IGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination with Investigational Agents in Pediatric and Young Adult Participants with Hematologic Malignancies or Solid Tumors.

Phase 1

• Conditions: Hematologic Malignancies or Solid Tumors in Pediatric and Young Adults; MedDRA version: 21.1Level: LLTClassification code: 10066481Term: Hematological malignancy Class: 10029104; MedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-507179-23-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL), that may be programmed cell death 1 protein (PD-1) naïve or PD-1 exposed (eligible for Arm 1 only), advanced melanoma that may be PD-1 naïve or PD-1 exposed (eligible for Arm 2 only), solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), that may be PD-1 naïve or PD-1 exposed (eligible for Arm 2 only) or solid tumors that are tumor mutational burden-high (TMB-H), that may be PD-1 naïve or PD-1 exposed (eligible for Arm 2 only)., Must have recovered from all AEs from previous anticancer therapies, Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria

HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease., History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Active infection requiring systemic therapy., Concurrent active Hepatitis B and Hepatitis C virus infection., History of allogenic tissue/solid organ transplant., Has symptoms of or is being treated for graft versus host disease (GVHD), Has not adequately recovered from major surgery or have ongoing surgical complications., Known tumors involving the brainstem., Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention., 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., Received prior anticancer therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) in combination with either an Anti- lymphocyte-activation gene 3 (LAG-3) agent or an Anti- T-cell immunoreceptor with immunoglobulin (Ig) and ITIM domains (TIGIT) agent., Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention., Known additional malignancy that is progressing or has required active treatment within the past 1 year., Known active central nervous system (CNS) metastases and/or carcinomatous meningitis., Active autoimmune disease that has required systemic treatment in the past 2 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified