Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

NCT ID: NCT05224141

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2027-06-07

Brief Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Detailed Description

With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported.

Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.

Conditions

Small Cell Lung Carcinoma

Study Design

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

Study Groups

Pembrolizumab/Vibostolimab

Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Group Type: EXPERIMENTAL

Pembrolizumab/Vibostolimab Co-Formulation

Intervention Type: BIOLOGICAL

Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Saline placebo

Intervention Type: DRUG

Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Etoposide

Intervention Type: DRUG

Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Cisplatin

Intervention Type: DRUG

Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Atezolizumab

Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Group Type: ACTIVE_COMPARATOR

Saline placebo

Intervention Type: DRUG

Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Etoposide

Intervention Type: DRUG

Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Cisplatin

Intervention Type: DRUG

Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Atezolizumab

Intervention Type: BIOLOGICAL

Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Interventions

Pembrolizumab/Vibostolimab Co-Formulation

Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Intervention Type: BIOLOGICAL

Saline placebo

Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Intervention Type: DRUG

Etoposide

Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Intervention Type: DRUG

Cisplatin

Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Intervention Type: DRUG

Atezolizumab

Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Intervention Type: BIOLOGICAL

Carboplatin

Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Intervention Type: DRUG

Other Intervention Names

MK-7684A; PLATINOL-AQ®; TECENTRIQ®; PARAPLATIN®

Eligibility Criteria

Inclusion Criteria

• Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
• Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
• Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
• Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
• Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
• Has a predicted life expectancy of >3 months

Exclusion Criteria

• Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
• Has received prior treatment for Small Cell Lung Cancer (SCLC)
• Is expected to require any other form of antineoplastic therapy for SCLC while on study
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has a known history of, or active, neurologic paraneoplastic syndrome
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has had an allogenic tissue/solid organ transplant
• Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
• Has symptomatic ascites or pleural effusion

• 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

VA West Los Angeles Medical Center ( Site 0004)

Los Angeles, California, United States

Infirmary Cancer Care ( Site 0022)

Mobile, Alabama, United States

Los Angeles Hematology Oncology Medical Group ( Site 0006)

Los Angeles, California, United States

Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)

Boca Raton, Florida, United States

Fort Wayne Medical Oncology and Hematology ( Site 0013)

Fort Wayne, Indiana, United States

Dana-Farber Cancer Institute ( Site 0018)

Boston, Massachusetts, United States

Cancer and Hematology Centers of Western Michigan ( Site 0001)

Grand Rapids, Michigan, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0003)

Hattiesburg, Mississippi, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)

Lancaster, Pennsylvania, United States

Blue Ridge Cancer Care ( Site 0015)

Blacksburg, Virginia, United States

University of Virginia Cancer Center ( Site 0019)

Charlottesville, Virginia, United States

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

Mar del Plata, Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)

Buenos Aires, Buenos Aires F.D., Argentina

Hospital Provincial del Centenario ( Site 0205)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 0202)

Rosario, Santa Fe Province, Argentina

Nepean Hospital ( Site 2700)

Kingswood, New South Wales, Australia

Calvary Mater Newcastle ( Site 2703)

Waratah, New South Wales, Australia

Frankston Hospital-Oncology and Haematology ( Site 2702)

Frankston, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)

Melbourne, Victoria, Australia

Medizinische Universität Graz ( Site 0504)

Graz, Styria, Austria

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)

Linz, Upper Austria, Austria

Kepler Universitätsklinikum ( Site 0507)

Linz, Upper Austria, Austria

Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502)

Vienna, , Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)

Vienna, , Austria

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)

Kingston, Ontario, Canada

Lakeridge Health ( Site 0102)

Oshawa, Ontario, Canada

Anhui Cancer Hospital ( Site 2915)

Hefei, Anhui, China

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)

Beijing, Beijing Municipality, China

Beijing Peking Union Medical College Hospital ( Site 2921)

Beijing, Beijing Municipality, China

Fujian Provincial Cancer Hospital-oncology department ( Site 2904)

Fuzhou, Fujian, China

Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 2916)

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912)

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 2922)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 2907)

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University ( Site 2913)

Suzhou, Jiangsu, China

Jilin Cancer Hospital-GCP office ( Site 2909)

Changchun, Jilin, China

The First Hospital of Jilin University ( Site 2914)

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)

Xi'an, Shaanxi, China

Shanghai Chest Hospital-Oncology department ( Site 2900)

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center ( Site 2908)

Shanghai, Shanghai Municipality, China

Sichuan Cancer hospital. ( Site 2923)

Chengdu, Sichuan, China

West China Hospital Sichuan University ( Site 2903)

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Oncology ( Site 2919)

Hangzhou, Zhejiang, China

Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)

Oulu, North Ostrobothnia, Finland

Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)

Vaasa, Pohjanmaa, Finland

Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)

Turku, Southwest Finland, Finland

Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)

Marseille, Bouches-du-Rhone, France

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)

Toulouse, Haute-Garonne, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 0803)

Limoges, Haute-Vienne, France

Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)

Heidelberg, Baden-Wurttemberg, Germany

Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)

Immenhausen, Hesse, Germany

Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)

Hanover, Lower Saxony, Germany

LungenClinic Grosshansdorf-Onkologie ( Site 0903)

Großhansdorf, Schleswig-Holstein, Germany

SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)

Gera, Thuringia, Germany

Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)

Athens, Attica, Greece

Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)

Athens, Attica, Greece

Metropolitan Hospital ( Site 1001)

Athens, Attica, Greece

University General Hospital of Heraklion ( Site 1004)

Heraklion, Irakleio, Greece

European Interbalkan Medical Center ( Site 1000)

Thessaloniki, , Greece

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)

Kecskemét, Bács-Kiskun county, Hungary

Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)

Győr, Győr-Moson-Sopron, Hungary

Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)

Törökbálint, Pest County, Hungary

Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)

Kaposvár, Somogy County, Hungary

St. James's Hospital ( Site 1200)

Dublin, , Ireland

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)

Dublin, , Ireland

Rambam Health Care Campus-Oncology ( Site 1301)

Haifa, , Israel

Shaare Zedek Medical Center-Oncology ( Site 1300)

Jerusalem, , Israel

Sheba Medical Center-ONCOLOGY ( Site 1302)

Ramat Gan, , Israel

Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)

Naples, Campania, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

Milan, Lombardy, Italy

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)

Rozzano, Milano, Italy

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)

Rome, Roma, Italy

Aichi Cancer Center ( Site 3016)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 3002)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 3012)

Matsuyama, Ehime, Japan

Kurume University Hospital ( Site 3014)

Kurume, Fukuoka, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 3015)

Sapporo, Hokkaido, Japan

Kanazawa University Hospital ( Site 3006)

Kanazawa, Ishikawa-ken, Japan

Kanagawa Cancer Center ( Site 3004)

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital ( Site 3001)

Sendai, Miyagi, Japan

Niigata Cancer Center Hospital ( Site 3005)

Niigata, Niigata, Japan

Kansai Medical University Hospital ( Site 3009)

Hirakata, Osaka, Japan

Shizuoka Cancer Center ( Site 3007)

Nakatogari, Shizuoka, Japan

Cancer Institute Hospital of JFCR ( Site 3003)

Koto, Tokyo, Japan

National Hospital Organization Kyushu Medical Center ( Site 3013)

Fukuoka, , Japan

Okayama University Hospital ( Site 3011)

Okayama, , Japan

Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)

Klaipėda, Klaipedos Miestas, Lithuania

National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)

Vilnius, Vilniaus Miestas, Lithuania

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)

Kaunas, , Lithuania

Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)

Guadalajara, Jalisco, Mexico

Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)

Guadalajara, Jalisco, Mexico

Arké SMO S.A. de C.V. ( Site 0401)

Mexico City, Mexico City, Mexico

iCan Oncology Center Centro Medico AVE ( Site 0406)

Monterrey, Nuevo León, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0410)

Oaxaca City, , Mexico

Ziekenhuis Rijnstate ( Site 1606)

Arnhem, Gelderland, Netherlands

Maastricht UMC+-Pulmonary disease ( Site 1602)

Maastricht, Limburg, Netherlands

Jeroen Bosch Hospital-Pulmonology ( Site 1605)

's-Hertogenbosch, North Brabant, Netherlands

Isala, locatie Zwolle-Poli Longziekten ( Site 1612)

Zwolle, Overijssel, Netherlands

Medische Centrum Leeuwarden ( Site 1619)

Leeuwarden, Provincie Friesland, Netherlands

Erasmus Medisch Centrum ( Site 1621)

Rotterdam, South Holland, Netherlands

Martini Ziekenhuis ( Site 1618)

Groningen, , Netherlands

Przychodnia Lekarska KOMED ( Site 1701)

Konin, Greater Poland Voivodeship, Poland

Med-Polonia Sp. z o. o. ( Site 1710)

Poznan, Greater Poland Voivodeship, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)

Siedlce, Masovian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1700)

Warsaw, Masovian Voivodeship, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)

Przemyśl, Podkarpackie Voivodeship, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)

Prabuty, Pomeranian Voivodeship, Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)

Bystra, Silesian Voivodeship, Poland

Champalimaud Foundation ( Site 1812)

Lisbon, Lisbon District, Portugal

Hospital CUF Descobertas ( Site 1815)

Lisbon, Lisbon District, Portugal

Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)

Porto, , Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)

Porto, , Portugal

MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)

Bucharest, București, Romania

Centrul medical Focus ( Site 1903)

Bucharest, București, Romania

Cardiomed SRL Cluj-Napoca ( Site 1900)

Cluj-Napoca, Cluj, Romania

Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)

Craiova, Dolj, Romania

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901)

Craiova, Dolj, Romania

Cabinet Medical Oncomed ( Site 1902)

Timișoara, Timiș County, Romania

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)

Hwasun, Jeonranamdo, South Korea

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)

Deagu, Taegu-Kwangyokshi, South Korea

Chungnam national university hospital-Department of Internal Medicine ( Site 2802)

Daejeon, Taejon-Kwangyokshi, South Korea

Korea University Guro Hospital-Internal Medicine ( Site 2803)

Seoul, , South Korea

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)

Madrid, Madrid, Comunidad de, Spain

H.R.U Málaga - Hospital General-Oncology ( Site 2104)

Málaga, Malaga, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)

Barcelona, , Spain

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)

Seville, , Spain

Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)

Bornova, İzmir, Turkey (Türkiye)

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)

Adana, , Turkey (Türkiye)

Hacettepe Universitesi-oncology hospital ( Site 2409)

Ankara, , Turkey (Türkiye)

Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)

Ankara, , Turkey (Türkiye)

Ankara Bilkent City Hospital ( Site 2403)

Ankara, , Turkey (Türkiye)

Medipol University Medical Faculty-oncology ( Site 2400)

Istanbul, , Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)

Istanbul, , Turkey (Türkiye)

I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)

Izmir, , Turkey (Türkiye)

The Christie-Clinical Research Facility ( Site 2607)

Manchester, England, United Kingdom

Mount Vernon Hospital ( Site 2602)

Northwood, Hillingdon, United Kingdom

Heartlands Hospital-Oncology Research ( Site 2604)

Birmingham, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Canada; China; Finland; France; Germany; Greece; Hungary; Ireland; Israel; Italy; Japan; Lithuania; Mexico; Netherlands; Poland; Portugal; Romania; South Korea; Spain; 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 and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26261&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7684A-008

Identifier Type: OTHER

Identifier Source: secondary_id

KEYVIBE-008

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2021220008

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-503517-30-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1287-4436

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-005034-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7684A-008

Identifier Type: -

Identifier Source: org_study_id