NCT04738487|CompletedPhase 3ResultsDMCFDA Drug

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

Merck Sharp & Dohme LLC ClinicalTrials.gov

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8 other identifiers

7684A-003MK-7684A-003jRCT2021210025KEYVIBE-003PHRR230831-0060542023-505362-28-00U1111-1291-55522020-004049-35

Study Type

interventional

Target

1,264

Locations

23 countries

Sites

188

Timeline

RegisteredFeb 2021

StartedApr 2021

CompletionJan 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,264

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2021

Longer than P75 for phase_3

Geographic Reach

23 countries

188 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.8 years study duration

First Submitted

Initial submission to the registry

February 2, 2021

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2024

Completed

12 months until next milestone

Results Posted

Study results publicly available

August 26, 2025

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2026

Completed

Last Updated

February 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

February 2, 2021

Results QC Date

July 28, 2025

Last Update Submit

February 3, 2026

Conditions

Lung Neoplasms Non-Small-Cell Lung Carcinoma

Keywords

Programmed Cell Death-1 (PD1, PD-1)Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS) in Participants With PD-L1 TPS ≥50%
OS was defined as the time from randomization to death due to any cause.
Up to ~39 months

Secondary Outcomes (49)

OS in Participants With PD-L1 TPS ≥1%
Up to ~39 months
OS in Participants With PD-L1 TPS 1% to 49%
Up to ~39 months
Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
Up to ~56 months
PFS in Participants With PD-L1 TPS ≥50%
Up to ~56 months
PFS in Participants With PD-L1 TPS 1% to 49%
Up to ~56 months
+44 more secondary outcomes

Study Arms (2)

Pembrolizumab/Vibostolimab

EXPERIMENTAL

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).

Biological: Pembrolizumab/Vibostolimab

Pembrolizumab

ACTIVE COMPARATOR

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).

Biological: Pembrolizumab

Interventions

PembrolizumabBIOLOGICAL

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

Also known as: MK-3475, Keytruda

Pembrolizumab

Pembrolizumab/VibostolimabBIOLOGICAL

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).

Also known as: MK-7684A

Pembrolizumab/Vibostolimab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Merck Sharp & Dohme LLClead

Study Sites (188)

Boca Raton Regional Hospital ( Site 0004)

Boca Raton, Florida, 33486, United States

Location

Illinois Cancer Care ( Site 0026)

Peoria, Illinois, 61615, United States

Location

Mercy Research - Cancer and Hematology Center ( Site 0032)

Springfield, Missouri, 65804, United States

Location

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

St Louis, Missouri, 63141, United States

Location

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

Mineola, New York, 11501, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0013)

New York, New York, 10065, United States

Location

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

Philadelphia, Pennsylvania, 19111, United States

Location

Hospital São Carlos-Oncocentro Ce ( Site 0208)

Fortaleza, Ceará, 60135-237, Brazil

Location

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

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

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

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

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

Florianópolis, Santa Catarina, 88020-210, Brazil

Location

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

Rio de Janeiro, 20231-050, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

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

São Paulo, 04014-002, Brazil

Location

BC Cancer Victoria-Clinical Trials Unit ( Site 0107)

Victoria, British Columbia, V8R 6V5, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)

Hamilton, Ontario, L8V 5C2, Canada

Location

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

Kingston, Ontario, K7L 2V7, Canada

Location

Lakeridge Health ( Site 0106)

Oshawa, Ontario, L1G 2B9, Canada

Location

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

Laval, Quebec, H7M 3L9, Canada

Location

IC La Serena Research ( Site 0710)

La Serena, Coquimbo Region, 1720430, Chile

Location

Clínica Puerto Montt ( Site 0713)

Port Montt, Los Lagos Region, 5500243, Chile

Location

Oncocentro Valdivia ( Site 0715)

Valdivia, Los Ríos Region, 5112129, Chile

Location

Clinica Universidad Catolica del Maule-Oncology ( Site 0703)

Talca, Maule Region, 3465584, Chile

Location

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)

Santiago, Region M. de Santiago, 7500653, Chile

Location

Orlandi Oncologia ( Site 0700)

Santiago, Region M. de Santiago, 7500713, Chile

Location

FALP ( Site 0702)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Bradfordhill ( Site 0701)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigacion del Cancer ( Site 0711)

Temuco, Región de la Araucanía, 4800827, Chile

Location

CIDO SpA-Oncology ( Site 0707)

Temuco, Región de la Araucanía, 4810218, Chile

Location

Bradford Hill Norte ( Site 0708)

Antofagasta, 1240000, Chile

Location

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

Hefei, Anhui, 230000, China

Location

Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)

Hefei, Anhui, 230036, China

Location

Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)

Beijing, Beijing Municipality, 100142, China

Location

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)

Beijing, Beijing Municipality, 100142, China

Location

Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)

Beijing, Beijing Municipality, 100730, China

Location

Beijing Chest Hospital,Capital Medical University ( Site 2020)

Beijing, Beijing Municipality, 101149, China

Location

Chongqing Cancer Hospital-Medical Oncology ( Site 2028)

Chongqing, Chongqing Municipality, 400030, China

Location

Army Medical Center of People's Liberation Army-respiratory ( Site 2025)

Chongqing, Chongqing Municipality, 400042, China

Location

Fujian Provincial Cancer Hospital-oncology department ( Site 2023)

Fuzhou, Fujian, 350014, China

Location

Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)

Fuzhou, Fujian, 350025, China

Location

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

Guangzhou, Guangdong, 510515, China

Location

Harbin Medical University Cancer Hospital ( Site 2006)

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital ( Site 2015)

Zhengzhou, Henan, 450008, China

Location

Wuhan Union Hospital-Medical Oncology ( Site 2019)

Wuhan, Hubei, 430010, China

Location

Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital-thoracic oncology II ( Site 2013)

Changsha, Hunan, 410013, China

Location

Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)

Yangzhou, Jiangsu, 225001, China

Location

Jilin Cancer Hospital-oncology department ( Site 2000)

Changchun, Jilin, 132000, China

Location

Tang Du Hospital ( Site 2004)

Xi'an, Shaanxi, 710038, China

Location

The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)

Xi'an, Shaanxi, 710061, China

Location

LinYi Cancer Hospital ( Site 2034)

Linyi, Shandong, 276001, China

Location

Linyi People's Hospital-Oncology ( Site 2035)

Linyi, Shandong, China

Location

Fudan University Shanghai Cancer Center ( Site 2032)

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital Sichuan University-respiratory ( Site 2018)

Chengdu, Sichuan, 610041, China

Location

Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)

Hangzhou, Zhejiang, 310002, China

Location

Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)

Hangzhou, Zhejiang, 310022, China

Location

The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site

Hangzhou, Zhejiang, 310052, China

Location

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)

Linhai, Zhejiang, 317000, China

Location

The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)

Wenzhou, Zhejiang, 325015, China

Location

Instituto de Oncologia ( Site 2300)

Santo Domingo, Nacional, 10102, Dominican Republic

Location

CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)

Santo Domingo, Nacional, 10104, Dominican Republic

Location

CELAN,S.A ( Site 0304)