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)

NCT05224141 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 7 other identifiers: 7684A-008MK-7684A-008KEYVIBE-008jRCT20212200082023-503517-30-00U1111-1287-44362021-005034-42
• Study Type: interventional
• Target: 460
• Locations: 24 countries
• Sites: 135

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.

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.

  Up to approximately 25 months

Secondary Outcomes (15)

• Progression-Free Survival (PFS)

  Up to approximately 25 months

• Objective Response Rate (ORR)

  Up to approximately 25 months

• Duration of Response (DOR)

  Up to approximately 25 months

• Percentage of Participants Who Experienced an Adverse Event (AE)

  Up to approximately 60 months

• Percentage of Participants Who Discontinued Study Treatment Due to an AE

  Up to approximately 60 months

Study Arms (2)

Pembrolizumab/Vibostolimab

EXPERIMENTAL

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.

Biological: Pembrolizumab/Vibostolimab Co-Formulation; Drug: Saline placebo; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin

Atezolizumab

ACTIVE COMPARATOR

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.

Drug: Saline placebo; Drug: Etoposide; Drug: Cisplatin; Biological: Atezolizumab; Drug: Carboplatin

Interventions

Pembrolizumab/Vibostolimab Co-Formulation 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.

Also known as: MK-7684A

Pembrolizumab/Vibostolimab

Saline placebo DRUG

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

Atezolizumab; Pembrolizumab/Vibostolimab

Etoposide DRUG

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

Atezolizumab; Pembrolizumab/Vibostolimab

Cisplatin DRUG

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

Also known as: PLATINOL-AQ®

Atezolizumab; Pembrolizumab/Vibostolimab

Atezolizumab BIOLOGICAL

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

Also known as: TECENTRIQ®

Atezolizumab

Carboplatin DRUG

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

Also known as: PARAPLATIN®

Atezolizumab; Pembrolizumab/Vibostolimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (140)

Infirmary Cancer Care ( Site 0022)

Mobile, Alabama, 36607, United States

Location

Los Angeles Hematology Oncology Medical Group ( Site 0006)

Los Angeles, California, 90017, United States

Location

VA West Los Angeles Medical Center ( Site 0004)

Los Angeles, California, 90073, United States

Location

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

Boca Raton, Florida, 33486, United States

Location

Fort Wayne Medical Oncology and Hematology ( Site 0013)

Fort Wayne, Indiana, 46804, United States

Location

Dana-Farber Cancer Institute ( Site 0018)

Boston, Massachusetts, 02215, United States

Location

Cancer and Hematology Centers of Western Michigan ( Site 0001)

Grand Rapids, Michigan, 49503, United States

Location

Hattiesburg Clinic Hematology/Oncology ( Site 0003)

Hattiesburg, Mississippi, 39401, United States

Location

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

Lancaster, Pennsylvania, 17601, United States

Location

Blue Ridge Cancer Care ( Site 0015)

Blacksburg, Virginia, 24060, United States

Location

University of Virginia Cancer Center ( Site 0019)

Charlottesville, Virginia, 22903, United States

Location

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

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

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

Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina

Location

Hospital Provincial del Centenario ( Site 0205)

Rosario, Santa Fe Province, 2002, Argentina

Location

Sanatorio Parque ( Site 0202)

Rosario, Santa Fe Province, S2000DVC, Argentina

Location

Nepean Hospital ( Site 2700)

Kingswood, New South Wales, 2747, Australia

Location

Calvary Mater Newcastle ( Site 2703)

Waratah, New South Wales, 2298, Australia

Location

Frankston Hospital-Oncology and Haematology ( Site 2702)

Frankston, Victoria, 3199, Australia

Location

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

Melbourne, Victoria, 3021, Australia

Location

Medizinische Universität Graz ( Site 0504)

Graz, Styria, 8036, Austria

Location

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

Linz, Upper Austria, 4020, Austria

Location

Kepler Universitätsklinikum ( Site 0507)

Linz, Upper Austria, 4021, Austria

Location

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

Vienna, 1140, Austria

Location

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

Vienna, 1210, Austria

Location

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

Kingston, Ontario, K7L 2V7, Canada

Location

Lakeridge Health ( Site 0102)

Oshawa, Ontario, L1G 2B9, Canada

Location

Anhui Cancer Hospital ( Site 2915)

Hefei, Anhui, 230031, China

Location

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

Beijing, Beijing Municipality, 100142, China

Location

Beijing Peking Union Medical College Hospital ( Site 2921)

Beijing, Beijing Municipality, 100730, China

Location

Fujian Provincial Cancer Hospital-oncology department ( Site 2904)

Fuzhou, Fujian, 350014, China

Location

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

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital ( Site 2916)

Zhengzhou, Henan, 450008, China

Location

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

Wuhan, Hubei, 430048, China

Location

Hubei Cancer Hospital ( Site 2922)

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital ( Site 2907)

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Soochow University ( Site 2913)

Suzhou, Jiangsu, 215006, China

Location

Jilin Cancer Hospital-GCP office ( Site 2909)

Changchun, Jilin, 130000, China

Location

The First Hospital of Jilin University ( Site 2914)

Changchun, Jilin, 130021, China

Location

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

Xi'an, Shaanxi, 710061, China

Location

Shanghai Chest Hospital-Oncology department ( Site 2900)

Shanghai, Shanghai Municipality, 200030, China

Location

Fudan University Shanghai Cancer Center ( Site 2908)

Shanghai, Shanghai Municipality, 200032, China

Location

Sichuan Cancer hospital. ( Site 2923)

Chengdu, Sichuan, 610042, China

Location

West China Hospital Sichuan University ( Site 2903)

Chengdu, Sichuan, 611135, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital-Oncology ( Site 2919)

Hangzhou, Zhejiang, 310022, China

Location

Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)

Oulu, North Ostrobothnia, 90220, Finland

Location

Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)

Vaasa, Pohjanmaa, 65130, Finland

Location

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

Turku, Southwest Finland, 20520, Finland

Location

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

Marseille, Bouches-du-Rhone, 13915, France

Location

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

Toulouse, Haute-Garonne, 31400, France

Location

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

Limoges, Haute-Vienne, 87042, France

Location

Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)

Immenhausen, Hesse, 34376, Germany

Location

Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)

Hanover, Lower Saxony, 30625, Germany

Location

LungenClinic Grosshansdorf-Onkologie ( Site 0903)

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)

Gera, Thuringia, 07548, Germany

Location

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

Athens, Attica, 115 26, Greece

Location

Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)

Athens, Attica, 11527, Greece

Location

Metropolitan Hospital ( Site 1001)

Athens, Attica, 185 47, Greece

Location

University General Hospital of Heraklion ( Site 1004)

Heraklion, Irakleio, 71500, Greece

Location

European Interbalkan Medical Center ( Site 1000)

Thessaloniki, 570 01, Greece

Location

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

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

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

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)

Törökbálint, Pest County, 2045, Hungary

Location

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

Kaposvár, Somogy County, 7400, Hungary

Location

St. James's Hospital ( Site 1200)

Dublin, D08 E9P6, Ireland

Location

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

Dublin, Dublin 9, Ireland

Location

Rambam Health Care Campus-Oncology ( Site 1301)

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center-Oncology ( Site 1300)

Jerusalem, 9103102, Israel

Location

Sheba Medical Center-ONCOLOGY ( Site 1302)

Ramat Gan, 5265601, Israel

Location

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

Naples, Campania, 80131, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)

Milan, Lombardy, 20133, Italy

Location

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

Rozzano, Milano, 20089, Italy

Location

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

Rome, Roma, 00144, Italy

Location

Aichi Cancer Center ( Site 3016)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 3002)

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 3012)

Matsuyama, Ehime, 791-0280, Japan

Location

Kurume University Hospital ( Site 3014)

Kurume, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Hokkaido Cancer Center ( Site 3015)

Sapporo, Hokkaido, 003-0804, Japan

Location

Kanazawa University Hospital ( Site 3006)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kanagawa Cancer Center ( Site 3004)

Yokohama, Kanagawa, 241-8515, Japan

Location

Sendai Kousei Hospital ( Site 3001)

Sendai, Miyagi, 981-0914, Japan

Location

Niigata Cancer Center Hospital ( Site 3005)

Niigata, Niigata, 951-8566, Japan

Location

Kansai Medical University Hospital ( Site 3009)

Hirakata, Osaka, 573-1191, Japan

Location

Shizuoka Cancer Center ( Site 3007)

Nakatogari, Shizuoka, 411-8777, Japan

Location

Cancer Institute Hospital of JFCR ( Site 3003)

Koto, Tokyo, 135-8550, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 3013)

Fukuoka, 810-8563, Japan

Location

Okayama University Hospital ( Site 3011)

Okayama, 700-8558, Japan

Location

Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)

Klaipėda, Klaipedos Miestas, 92288, Lithuania

Location

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

Vilnius, Vilniaus Miestas, 08660, Lithuania

Location

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

Kaunas, LT-50161, Lithuania

Location

Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)

Guadalajara, Jalisco, 44280, Mexico

Location

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

Guadalajara, Jalisco, 44680, Mexico

Location

Arké SMO S.A. de C.V. ( Site 0401)

Mexico City, Mexico City, 06700, Mexico

Location

iCan Oncology Center Centro Medico AVE ( Site 0406)

Monterrey, Nuevo León, 64710, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 0410)

Oaxaca City, 68020, Mexico

Location

Ziekenhuis Rijnstate ( Site 1606)

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Maastricht UMC+-Pulmonary disease ( Site 1602)

Maastricht, Limburg, 6229 HX, Netherlands

Location

Jeroen Bosch Hospital-Pulmonology ( Site 1605)

's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

Location

Isala, locatie Zwolle-Poli Longziekten ( Site 1612)

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Medische Centrum Leeuwarden ( Site 1619)

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Erasmus Medisch Centrum ( Site 1621)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Martini Ziekenhuis ( Site 1618)

Groningen, 9728 NT, Netherlands

Location

Przychodnia Lekarska KOMED ( Site 1701)

Konin, Greater Poland Voivodeship, 62-500, Poland

Location

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

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

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

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

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

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

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

Prabuty, Pomeranian Voivodeship, 82-550, Poland

Location

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)

Bystra, Silesian Voivodeship, 43-360, Poland

Location

Champalimaud Foundation ( Site 1812)

Lisbon, Lisbon District, 1400-038, Portugal

Location

Hospital CUF Descobertas ( Site 1815)

Lisbon, Lisbon District, 1998-018, Portugal

Location

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

Porto, 4099-001, Portugal

Location

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

Porto, 4200-072, Portugal

Location

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

Bucharest, București, 022343, Romania

Location

Centrul medical Focus ( Site 1903)

Bucharest, București, 022548, Romania

Location

Cardiomed SRL Cluj-Napoca ( Site 1900)

Cluj-Napoca, Cluj, 400015, Romania

Location

Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)

Craiova, Dolj, 200385, Romania

Location

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1901)

Craiova, Dolj, 200746, Romania

Location

Cabinet Medical Oncomed ( Site 1902)

Timișoara, Timiș County, 300239, Romania

Location

Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)

Hwasun, Jeonranamdo, 58128, South Korea

Location

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)

Deagu, Taegu-Kwangyokshi, 41404, South Korea

Location

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

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

Location

Korea University Guro Hospital-Internal Medicine ( Site 2803)

Seoul, South Korea

Location

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

Madrid, Madrid, Comunidad de, 28041, Spain

Location

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

Málaga, Malaga, 29011, Spain

Location

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

Barcelona, 08035, Spain

Location

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

Seville, 41009, Spain

Location

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

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

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

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Universitesi-oncology hospital ( Site 2409)

Ankara, 06230, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)

Ankara, 06520, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital ( Site 2403)

Ankara, 06800, Turkey (Türkiye)

Location

Medipol University Medical Faculty-oncology ( Site 2400)

Istanbul, 34214, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

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

Izmir, 35575, Turkey (Türkiye)

Location

The Christie-Clinical Research Facility ( Site 2607)

Manchester, England, M20 4BX, United Kingdom

Location

Mount Vernon Hospital ( Site 2602)

Northwood, Hillingdon, HA6 2RN, United Kingdom

Location

Heartlands Hospital-Oncology Research ( Site 2604)

Birmingham, B9 5SS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39230120 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

pembrolizumab; Etoposide; Cisplatin; atezolizumab; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: March 24, 2022
• Primary Completion: June 4, 2024
• Study Completion (Estimated): June 7, 2027
• Last Updated: July 8, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

HU (4); IE (2); JP (14); LI (3); PL (7); PT (4); TU (8); GB (3); ES (4); FR (3); DE (5); RO (6); AU (4); AR (5); KR (4); IT (4); ME (5); NL (7); FI (3); IL (3); US (11); CN (19); CA (2); GR (5)