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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer

NCT04738487•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Detailed Description

The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 05-Sep-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 58 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
•Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
•Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
•Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
•Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
•Has a life expectancy of at least 3 months
•A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
•* Is not a woman of childbearing potential (WOCBP)
•* Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
•Has adequate organ function

Exclusion Criteria

•Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
•Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
•* Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
•* Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
•Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
•Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
•Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
•Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
•* Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
•* Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
+12 more criteria

Locations (188)

Boca Raton Regional Hospital ( Site 0004)

Boca Raton, Florida, United States

Illinois Cancer Care ( Site 0026)

Peoria, Illinois, United States

Mercy Research - Cancer and Hematology Center ( Site 0032)

Springfield, Missouri, United States

Mercy Research - David C. Pratt Cancer Center ( Site 0025)

St Louis, Missouri, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)

Mineola, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0013)

New York, New York, United States

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

Philadelphia, Pennsylvania, United States

Hospital São Carlos-Oncocentro Ce ( Site 0208)

Fortaleza, Ceará, Brazil

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)

Natal, Rio Grande do Norte, Brazil

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)

Ijuí, Rio Grande do Sul, Brazil

Key Dates

Start Date

April 7, 2021

Primary Completion Date

September 5, 2024

Completion Date

January 27, 2026

Last Updated

February 20, 2026

Enrollment

1,264

ACTUAL participants

Conditions

Lung NeoplasmsNon-Small-Cell Lung Carcinoma

Interventions

Pembrolizumab/Vibostolimab

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada

NCT07143110

Lung Neoplasms

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Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

NCT06885697

MesotheliomaNeoplasms+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

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