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)

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The master screening protocol is MK-9999-U01.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
BIOLOGICAL	Favezelimab	IV infusion
BIOLOGICAL	Favezelimab/Pembrolizumab	IV infusion
BIOLOGICAL	Vibostolimab	IV infusion
BIOLOGICAL	Pembrolizumab/Vibostolimab	IV infusion

Timeline

• Start date: 2025-01-15
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2024-05-01
• Last updated: 2025-04-08

Locations

12 sites across 3 countries: United States, South Korea, Taiwan

Regulatory

• FDA-regulated drug study