Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

NCT ID: NCT05226598

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 739 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2026-01-09

Brief Summary

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

Detailed Description

Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from pembrolizumab plus chemotherapy, but unable to access it as SOC outside the study, may continue on study and receive treatment with pembrolizumab plus chemotherapy until discontinuation criteria are met.

Conditions

Metastatic Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MK-7684A + Chemotherapy

Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Group Type: EXPERIMENTAL

Pembrolizumab/Vibostolimab

Intervention Type: BIOLOGICAL

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations

Carboplatin

Intervention Type: DRUG

Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations

Cisplatin

Intervention Type: DRUG

Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations

Paclitaxel

Intervention Type: DRUG

Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations

Pemetrexed

Intervention Type: DRUG

Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

Pembrolizumab + Chemotherapy

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations

Cisplatin

Intervention Type: DRUG

Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations

Paclitaxel

Intervention Type: DRUG

Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations

Pemetrexed

Intervention Type: DRUG

Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

Pembrolizumab

Intervention Type: BIOLOGICAL

Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Interventions

Pembrolizumab/Vibostolimab

Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations

Intervention Type: BIOLOGICAL

Carboplatin

Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations

Intervention Type: DRUG

Cisplatin

Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations

Intervention Type: DRUG

Paclitaxel

Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations

Intervention Type: DRUG

Nab-paclitaxel

Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations

Intervention Type: DRUG

Pemetrexed

Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Intervention Type: BIOLOGICAL

Other Intervention Names

MK-7684A; PARAPLATIN®, Paraplatin NovaPlus ®; Platinol-AQ®; TAXOL®, ONXOL®; ABRAXANE®; Alimta®; MK-3475, KEYTRUDA®

Eligibility Criteria

Inclusion Criteria

• A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
• Has not received prior systemic treatment for metastatic NSCLC
• Has measurable disease based on RECIST 1.1, as determined by the local site assessment
• Has a life expectancy of at least 3 months
• Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method

Exclusion Criteria

• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
• 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 before the first dose of study medication
• Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus
• Received prior systemic anticancer therapy for metastatic disease
• Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
• History of allogeneic tissue/solid organ transplant
• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
• Is unable or unwilling to take folic acid or vitamin B12 supplementation
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

UCHealth Memorial Hospital-Heme Onc ( Site 0003)

Colorado Springs, Colorado, United States

University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)

Fort Collins, Colorado, United States

Mayo Clinic in Florida ( Site 0022)

Jacksonville, Florida, United States

Mount Sinai Hospital ( Site 0011)

Chicago, Illinois, United States

University of Chicago Medical Center ( Site 0015)

Chicago, Illinois, United States

New England Cancer Specialists ( Site 0008)

Scarborough, Maine, United States

Cancer and Hematology Centers of Western Michigan ( Site 0002)

Grand Rapids, Michigan, United States

Mayo Clinic in Rochester, Minnesota ( Site 0030)

Rochester, Minnesota, United States

Stony Brook University-Cancer Center ( Site 0013)

Stony Brook, New York, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)

Lancaster, Pennsylvania, United States

Charleston Oncology ( Site 0019)

Charleston, South Carolina, United States

University of Virginia Cancer Center ( Site 0018)

Charlottesville, Virginia, United States

Centro de Oncología e Investigación de Buenos Aires ( Site 0203)

Berazategui, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)

Mar del Plata, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)

ABB, Buenos Aires F.D., Argentina

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Parque ( Site 0205)

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario ( Site 0212)

Rosario, Santa Fe Province, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)

La Rioja, , Argentina

Medizinische Universität Graz ( Site 0704)

Graz, Styria, Austria

Medizinische Universitaet Innsbruck ( Site 0703)

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)

Linz, Upper Austria, Austria

Kepler Universitätsklinikum ( Site 0707)

Linz, Upper Austria, Austria

Klinik Penzing-2. Lungenabteilung ( Site 0702)

Vienna, Vienna, Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)

Vienna, , Austria

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)

Natal, Rio Grande do Norte, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)

Porto Alegre, Rio Grande do Sul, Brazil

Clínica de Oncologia Reichow ( Site 0407)

Blumenau, Santa Catarina, Brazil

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)

Rio de Janeiro, , Brazil

Hospital Paulistano ( Site 0401)

São Paulo, , Brazil

FALP-UIDO ( Site 0505)

Santiago, Region M. de Santiago, Chile

Centro de Oncología de Precisión ( Site 0515)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0510)

Santiago, Region M. de Santiago, Chile

James Lind Centro de Investigación del Cáncer ( Site 0502)

Temuco, Región de la Araucanía, Chile

CIDO SpA-Oncology ( Site 0508)

Temuco, Región de la Araucanía, Chile

ONCOCENTRO APYS-ACEREY ( Site 0503)

Viña del Mar, Región de Valparaíso, Chile

Biocenter ( Site 0514)

Concepción, Región del Biobío, Chile

Centro de Investigación Oncológica del Norte ( Site 0504)

Antofagasta, , Chile

Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)

Hefei, Anhui, China

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)

Beijing, Beijing Municipality, China

Fujian Provincial Cancer Hospital-oncology department ( Site 2621)

Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University ( Site 2626)

Xiamen, Fujian, China

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

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 2608)

Zhengzhou, Henan, China

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)

Wuhan, Hubei, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)

Wuhan, Hubei, China

Xiangya Hospital Central South University-Oncology department ( Site 2627)

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University ( Site 2623)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 2622)

Changsha, Hunan, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)

Nanchang, Jiangxi, China

Jilin Cancer Hospital-oncology department ( Site 2603)

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)

Xi'an, Shaanxi, China

Shandong Cancer Hospital-Oncology Department ( Site 2630)

Jinan, Shandong, China

Fudan University Shanghai Cancer Center ( Site 2616)

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)

Shanghai, Shanghai Municipality, China

Sichuan Cancer hospital ( Site 2628)

Chengdu, Sichuan, China

West China Hospital of Sichuan University ( Site 2610)

Chengdu, Sichuan, China

The Second People's Hospital of Yibin ( Site 2629)

Yibin, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Oncology ( Site 2612)

Hangzhou, Zhejiang, China

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

Hangzhou, Zhejiang, China

Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)

Medellín, Antioquia, Colombia

Administradora Country S.A. - Clinica del Country ( Site 0601)

Bogotá, Bogota D.C., Colombia

Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)

Valledupar, Cesar Department, Colombia

Oncomedica S.A.-Oncomedica S.A ( Site 0609)

Montería, Departamento de Córdoba, Colombia

Oncologos del Occidente ( Site 0608)

Pereira, Risaralda Department, Colombia

CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)

Orléans, Centre-Val de Loire, France

Centre Hospitalier d'Annecy ( Site 0807)

Epagny Metz-Tessy, Haute-Savoie, France

Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th

Lille, Hauts-de-France, France

Institut de Cancérologie de l'Ouest ( Site 0802)

Angers, Maine-et-Loire, France

CENTRE LEON BERARD ( Site 0803)

Lyon, Rhone, France

HIA Sainte Anne ( Site 0804)

Toulon, Var, France

Centre Hospitalier d'Avignon ( Site 0810)

Avignon, Vaucluse, France

UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)

Giessen, Hesse, Germany

GEFOS Gesellschaft f. onkologische Studien ( Site 0909)

Dortmund, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)

Lübeck, Schleswig-Holstein, Germany

SRH Wald-Klinikum Gera ( Site 0911)

Gera, Thuringia, Germany

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913

Berlin, , Germany

Rambam Health Care Campus-Oncology ( Site 1303)

Haifa, , Israel

Shaare Zedek Medical Center-Oncology ( Site 1306)

Jerusalem, , Israel

Meir Medical Center-oncology ( Site 1301)

Kfar Saba, , Israel

Sheba Medical Center-ONCOLOGY ( Site 1302)

Ramat Gan, , Israel

Sourasky Medical Center-Oncology ( Site 1305)

Tel Aviv, , Israel

National Hospital Organization Shikoku Cancer Center ( Site 2414)

Matsuyama, Ehime, Japan

Ehime University Hospital ( Site 2411)

Tōon, Ehime, Japan

Hyogo Cancer Center-Thoracic Oncology ( Site 2409)

Akashi, Hyōgo, Japan

Kanazawa University Hospital ( Site 2407)

Kanazawa, Ishikawa-ken, Japan

Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)

Yokohama, Kanagawa, Japan

Miyagi Cancer Center ( Site 2401)

Natori-shi, Miyagi, Japan

Kansai Medical University Hospital ( Site 2415)

Hirakata, Osaka, Japan

Saitama Prefectural Cancer Center ( Site 2406)

Ina-machi, Saitama, Japan

Shizuoka Cancer Center ( Site 2408)

Nakatogari, Shizuoka, Japan

Japanese Foundation for Cancer Research ( Site 2402)

Koto, Tokyo, Japan

Showa University Hospital ( Site 2403)

Shinagawa, Tokyo, Japan

National Hospital Organization Kyushu Medical Center ( Site 2413)

Fukuoka, , Japan

National Hospital Organization Kyushu Cancer Center ( Site 2412)

Fukuoka, , Japan

Okayama University Hospital ( Site 2410)

Okayama, , Japan

Nippon Medical School Hospital ( Site 2404)

Tokyo, , Japan

CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)

Saltillo, Coahuila, Mexico

Hospital Civil Fray Antonio Alcalde ( Site 0307)

Guadalajara, Jalisco, Mexico

Arké SMO S.A. de C.V. ( Site 0301)

Mexico City, Mexico City, Mexico

Alivia Clínica de Alta Especialidad ( Site 0310)

Mexico City, Mexico City, Mexico

Przychodnia Lekarska KOMED ( Site 1902)

Konin, Greater Poland Voivodeship, Poland

Med-Polonia Sp. z o. o. ( Site 1909)

Poznan, Greater Poland Voivodeship, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)

Warsaw, Masovian Voivodeship, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)

Przemyśl, Podkarpackie Voivodeship, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)

Prabuty, Pomeranian Voivodeship, Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)

Bystra, Silesian Voivodeship, Poland

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)

Hwasun, Jeonranamdo, South Korea

Pusan National University Hospital ( Site 2205)

Busan, Pusan-Kwangyokshi, South Korea

Asan Medical Center ( Site 2206)

Songpa-gu, Seoul, South Korea

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)

Deagu, Taegu-Kwangyokshi, South Korea

Chungnam national university hospital-Department of Internal Medicine ( Site 2203)

Daejeon, Taejon-Kwangyokshi, South Korea

Korea University Guro Hospital-Internal Medicine ( Site 2204)

Seoul, , South Korea

CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)

A Coruña, La Coruna, Spain

Hospital Insular de Gran Canaria-Oncology ( Site 1102)

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)

Barcelona, , Spain

Hospital Clinico San Carlos-Oncology Department ( Site 1107)

Madrid, , Spain

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)

Seville, , Spain

Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)

Zaragoza, , Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)

Kaohsiung City, , Taiwan

China Medical University Hospital ( Site 2253)

Taichung, , Taiwan

NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)

Tainan, , Taiwan

National Taiwan University Hospital-Oncology ( Site 2255)

Taipei, , Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 2251)

Taoyuan District, , Taiwan

Faculty of Medicine Siriraj Hospital ( Site 2304)

Bangkok, Bangkok, Thailand

Chulabhorn Hospital ( Site 2305)

Lak Si, Bangkok, Thailand

Faculty of Medicine - Khon Kaen University ( Site 2303)

Muang, Changwat Khon Kaen, Thailand

Songklanagarind hospital ( Site 2302)

Hat Yai, Changwat Songkhla, Thailand

Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)

Chiang Mai, , Thailand

Acibadem Altunizade Hospital-Oncology ( Site 1207)

Üsküdar / Stanbul, Istanbul, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)

Adana, , Turkey (Türkiye)

Hacettepe Universitesi-oncology hospital ( Site 1202)

Ankara, , Turkey (Türkiye)

Liv Hospital Ankara-Oncology ( Site 1205)

Ankara, , Turkey (Türkiye)

Ankara City Hospital ( Site 1204)

Ankara, , Turkey (Türkiye)

Trakya University-Medical Oncology ( Site 1203)

Edirne, , Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)

Istanbul, , Turkey (Türkiye)

Umraniye Training and Research Hospital-medical oncology ( Site 1206)

Istanbul, , Turkey (Türkiye)

Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)

Leicester, England, United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)

London, England, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)

London, London, City of, United Kingdom

University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)

London-Camden, London, City of, United Kingdom

Countries

United States; Argentina; Austria; Brazil; Chile; China; Colombia; France; Germany; Israel; Japan; Mexico; Poland; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

Shapira-Frommer R, Niu J, Perets R, Peters S, Shouse G, Lugowska I, Garassino MC, Sands J, Keenan T, Zhao B, Healy J, Ahn MJ. The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies. Future Oncol. 2024;20(27):1983-1991. doi: 10.1080/14796694.2024.2343272. Epub 2024 Sep 4.

Reference Type: DERIVED

PMID: 39230120 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26241&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7684A-007

Identifier Type: OTHER

Identifier Source: secondary_id

KEYVIBE-007

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031220098

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506074-12-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1293-2114

Identifier Type: REGISTRY

Identifier Source: secondary_id

7684A-007

Identifier Type: -

Identifier Source: org_study_id