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Coformulation of Pembrolizuma...

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)

Last Updated: 2025-08-26

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2026-01-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Neoplasms Non-Small-Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Pembrolizumab/Vibostolimab

Intervention Type 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

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).

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type BIOLOGICAL

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

Interventions

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Pembrolizumab/Vibostolimab

Intervention Type 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).

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-7684A MK-3475 Keytruda

Eligibility Criteria

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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.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
* Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Boca Raton Regional Hospital ( Site 0004)

Boca Raton, Florida, United States

Site Status

Illinois Cancer Care ( Site 0026)

Peoria, Illinois, United States

Site Status

Mercy Research - Cancer and Hematology Center ( Site 0032)

Springfield, Missouri, United States

Site Status

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

St Louis, Missouri, United States

Site Status

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

Mineola, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center ( Site 0013)

New York, New York, United States

Site Status

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

Philadelphia, Pennsylvania, United States

Site Status

Hospital São Carlos-Oncocentro Ce ( Site 0208)

Fortaleza, Ceará, Brazil

Site Status

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

Natal, Rio Grande do Norte, Brazil

Site Status

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

Ijuí, Rio Grande do Sul, Brazil

Site Status

Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)

Florianópolis, Santa Catarina, Brazil

Site Status

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)

Rio de Janeiro, , Brazil

Site Status

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)

São Paulo, , Brazil

Site Status

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)

São Paulo, , Brazil

Site Status

BC Cancer Victoria-Clinical Trials Unit ( Site 0107)

Victoria, British Columbia, Canada

Site Status

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)

Hamilton, Ontario, Canada

Site Status

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)

Kingston, Ontario, Canada

Site Status

Lakeridge Health ( Site 0106)

Oshawa, Ontario, Canada

Site Status

Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava

Laval, Quebec, Canada

Site Status

IC La Serena Research ( Site 0710)

La Serena, Coquimbo Region, Chile

Site Status

Clínica Puerto Montt ( Site 0713)

Port Montt, Los Lagos Region, Chile

Site Status

Oncocentro Valdivia ( Site 0715)

Valdivia, Los Ríos Region, Chile

Site Status

Clinica Universidad Catolica del Maule-Oncology ( Site 0703)

Talca, Maule Region, Chile

Site Status

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)

Santiago, Region M. de Santiago, Chile

Site Status

Orlandi Oncologia ( Site 0700)

Santiago, Region M. de Santiago, Chile

Site Status

FALP ( Site 0702)

Santiago, Region M. de Santiago, Chile

Site Status

Bradfordhill ( Site 0701)

Santiago, Region M. de Santiago, Chile

Site Status

James Lind Centro de Investigacion del Cancer ( Site 0711)

Temuco, Región de la Araucanía, Chile

Site Status

CIDO SpA-Oncology ( Site 0707)

Temuco, Región de la Araucanía, Chile

Site Status

Bradford Hill Norte ( Site 0708)

Antofagasta, , Chile

Site Status

The First Affiliated Hospital of Anhui Medical University ( Site 2022)

Hefei, Anhui, China

Site Status