drugset / Trial / NCT06395090
A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H). This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2). Participants will be assigned to a treatment arm (either Part 1 or Part 2) that is open for enrollment. There will be no hypothesis testing in this study.
Timeline
- Start
- 2025-01-15
- Primary completion
- 2029-06-30
- Completion
- 2029-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Favezelimab | Unknown | — | Intravenous |
| Subject | Favezelimab/Pembrolizumab | Unknown | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Pembrolizumab/Vibostolimab | Unknown | — | Intravenous |
| Subject | Vibostolimab | Monoclonal antibody | — | Intravenous |