Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395090
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-29
Brief Title:
A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors MK-9999-01BLIGHTBEAM-U01
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
LIGHTBEAM-U01 Substudy 01B A Phase 12 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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-Hmismatch 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
There will be no hypothesis testing in this study
Detailed Description:
The master screening protocol is MK-9999-U01
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-9999-01B | OTHER | None | None |
| LIGHTBEAM-U01 | OTHER | None | None |
| 2023-507179-23 | REGISTRY | EU CT | None |