KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04165096
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    IV infusion
  • Boserolimab — BIOLOGICAL
    IV infusion
  • MK-4830 — BIOLOGICAL
    IV infusion
  • diphenhydramine — DRUG
    PO
  • acetaminophen — DRUG
    PO
  • MK-0482 — BIOLOGICAL
    IV infusion

Study Details

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with boserolimab (MK-5890), MK-4830, MK-0482 in participants with advanced squamous or non-squamous NSCLC that have been previously treated with anti-PD-L1 therapy. This study is one of three pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Key Dates

Start date
Jan 21, 2020
Status verified
Apr 2026
Primary completion
Apr 30, 2025
Completion
May 28, 2025

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Boserolimab
    On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS boserolimab IV for a maximum of 35 cycles (approximately 2 years). All participants are premedicated 1.5 hours (±30 minutes) before infusion of boserolimab with 50 mg oral (PO) diphenhydramine (or equivalent dose of antihistamine) and 500-1000 mg of acetaminophen PO (or equivalent dose of analgesic).
  • Experimental: Pembrolizumab + MK-4830
    On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-4830 IV for a maximum of 35 cycles (approximately 2 years).
  • Experimental: Pembrolizumab + MK-0482
    On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-0482 IV for a maximum of 35 cycles (approximately 2 years).

Primary Outcome Measure

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 53 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer Center ( Site 0001)GilbertArizona85234-
City of Hope ( Site 0014)DuarteCalifornia91010-
UCSF Medical Center at Mission Bay ( Site 0007)San FranciscoCalifornia94158-
Georgetown University ( Site 0036)Washington D.C.District of Columbia20007-
University of Kentucky Markey Cancer Center ( Site 0019)LexingtonKentucky40536-0293-
MedStar Franklin Square Medical Center ( Site 0033)BaltimoreMaryland21237-
Dana Farber Cancer Institute ( Site 0002)BostonMassachusetts02215-
Massachusetts General Hospital ( Site 0003)BostonMassachusetts02114-
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)OmahaNebraska68130-
Dartmouth Hitchcock Medical Center ( Site 0016)LebanonNew Hampshire03766-
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)HackensackNew Jersey07601-
Laura and Isaac Perlmutter Cancer Center ( Site 0034)New YorkNew York10016-
Sanford Fargo Medical Center ( Site 0039)FargoNorth Dakota58102-
Cleveland Clinic Main ( Site 0006)ClevelandOhio44195-
Ohio State University Comprehensive Cancer Center ( Site 0015)ColumbusOhio43210-
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)PhiladelphiaPennsylvania19104-
Sanford Cancer Center ( Site 0038)Sioux FallsSouth Dakota57104-
The University of Texas MD Anderson Cancer Center ( Site 0009)HoustonTexas77030-

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Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZCity of Hope· Duarte, CAUCSF Medical Center at Mission Bay· San Francisco, CAGeorgetown University· Washington D.C., DCUniversity of Kentucky Markey Cancer Center· Lexington, KYMedStar Franklin Square Medical Center· Baltimore, MD

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