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COMPLETED Phase 3

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL Pembrolizumab/Vibostolimab

Study Locations (20)

Other

  • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204) — Rio de Janeiro
  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200) — São Paulo
  • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207) — São Paulo

Ontario

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104) — Hamilton
  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102) — Kingston
  • Lakeridge Health ( Site 0106) — Oshawa

Missouri

  • Mercy Research - Cancer and Hematology Center ( Site 0032) — Springfield
  • Mercy Research - David C. Pratt Cancer Center ( Site 0025) — St Louis

New York

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022) — Mineola
  • Memorial Sloan Kettering Cancer Center ( Site 0013) — New York

Rio Grande do Sul

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206) — Ijuí
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân — Porto Alegre

Florida

  • Boca Raton Regional Hospital ( Site 0004) — Boca Raton

Illinois

  • Illinois Cancer Care ( Site 0026) — Peoria

Pennsylvania

  • Fox Chase Cancer Center-Hematology/Oncology ( Site 0030) — Philadelphia

Trial Details

FieldValue
Enrollment Target 1,264 participants
Start Date 2021-04-07
Est. Completion 2026-01-27
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04738487

The ClinicalTrials.gov registry entry for NCT04738487 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Lung Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04738487 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Ontario, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04738487 about?

NCT04738487 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT04738487?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,264 participants. The study started on 2021-04-07. Estimated completion is 2026-01-27.

What conditions does trial NCT04738487 study?

This clinical trial studies the following conditions: Lung Neoplasms, Non-Small-Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04738487?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Pembrolizumab/Vibostolimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04738487?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04738487 being conducted?

This trial has 20 study locations across Florida, Illinois, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial