have received any treatment with CAR-T therapy within 90 days prior to randomization; any CAR-T related toxicity should have been resolved for at least 30 days
    • Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening
    • Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

Enrollment Status: Actively enrolling

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Leukemia

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML1831 CIRB, A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Eligibility

  • Subject is no older than 22 years of age
  • Newly diagnosed with de novo AML with or without extramedullary disease
  • Patient must have one of the following:
    • At least 20% bone marrow blasts (obtained within 14 days prior to enrollment)
    • Less than 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04293562

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1631, International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

Eligibility

  • Subject is between two and 21 years of age
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03007147

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML18P1, Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Eligibility

  • Subject is no older than 25 years of age
  • CML-CP at original diagnosis
  • Molecular remission (MR) with a BCR-ABL1 level of no more than 0.01% BCR-ABL1

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03817398

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Eligibility

  • Subject is 30 years of age or younger
  • Recurrent or refractory Hodgkin or non-Hodgkin Lymphoma and have failed at least one line or prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05255601

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ASCT2031, A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLAHaploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Eligibility

  • Subject is 6 months to 21 years of age
  • Diagnosed with ALL, AML or MDS and no sibling donor  
  • Has not received a prior allogeneic hematopoietic stem cell transplant

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05457556

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A PHASE 1/2 SAFETY, DOSE-FINDING, AND PHARMACOKINETICS STUDY OF VNX-101 GENE THERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY CD19+ B CELL ACUTE LYMPHOBLASTIC LEUKEMIA

Eligibility

  • Relapsed B cell ALL with BM blasts ≥5%
  • Refractory B cell ALL as defined by at least one of the following criteria:
    • Subjects who have failed to achieve a bone marrow CR after at least two prior lines of frontline therapy with curative intent (refractory disease; including persistent, positive MRD by flow cytometry >0.01%)
    • Subjects previously in remission who have failed to achieve a CR after at least 1 cycle of standard chemotherapy for relapsed leukemia (including persistent, positive MRD by flow cytometry >0.01%)
    • Subjects with Ph+ ALL who are intolerant of or have failed 3 lines of TKI therapy, or if TKI therapy is contraindicated
  • Leukemia blasts in bone marrow are CD19+ as determined by standard flow cytometry on samples obtained within up to 28 days of VNX-101 dosing
  • Part 1: Bone marrow blasts >0.01% to <5% by flow cytometry prior to VNX-101 dosing (a priori or post cytoreductive therapy). Part 2: Bone marrow blasts >0.01% to <50% by flow cytometry prior to VNX-101 dosing (a priori or post cytoreductive therapy)
  • Age
    • Part 1: ≥18 and ≤90 years at time of informed consent
    • Part 2: ≥13 and ≤90 years at time of informed consent
  • Ineligible for or declined to receive, or failed to respond to, FDA-approved CD19-directed CAR-T cell therapies based on the indications and contraindications for use of tisagenlecleucel (KYMRIAH®) and brexucabtagene autoleucel (TECARTUS®) as specified in their respective labeling; or declined to receive FDA-approved CD19-directed CAR-T cell therapies; or have already received and failed to respond to or relapsed after response to an FDA-approved CD19-directed CAR-T cell therapy
  • Absolute T cell count >200/mm3 within 3 days prior to VNX-101 dosing
  • Lansky >50% (<16 years) / ECOG performance status <3 (≥16 years)
  • Life expectancy >3 months
  • Exclusion criteria:
    • Subjects at high risk for AEs of special interest:
      • Hepatotoxicity: AST or ALT >2 × ULN
      • TMA: Prior history of TMA or HUS
      • Cardiomyopathy: History of inflammatory-mediated cardiomyopathy even if resolved, history of chemotherapy-induced cardiomyopathy requiring cardiac-directed therapies, and/or EF<40%
      • Dorsal root ganglion neuropathy: Evidence of sensory neuropathy (numbness, pain, proprioceptive loss, loss of deep tendon reflexes) not attributable to prior vinca alkaloid therapy
    • Infection or any other severe systemic disease, medical, surgical, or other condition that, in the Investigator’s opinion, could adversely affect the safety of the subject, interfere with the subject’s compliance with the protocol, or impair the assessment and interpretation of study results.
    • Administration of any unlicensed or investigational product within 5 half-lives prior to VNX-101 dosing.
    • Sexually active males and WOCBP unable to commit to highly effective contraception for the duration of the study and 60 months post VNX-101
    • Pregnant or nursing (lactating) women
    • Active or latent hepatitis B or active hepatitis C (tested within 8 weeks of screening or during screening), or any uncontrolled infection at screening
    • HIV positive test within 8 weeks of screening or during screening
    • Allogeneic HSCT within 3 months of VNX-101 dosing
    • Subjects with acute GvHD Grade 2-4 or chronic GvHD of any grade
    • Severe obesity: BMI >40. For subjects with BMI >30, the VNX-101 dose will be calculated based on an alternative body weight determination that assumes a maximum permissible BMI of 30 kg/m2. For example, a subject who is 6 feet 2 inches and weighs 168 kg (BMI 47.5) would receive a VNX-101 dose based on an alternative body weight of 106 kg (which is the body weight associated with a BMI of 30 for an individual who is 6 feet 2 inches tall).

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT06533579

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Solid Tumors


A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between 1 year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

Eligibility

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT)
  • Standard risk 1: Patient must be less than 11 years of age at enrollment
  • Standard risk 2: Patients must be at least 11 and less than 25 years of age at enrollment
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher)
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma; tumor markers: alpha-FP less than or equal to 1,000 ng/mL, beta-HCG institutional normal; all ages
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age less than 11 years
  • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP less than 1,000 ng/mL, beta-HCG less than 5,000 IU/mL and lactate dehydrogenase (LDH) less than 3.0 x normal; age at least 11 and less than 25 years
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03067181

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANBL1531 (CIRB): A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Eligibility

  • Subject is between 1 year and 30 years of age
  • Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • The following disease groups are eligible:
  • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
    • MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; or
    • Age greater than 547 days regardless of biologic features
  • Patients with INRG stage MS disease with MYCN amplification
  • Patients with INRG stage L2 disease with MYCN amplification
  • Patients greater than 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within four weeks of progression to stage M
  • Patients at least 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within four weeks of progression to stage M

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03126916

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AGCT1532 A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors

Eligibility

  • Subject is between 11 - 45 years of age
  • Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma), or
  • Exceptionally raised tumor markers (AFP at least 1000ng/mL and/or HCG at least 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  • Metastatic disease or non-testicular primary
  • Intermediate or poor prognosis

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02582697

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between 1 month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AREN1921, Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04322318

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AHEP1531 Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03533582

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# 153036) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA PEPN1924 

Eligibility

  • Subject is between 12 - 39 years of age
  • Osteosarcom having received at least standard initial therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04616560

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB,AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thuoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma 

Eligibility

  • Subject is no older than 50 years of age
  • Osteosarcoma
  • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of first recurrence following completion of therapy for initially localized disease
  • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05235165

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2031:A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features

Eligibility

  • Subject is between 3 years and 22 years of age
  • Must be newly diagnosed medulloblastoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05382338

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

PEPN2121: A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Eligibility

  • Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors 
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
    • Other SMARCB1 or SMARCA4 deficient tumors
  • Subject must be at least 12 months of age 
  • Part A, patients must be less than 18 years old
  • Part B, patients must be 18 years or older

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05286801

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

Eligibility

  • Patients must be less than 40 years of age at time of enrollment.
  • Patients must have a body surface area of greater than or equal to 0.8m2 at the time of enrollment.
  • Patients must have a histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05691478

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

Eligibility

  • Male or female ≤ 30 years at the time of initial diagnosis with high-risk disease
  • Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
  • Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
  • Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:
    • Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification
    • Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)
    • Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy
    • Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)
  • Exclusion Criteria
    • Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features
    • Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features
    • Patients with known bone marrow failure syndromes
    • Patients on chronic immunosuppressive medications (eg, tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable
    • Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
    • All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06172296

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

Eligibility

  • Male or female < 18 years of age
  • For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL/Burkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues
  • For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma
  • Exclusion Criteria
    • History of solid organ transplant
    • Clinically significant (ie, active) cardiovascular disease
    • Known history of liver cirrhosis
    • Ongoing Grade >1 peripheral neuropathy
    • Demyelinating form of Charcot-Marie-Tooth disease
    • Diagnosed with Down syndrome
    • Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis
    • History of human immunodeficiency virus (HIV) infection
    • Contraindication or hypersensitivity to any of the study intervention components
    • Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities
    • Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1)
    • Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06395103

Principal Investigator

Andrew Bellantoni, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

  

A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects with Selected Advanced Unresectable and Metastatic Solid Tumors

Eligibility

  • Male or female ≥18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Must have a locally advanced or metastatic inoperable tumor as follows:
    • For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS.
    • For the expansion phase: CRC. Note: if additional indications and combinations are added inclusion/exclusion criteria will be updated.
  • Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the Investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis.
  • In the Investigator's opinion, the subject may not derive clinical benefit from, or is ineligible for, a particular form of standard therapy on medical grounds, or the subject failed or did not tolerate one or more of other anticancer therapies:
    • For the dose escalation phase:
      • Refractory, intolerant, or refused available standard-of-care therapies.
      • Up to three previous lines of systemic anticancer therapies for metastatic disease are allowed (adjuvant or neoadjuvant setting do not count as lines of systemic therapy).
      • Subjects with TNBC or OC with known BRCA mutations must have been previously treated with or intolerant to Food and Drug Administration (FDA) approved treatments prior to enrolling in this study (e.g., iPARP).
      • Subjects with OC must have been treated with, refused, or were ineligible for treatment with bevacizumab to enroll.
      • Subjects with CRC tumors that are MSI-H/dMMR must have received, refused or be intolerant to a checkpoint inhibitor (CPI).
      • Subjects with HCC must have confirmed diagnosis of inoperable hepatocellular carcinoma by histology or clinical/radiological criteria. No more than two prior lines of
        systemic therapy only and Child Pugh Score A or B7.
    • For the expansion phase:
      • For all cohorts: Subjects with MSI-H/dMMR must have received, refused or be intolerant to a CPI.
      • Cohort 1 ST316 monotherapy: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of four prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-vascular-endothelial growth factor (VEGF), anti-epidermal growth factor receptor (EGFR) targeted agents (as indicated).
      • Cohort 2: Combination with standard of care (SOC) FOLFIRI +bevacizumab: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of one prior line of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF. Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first line of treatment.
      • Cohort 3: Combination with fruquintinib: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.
      • Cohort 4: Combination with Lonsurf + beva: CRC that has progressed after or on treatment with all of the following, alone or in combination, comprising a maximum of two prior lines of therapy for their advanced/metastatic disease: oxaliplatin, irinotecan, fluoropyrimidines or anti-VEGF Subjects with RAS wild-type must have been treated with an anti-EGFR targeted agent during the first or second line of treatment.
    • Evaluable disease per RECIST 1.1 with at least one target lesion.
    • All previous anticancer therapy-related AEs should have resolved to Grade 1 or baseline value with the exception of alopecia and stable, treated endocrine toxicities of immune CPIs.
  • Exclusion Criteria
    • Known hypersensitivity to ST316 or any of its excipients.
    • Known hypersensitivity to bevacizumab, 5-FU, leucovorin or irinotecan for Cohort 2, to fruquintinib for Cohort 3 and trifluridine or tipiracil for Cohort 4 in the expansion.
    • Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) > 480 msec using Fredericia's formula.
    • Symptomatic ascites or pleural effusion. A subject who is clinically stable for 4 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
    • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks prior to study entry and have no evidence of new or enlarging brain metastases. Subjects with treated brain metastases must also follow the steroid exclusion criterion (#11) listed below.
    • For expansion phase only: presence of any other active malignancy requiring systemic therapy other than the disease under study.
    • History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or intraabdominal abscess within 6 months.
    • Ongoing serious, non-healing wound, ulcer, or bone fracture.
    • History of reversible posterior leukoencephalopathy syndrome (RPLS).
    • History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human or humanized recombinant antibodies.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05848739

Principal Investigator

Marjorie Zauderer, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)

Eligibility

  • Male or Female, 21 years of age or younger.
  • Newly diagnosed PPB. Note that patients with known germline DICER1 variant or mosaicism with a large, solid unresectable thoracic mass with imaging features characteristic for Type II or III PPB are eligible without histologic confirmation of the diagnosis if a biopsy of the mass is not considered safe or feasible.
    • Individuals are eligible based on institutional diagnosis of Type I, Ir, II or III PPB diagnosed within 60 days prior to enrollment. Children with Type II or III PPB at risk for clinical decompensation may receive protocol therapy while awaiting rapid central pathology review. Children with Type I or Ir PPB will be assigned to chemotherapy vs. observation based on imaging and central pathology review diagnosis. Type I and Ir patients should not begin chemotherapy prior to return of central pathology results.
  • Organ Function Requirements:
    • There are no specific organ function requirements for patients with Type I or Ir PPB.
  • For patients with Type II or III PPB (within 7 days prior to enrollment): A serum creatinine based on age/sex as follows:
    • Age: 1 month to < 6 months - Maximum Serum Creatinine (mg/dL): 0.4 (Male), 0.4 (Female)
    • Age: 6 months to < 1 year - Maximum Serum Creatinine (mg/dL): 0.5 (Male), 0.5 (Female)
    • Age: 1 to < 2 years - Maximum Serum Creatinine (mg/dL): 0.6 (Male), 0.6 (Female)
    • Age: 2 to < 6 years - Maximum Serum Creatinine (mg/dL): 0.8 (Male), 0.8 (Female)
    • Age: 6 to < 10 years - Maximum Serum Creatinine (mg/dL): 1 (Male), 1 (Female)
    • Age: 10 to < 13 years - Maximum Serum Creatinine (mg/dL): 1.2 (Male), 1.2 (Female)
    • Age: 13 to < 16 years - Maximum Serum Creatinine (mg/dL): 1.5 (Male), 1.4 (Female)
    • Age: ≥ 16 years - Maximum Serum Creatinine (mg/dL): 1.7 (Male), 1.4 (Female) OR - A 24 hour urine creatinine clearance ≥ 60 mL/min/1.73 m^2 OR - A glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
      Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
  • For patients with Type II or III PPB (within 7 days prior to enrollment): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  • For patients with Type II or III PPB (within 7 days prior to enrollment): Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L.
    Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  • Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram (within 21 days prior to start of protocol therapy).
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4.
  • Exclusion Criteria
    • Administration of prior PPB-directed chemotherapy is an exclusion criterion. Prior treatment for another malignancy is not an exclusion criterion.
    • Patients with known Charcot-Marie-Tooth disease.
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
    • Lactating females who plan to breastfeed their infants.
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
    • All patients and/or their parents or legal guardians must sign a written informed consent.
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06647953

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Brain Tumors

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • 1 month - 17 years of age at time of study entry
  • Has a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement 
  • Is a candidate to receive myelosuppressive chemotherapy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between 1 year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1422 (CIRB) A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Eligibility

  • Subject is between 3 years and 21 years of age
  • Classical histologic type (non LC/A) WNT medulloblastoma that is Positive nuclear beta-catenin by immunohistochemistry (IHC), Positive for CTNNB1 mutation and Negative for MYC and MYCN by fluorescence in situ hybridization (FISH); negative CNS on lumbar puncture

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02724579

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

HEAD START 4 PROTOCOL:  Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Embryonal Tumors. Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Randomization to either Single-Cycle or to Three Sequential Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue

Eligibility

  • Subject is no more than 10 years of age
  • Diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02875314

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1831, CIRB A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Eligibility

  • Subject is between 2 and 21 years of age
  • Neurofibromatosis type 1 (NF1)
  • Newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
  • Optic pathway gliomas

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03871257

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Eligibility

  • Subject is between 2 and 21 years of age
  • Non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04166409

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1931, A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas

Eligibility

  • Subject is between 2 and 25 years of age
  • Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation
  • Progressive or recurrent LGG
  • Metastatic disease or multiple independent primary LGGsl
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04576117

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2021, A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Eligibility

  • Subject is between 3 and 30 years of age
  • Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or greater than 10 ng/mL or human chorionic gonadotropin (hCG) beta greater than 100 mIU/mL
  • Suprasellar, pineal and bifocal tumors are included
  • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04684368

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Eligibility

  • Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
  • Willing and able to provide informed consent and to participate in all evaluations

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04427384

Principal Investigator

Simon Hanft, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

 

 

Radiation Medicine


Testing the addition of radiation therapy to the usual immune therapy treatment (atezolizumab) for patients with extensive stage small cell lung cancer (NRG-LU007: Randomized Phase II/III Trial Of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR trial)

Eligibility

  • Subject is at least 18 years of age
  • Diagnosis of extensive stage small cell lung cancer
  • Partial response or stable response after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab  
  • Must have measurable disease and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04402788

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Testing the addition of high dose, targeted radiation to the usual treatment for locally advanced inoperable non-small cell lung cancer (NRG-LU008, Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer)

Eligibility

  • Subject is at least 18 years of age
  • Diagnosis of stage II or III non-small cell lung cancer (NSCLC) with known PD-L1 status 
  • Must have an identified primary tumor and at least one nodal metastasis 
  • Up to 4 cycles of systemic therapy received prior to registration is allowable; any prior chemotherapy for a different cancer is also permissible
  • No evidence of distance metastases based on FDG PET/CT scan

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05624996

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Two Studies for Patients With High-Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial  (NRG-GU-009: Parallel Phase III Randomized Trials for High-Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of High-risk adenocarcinoma of prostate cancer (PSA>20ng/mL or cT3a-T4 or Gleason Score 8-10 or Node positive)
  • Is not metastatic disease outside of the pelvic nodes (M1a, M1b, or M1c) on imaging
  • No Prior systemic chemotherapy within 3 years and No prior radiotherapy to the region of the study cancer

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04513717

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score (NRG-GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of intermediate-risk adenocarcinoma of prostate cancer (PSA 10-20 ng/mL or stage T2b-c or Gleason Score 7) 
  • No previous radical surgery (prostatectomy) or any form of curative-intent ablation for prostatic cancer 
  • No prior hormonal therapy and No prior radiotherapy to the prostate/pelvis region

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05050084

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Comparing Observation Versus Radiation for Newly Diagnosed Grade II Meningiomas That Have Been Completely Removed Through Surgery (NRG-BN003. Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma)

Eligibility

  • Subject is at least 18 years of age 
  • Diagnosis of unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II 
  • Is not optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma, or metastatic meningioma 
  • No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT03180268

Principal Investigator

Keith Meritz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

The Phase III 'High Five Trial' Five Fraction Radiation for High-risk Prostate Cancer

Eligibility

  • Male at least 18 years of age
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the primary outcome are eligible for this trial
  • Men who are sexually active should be willing and able to use medically acceptable forms of contraception during treatment and for 90 days after end of Radiation Therapy
  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
  • No prior radical prostatectomy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05946213

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy For Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery [ERASur]

Eligibility

  • Male or female ≥ 18 years
  • Histologically-confirmed metastatic colorectal adenocarcinoma
  • No known microsatellite instable (MSI) tumor
  • No known BRAF V600E mutation
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
  • Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
  • Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  • Patients must have no overt evidence of disease progression during systemic therapy prior to registration
  • Patients must be receiving (or have received) first-line systemic therapy for metastatic disease for a minimum of 16 weeks and a maximum of 26weeks
  • For women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05946213

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Phase III Clinical Trial Evaluating DE-escalation of Breast RAdiation (DEBRA) for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score ≤ 18 Breast Cancer

Eligibility

  • Male or female ≥ 50 years and < 70 years of age
  • The patient must have an ECOG performance status of 0 or 1
  • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins
    (Patients with margins positive for LCIS are eligible without additional resection.)
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
  • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection)
  • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
    • By pathologic evaluation, primary tumor must be pT1 (≤ 2 cm)
    • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
  • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with  1% ER or PgR staining by IHC are considered positive
  • Exclusion Criteria:
    • Definitive clinical or radiologic evidence of metastatic disease
    • pT1mi and pT2–pT4 tumors including inflammatory breast cancer
    • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease
    • Patient had a mastectomy
    • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
    • Non-epithelial breast malignancies such as sarcoma or lymphoma
    • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
    • Paget’s disease of the nipple

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04852887

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)

Eligibility

  • Male or female ≥ 40 years of age
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information
  • Female and Male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy
  • ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60
  • Histologically or cytologically confirmed invasive breast carcinoma
  • Tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results
  • Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0)
  • Exclusion Criteria:
    • Definitive clinical or radiologic evidence of metastatic disease
    • On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination
    • Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease
    • Patient planning for or status-post mastectomy
    • Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease
    • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign
    • Non-epithelial breast malignancies such as sarcoma or lymphoma
    • Paget's disease of the nipple
    • Treatment plan that includes regional nodal irradiation

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05705401

Principal Investigator

Aviva Berkowitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org


A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG PROMETHEAN)

Eligibility

  • Male ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 120 days prior to registration
  • Prior curative-intent treatment to the prostate, by either:
    • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles,
      prostate and pelvic nodes, or radiation to all three sites
    • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to
      the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the
      pelvic nodes
  • Must meet study entry criteria based on the following diagnostic workup within 180 days
    prior to registration:
    • History and physical examination;
    • Fluciclovine or PSMA PET scan (Must be positive with exception of local disease);
      PET must be combined with either CT or MRI, but a diagnostic CT or MRI
      reading/interpretation is not required
  • 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or
    PSMA PET within 180 days prior to registration and includes at least ONE of the
    following:
    • Bone – each metastasis is counted (for example, 2 distinct lesions in the right ilium
      count as 2 oligometastatic lesions),
    • Extrapelvic Nodal/ soft tissue – requires at least one extrapelvic inguinal or a
      nodal/soft tissue lesion superior to the iliac bifurcation (that is, AJCC M1a version 8).
  • Must have > 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
  • Serum total testosterone >100 ng/dL within 180 days prior to registration
  • Exclusion Criteria:
    • Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
    • Currently on androgen deprivation or anti-androgen therapy
    • Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
      • Osseous metastasis on 99mTc radionuclide bone scan, or
      • Extra pelvic nodal/soft tissue disease (> 1.5 cm in short axis) on CT or MRI pelvis +/- abdomen
    • Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
    • Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05053152

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Eligibility

  • Male ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 120 days prior to registration
  • Prior curative-intent treatment to the prostate, by either:
    • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles,
      prostate and pelvic nodes, or radiation to all three sites
    • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to
      the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the
      pelvic nodes
  • Must meet study entry criteria based on the following diagnostic workup within 180 days
    prior to registration:
    • History and physical examination;
    • Fluciclovine or PSMA PET scan (Must be positive with exception of local disease);
      PET must be combined with either CT or MRI, but a diagnostic CT or MRI
      reading/interpretation is not required
  • 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or
    PSMA PET within 180 days prior to registration and includes at least ONE of the
    following:
    • Bone – each metastasis is counted (for example, 2 distinct lesions in the right ilium
      count as 2 oligometastatic lesions),
    • Extrapelvic Nodal/ soft tissue – requires at least one extrapelvic inguinal or a
      nodal/soft tissue lesion superior to the iliac bifurcation (that is, AJCC M1a version 8).
  • Must have > 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
  • Serum total testosterone >100 ng/dL within 180 days prior to registration
  • Exclusion Criteria:
    • Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
    • Currently on androgen deprivation or anti-androgen therapy
    • Definitive radiologic evidence of metastatic disease on conventional imaging, defined by one of the following:
      • Osseous metastasis on 99mTc radionuclide bone scan, or
    • Extra pelvic nodal/soft tissue disease (> 1.5 cm in short axis) on CT or MRI pelvis +/- abdomen
    • Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
    • Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05053152

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

 

Transplants

 

A Phase II Intrapatient Open-Label Dose Escalation Trial of Defibrotide in Hematopoietic Cell Transplantation (HCT) Recipients with Sinusoidal Obstructive Syndrome (SOS) Post-HCT Associated with either Renal and/or Pulmonary Dysfunction with Either Refractory or Progressive Disease Following Defibrotide Therapy

Eligibility

  • Male or female, Age 1 month - 75 years
  • HCT recipients (Auto or Allograft)
  • SOS/VOD as defined by Cairo/Cooke Diagnostic criteria (1) (Table 3) with either renal and/or pulmonary dysfunction as defined by Cairo/Cooke Grading criteria (1) (Appendix I)
  • Unresponsive to standard defibrotide therapy as defined by at least one of the following:
    • Patients with SOS/VOD failing to obtain a complete response (CR) defined by Grade I or less by Cairo/Cooke Grading criteria (1) (Appendix I). This would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day).
    • Progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by Cairo/Cooke Grading criteria (1) (Appendix I) following at least 7 days of defibrotide (25mg/kg/day).
  • Exclusion Criteria
    • Patients who did not receive HCT
    • Concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of CVVH)
    • Active bleeding and/or hemorrhage of at least grade 2 and above
    • History of development of Grade III/IV anaphylaxis probably or directly secondary to defibrotide
    • Female patients who are pregnant or breast feeding

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05987124

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants with Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Eligibility

  • Male and female participants at least 12 years of age who have had allogeneic HCT.
  • Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
  • Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
  • Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
  • Have persistent cGVHD manifestations and systemic therapy is indicated.
  • Karnofsky (if aged ≥16 years) / Lansky (if aged <16 years) Performance Score of ≥60.
  • At least 12 years of age; weight ≥ 40 kilograms (kg).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Exclusion Criteria
    • Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
    • Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
    • Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
    • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease).
    • Corrected QT interval using Fridericia's formula (QTc[F]) > 480 ms.
    • Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05567406

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Myeloma

 

A Phase 3, Open-Label Study of Elranatamab Monotherapy Versus Elotuzumab, Pomalidomide, Dexamethasone (EPd) or Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilizomib, Dexamethasone (Kd) in Participants with Relapsed/Refractory Multiple Myeloma Who Received Prior Anti-CD38 Directed Therapy

Eligibility

  • Male or female, 18 years or older
  • Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria
  • Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
  • Have clinical laboratory values within the specified range
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2
  • Not pregnant or breastfeeding and willing to use contraception
  • Exclusion Criteria
    • Smoldering multiple myeloma
    • Plasma cell leukemia
    • Amyloidosis
    • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome
    • Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
    • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease
    • Any active, uncontrolled bacterial, fungal, or viral infection
    • Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
    • Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy
    • Unable to receive investigator's choice therapy
    • Live attenuated vaccine within 4 weeks of the first dose of study intervention
    • Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06152575

Principal Investigator

Amir Steinberg, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

A Randomized, 2-Arm, Phase 3 Study of Elranatamab (PF-06863135) Versus Lenalidomide in Patients with Newly Diagnosed Multiple Myeloma After Undergoing Autologous Stem-Cell Transplantation

Eligibility

  • Male or female, 18 years or older
  • Diagnosis of MM as defined according to IMWG criteria1 with measurable disease at diagnosis as defined by serum M-protein ≥0.5 g/dL (5 g/L), by urine M-protein ≥200 mg/24 hours, or by serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL, provided serum FLC ratio is abnormal
  • History of 3 to 8 cycles of induction therapy for NDMM, followed by high dose therapy and ASCT. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT. Screening tests should be performed after the last dose of consolidation
  • PR or better according to IMWG criteria at the time of randomization
  • Identification of the dominant malignant (index) clone as assessed by central laboratory NGS test (Adaptive Biotechnologies clonoSEQ assay
  • A bone marrow aspirate sample collected at screening is required to determine MRD status
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  • Not pregnant and willing to use contraception
  • Exclusion Criteria
    • Plasma cell leukemia defined as more than 20% circulating plasma cells and an absolute count >2 × 10 ⁹ /L plasma cells in peripheral blood) ².
    • Amyloidosis, Waldenström’s macroglobulinemia, or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome
    • Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
    • Ongoing Grade ≥3 peripheral sensory or motor neuropathy
    • History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy
    • Live attenuated vaccine within 4 weeks of the first dose
    • Known or suspected hypersensitivity to the study interventions or any of its excipients
    • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per the investigator
    • Previous MM maintenance treatment
    • Prior treatment with B-cell maturation antigen (BCMA) targeted therapy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05317416

Principal Investigator

Amir Steinberg, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

 

Sarcoma

 

A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Eligibility

  • Patients must be ≤ 21 years at the time of enrollment.
  • Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable).
  • All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.
    • Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.
    • Patients will be eligible for the low-risk stratum (Regimen VAC/VA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.
  • Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients ≥ 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.
  • Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.
  • Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.
  • Exclusion Criteria
    • Patients who have received prior chemotherapy and/or radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.
    • Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
    • Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.
    • Evidence of uncontrolled infection.
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
    • Lactating females who plan to breastfeed their infants.
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05304585

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Mesothelioma

 

A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed Versus Platinum plus Pemetrexed or Nivolumab plus Ipilimumab in Participants with Unresectable Pleural Mesothelioma (eVOLVE-Meso)

Eligibility

  • Male or Female, Age ≥ 18 years at the time of screening.
  • Histologically proven diagnosis of PM with known histology (epithelioid vs. non-epithelioid).
  • Advanced unresectable disease that cannot be treated with surgery with curative intent (with or without chemotherapy).
  • WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS > 1) over the previous 2 weeks prior to day of first dosing.
  • Life expectancy ≥ 12 weeks
  • Provision of existing (leftover) tumor sample obtained within 6 months prior to screening is required, if available.
  • Measurable disease, per investigator assessment, defined as:
    • Mesothelioma tumor thickness perpendicular to the chest wall or mediastinum, that can be measured in up to 2 positions at 3 separate levels on transverse cuts of CT scan (cuts must be at least 10 mm apart), for a total of up to 6 measurements. Each single tumor measurement must be at least 7 mm to qualify as measurable disease and contribute to the sum that defines the pleural measurement as per mRECIST 1.1 criteria.
    • Non-pleural metastatic target lesions measured uni-dimensionally as per RECIST 1.1 criteria.
    • Patients who present without pleural lesions that can be considered measurable, but with metastatic lesions (non-pleural) meeting criteria for target lesion by RECIST 1.1 criteria may be considered for inclusion, based upon the investigator’s judgment.
  • Body weight > 35 kg
  • Exclusion Criteria
    • As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
    • History of another primary malignancy except for:
      • Malignancy treated with curative intent and adequate follow-up with no known active disease or have not required active treatment within the past 2 years before the first dose of study intervention and of low potential risk for recurrence.
      • Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
      • Adequately treated carcinoma in situ, including Ta bladder tumors, without evidence of disease. Cancer participants with incidental histologic findings of prostate cancer that, in the opinion of the investigator, is not deemed to require active therapy (eg, incidental prostate cancer identified following cystoprostatectomy that is tumor/node/metastasis stage ≤ pT2N0) may be enrolled, pending discussion and approval by the investigator.
    • Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, pneumonitis (past medical history of ILD, drug-induced ILD, or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD), etc. The following are exceptions to this criterion:
      • Participants with vitiligo or alopecia.
      • Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
      • Any chronic skin condition that does not require systemic therapy.
      • Participants without active disease in the last 5 years prior to enrolment may be included.
      • Participants with celiac disease controlled by diet alone.
    • History of active primary immunodeficiency.
    • Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression. Participants with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry. The following participants can be included:
      • Participants previously treated with radiation or surgical resection within 3 months prior to first dose of investigational products for CNS metastases who are asymptomatic, and clinically stable who do not require corticosteroids for at least 14 days prior to the first dose of investigational product.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06097728

Principal Investigator

Marjorie Zauderer, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

 

Non-Small-Cell Lung

 

A Phase 3 Randomized and Double-Blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants with Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab with Platinum-Based Doublet Chemotherapy (INTerpath-009)

Eligibility

  • Male or Female, Age ≥ 18 years at the time of screening.
  • Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition].
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention.
  • Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible.
  • Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]).
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
  • Exclusion Criteria
    • Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor.
    • Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements.
    • Received prior neoadjuvant therapy for their current NSCLC diagnosis.
    • Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137).
    • Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol.
    • Received prior treatment with a cancer vaccine.
    • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
    • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06623422

Principal Investigator

Marjorie Zauderer, MD

Contact for Study Screening

Allyson.Pulsoni@wmchealth.org

 

 

Pediatrics

 

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

Eligibility

  • Male or Female, < 30 years old at enrollment.
  • Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening prior to enrollment on AREN2231.
  • Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1.
  • Patients must receive a qualifying Initial Stratum Assignment on APEC14B1 by Day 14 post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.
    • Patients must enroll on AREN2231 by Day 14.
    • Exceptions: If patient reaches Day 14 (post initial diagnostic nephrectomy or biopsy) without receiving an Initial Stratum Assignment on APEC14B1, patient will not be eligible for enrollment on AREN2231 unless all required materials (reports and Case Report Forms and specimens) for an Initial Stratum Assignment arrived by Day 7, but an Initial Stratum Assignment was not completed by Day 14. In these circumstances, after obtaining appropriate protocol consent, the patient may proceed with treatment according to local institutional staging and enroll within 5 calendar days of notification of the central Initial Stratum Assignment being issued, only if the AREN2231 Initial Stratum Assignment is in agreement with any treatment already initiated. If the Initial Stratum Assignment is not in agreement with the local institution's assessment then the patient will be ineligible for AREN2231.
  • All sites must have sent or plan to send diagnostic tumor sample for molecular testing through a Clinical Laboratory Improvement Act (CLIA)-certified (or equivalent if outside of the United States [US]) laboratory that can detect Loss of Heterozygosity (LOH) of chromosome 1p AND 16q, and gain of chromosome 1q. Patients potentially eligible for mVLR must also have LOH of chromosome 11p15 included.
    • Note: Patients are eligible for enrollment before these results are available; however, molecular results must be returned and uploaded to APEC14B1 for integration into risk stratification by the required timepoints (specific timelines vary by treatment arm). Patients who do not have molecular results available by the arm-specific timepoints may be taken off protocol therapy.
  • Patients who have an upfront nephrectomy must have at least one lymph node sampled and confirmed as a lymph node by central pathology review to be eligible.
    • Note: Lymph node sampling will also be required at delayed nephrectomy. Patients who do not have a lymph node sampled and confirmed as a lymph node by central pathology review at delayed nephrectomy will be taken off protocol therapy.
  • Karnofsky performance status must be 50 for patients > 16 years of age and the Lansky performance status must be 50 for patients ≤ 16 years of age.
  • Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) OR direct bilirubin ≤ 3X ULN for subjects with total bilirubin levels > 1.5 ULN (within 7 days prior to enrollment)
  • Aspartate aminotransferase (AST/serum glutamate oxaloacetic transaminase [SGOT]) OR alanine transaminase (ALT/serum glutamic pyruvate transaminase [SGPT]) ≤ 3X ULN OR ≤ 5 X ULN for patients with liver metastases (within 7 days prior to enrollment).
  • Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% (within 7 days prior to enrollment)
    • Note: This criteria only applies to patients centrally classified as Stage IV. Stage II and III patients subsequently assigned to a doxorubicin arm will be off protocol therapy if they do not meet this criterion at time of cardiac function assessment.
  • Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
  • Exclusion Criteria
    • Patient with a diagnosis of Stage V Bilateral Wilms Tumor.
    • Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.
    • Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and/or unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.
    • Patients treated with partial nephrectomy at initial diagnosis are excluded from mVLR (Nephrectomy Only) arm.
    • Patients with lung metastases as the only metastatic site who already had complete resection of all radiologically evident lung nodules, and have at least one nodule confirmed pathologically as tumor.
      • Please note: Those with lung metastases as the only metastatic site who have complete resection of all radiologically evident lung nodules after enrollment but prior to the lung imaging following Cycle 2 of DD-4A will be inevaluable for lung assessment and subsequent stratum assignment and will, therefore, come Off Protocol Therapy.
    • Patients who have had prior tumor-directed chemotherapy or radiotherapy for the current diagnosis except for therapy delivered for an emergent issue, as medically indicated.
    • Patients who will potentially require doxorubicin on this study and have previously received doxorubicin for another diagnosis.
    • Patients receiving concurrent chemotherapy for a different diagnosis.
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
    • Lactating females who plan to breastfeed their infants.
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06401330

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

lauren_harrison@nymc.edu