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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)

NCT04738487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1264

Last updated 2026-02-20

Study results available
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Summary

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.

Conditions

  • Lung Neoplasms
  • Non-Small-Cell Lung Carcinoma

Interventions

BIOLOGICAL

Pembrolizumab/Vibostolimab

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).

BIOLOGICAL

Pembrolizumab

Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion every 3 weeks (Q3W) for up to 35 administrations (up to \~2 years).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2024-09-05
Completion
2026-01-27
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Chile
  • China
  • Dominican Republic
  • Guatemala
  • Hong Kong
  • Hungary
  • India
  • Japan
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738487 on ClinicalTrials.gov