Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04738487
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab/Vibostolimab — BIOLOGICAL
    Coformulation of pembrolizumab (MK-3475) 200mg and vibostolimab (MK-7684) 200mg. Participants receive the coformulation by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).
  • Pembrolizumab — BIOLOGICAL
    Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).

Study Details

Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.

Key Dates

Start date
Apr 7, 2021
Status verified
Jan 2026
Primary completion
Sep 5, 2024
Completion
Jan 27, 2026

Study Design

Enrollment
1,264 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab/Vibostolimab
    Participants received 200 mg pembrolizumab / 200 mg vibostolimab as a coformulation (MK-7684A) by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations, until centrally verified disease progression, or until a protocol specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received a second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).
  • Active Comparator: Pembrolizumab
    Participants received 200 mg pembrolizumab by IV infusion Q3W for up to 35 administrations, until centrally verified disease progression, or until a protocol-specified discontinuation criterion was met. Per investigator's discretion, eligible participants with stable disease, or partial/complete response who received a first course treatment may have received second course of treatment based on original randomization assignment for up to 17 cycles (up to \~1 year).

Primary Outcome Measure

Overall Survival (OS) in Participants With PD-L1 TPS ≥50% [ Time Frame: Up to ~39 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Boca Raton Regional Hospital ( Site 0004)Boca RatonFlorida33486-
Illinois Cancer Care ( Site 0026)PeoriaIllinois61615-
Mercy Research - Cancer and Hematology Center ( Site 0032)SpringfieldMissouri65804-
Mercy Research - David C. Pratt Cancer Center ( Site 0025)St LouisMissouri63141-
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)MineolaNew York11501-
Memorial Sloan Kettering Cancer Center ( Site 0013)New YorkNew York10065-
Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)PhiladelphiaPennsylvania19111-

Related coverage on Hipa.ai

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By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Boca Raton Regional Hospital· Boca Raton, FLIllinois Cancer Care· Peoria, ILMercy Research - Cancer and Hematology Center· Springfield, MOMercy Research - David C. Pratt Cancer Center· St Louis, MOPerlmutter Cancer Center at NYU Langone Hospital - Long Island· Mineola, NYMemorial Sloan Kettering Cancer Center· New York, NY

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