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LIGHTBEAM-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.
EU CTIS ID: 2023-507179-23-00
What this study is testing
1. Part 1 and Part 2: To determine the safety and tolerability of study interventions. 2. Part 1: To evaluate PK profile of each investigational agent. 3. Part 1 and Part 2: To evaluate ORR per Lugano response criteria by BICR for cHL and per RECIST 1.1 by investigator per solid tumor type
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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)
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Taiwan
- Turkey
- United Kingdom
- Korea, Republic of
- Israel
- Chile
- Canada
- Colombia
- Mexico
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Taiwan; Turkey; United Kingdom; Korea, Republic of; Israel and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.