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Trial Title:
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)
NCT ID:
NCT06395090
Condition:
Neoplasm Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Hematologic Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
IV infusion
Arm group label:
Favezelimab + Pembrolizumab
Arm group label:
Pembrolizumab + Vibostolimab
Other name:
MK-3475
Intervention type:
Biological
Intervention name:
Favezelimab
Description:
IV infusion
Arm group label:
Favezelimab + Pembrolizumab
Intervention type:
Biological
Intervention name:
Favezelimab/Pembrolizumab
Description:
IV infusion
Arm group label:
Favezelimab/Pembrolizumab
Other name:
MK-4280A
Intervention type:
Biological
Intervention name:
Vibostolimab
Description:
IV infusion
Arm group label:
Pembrolizumab + Vibostolimab
Intervention type:
Biological
Intervention name:
Pembrolizumab/Vibostolimab
Description:
IV infusion
Arm group label:
Pembrolizumab/Vibostolimab
Other name:
MK-7684A
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Must have 1 of the following histologically or cytologically confirmed diagnosis of
Relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors that are
microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid
tumors that are tumor mutational burden-high (TMB-H)
- 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
- 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
- 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
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale-New Haven Hospital ( Site 2012)
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
203-785-4640
Facility:
Name:
University of Iowa-Holden Comprehensive Cancer Center ( Site 2017)
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
319-356-7673
Facility:
Name:
Rutgers Cancer Institute of New Jersey ( Site 2008)
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
908-217-0856
Facility:
Name:
New York Medical College ( Site 2023)
Address:
City:
Valhalla
Zip:
10595
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
914-614-4270
Facility:
Name:
Intermountain - Primary Children's Hospital ( Site 2014)
Address:
City:
Salt Lake City
Zip:
84113
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
801-662-4700
Facility:
Name:
Seoul National University Hospital-Pediatrics ( Site 2972)
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82220723304
Facility:
Name:
Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 2973)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82230105994
Start date:
November 14, 2024
Completion date:
June 30, 2029
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395090
https://www.merckclinicaltrials.com/
https://msd.trialsummaries.com/Study/StudyDetails?id=26121&tenant=MT_MSD_9011
