Lung Cancer Clinical Trial

Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

Summary

The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

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Full Description

Participants may receive additional 17 cycles of pembrolizumab/vibostolimab (each cycle length = 21 days) for an additional 1 year of treatment as second course phase at investigator's discretion.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) 1 directed therapy is not indicated as primary therapy

Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies

Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease
Has measurable disease defined as at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Has a life expectancy of at least 3 months
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days prior to randomization
Male participants randomized to docetaxel are eligible to participant if they agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) must agree to follow contraceptive guidance as per study protocol unless confirmed to be azoospermic during the intervention period and for at least 180 days after the last dose of docetaxel
Female participants must be not pregnant, not breastfeeding, and not be a woman of child-bearing potential (WOCBP). A WOCBP is eligible is she agrees to either use contraception, or be abstinent from heterosexual intercourse during the intervention period and for ≥120 days after the last dose of study intervention. If a WOCBP is randomized to docetaxel, she agrees not to donate eggs and either uses contraception or be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of docetaxel
Has adequate organ function

Exclusion Criteria:

Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
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 docetaxel as monotherapy or in combination with other therapies
Has received previous treatment with another agent targeting the T-cell immunoreceptor with immunoglobulin [Ig] and immunoreceptor tyrosine-based inhibitory motif [ITIM] domains (TIGIT) pathway
Has received radiotherapy within 2 weeks of start of study intervention. One week washout is permitted for palliative radiation to non-CNS disease
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is 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
Has severe hypersensitivity (≥Grade 3) to docetaxel or pembrolizumab/vibostolimab coformulation and/or any of its excipients Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
Has interstitial lung disease, or history of pneumonitis requiring steroids for treatment
Has known history of active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
Has had an allogenic tissue/solid organ transplant
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

240

Study ID:

NCT04725188

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 94 Locations for this study

See Locations Near You

Cedars-Sinai Medical Center ( Site 2522)
Los Angeles California, 90048, United States
Illinois Cancer Care ( Site 2534)
Peoria Illinois, 61615, United States
Baptist Health Lexington-Research ( Site 2502)
Lexington Kentucky, 40503, United States
University of Maryland ( Site 2528)
Baltimore Maryland, 21201, United States
Hattiesburg Clinic Hematology/Oncology ( Site 2511)
Hattiesburg Mississippi, 39401, United States
Mercy Research - David C. Pratt Cancer Center ( Site 2532)
Saint Louis Missouri, 63109, United States
Mercy Research - Cancer and Hematology Center ( Site 2535)
Springfield Missouri, 65804, United States
Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)
Bronx New York, 10461, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)
Cincinnati Ohio, 45219, United States
St Francis Cancer Center-Research Office ( Site 2531)
Greenville South Carolina, 29607, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0008)
Berazategui Buenos Aires, B1884, Argentina
Hospital Privado de Comunidad ( Site 0004)
Mar del Plata Buenos Aires, 7600, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)
Mar del Plata Buenos Aires, 7600, Argentina
Instituto de Oncología de Rosario ( Site 0003)
Rosario Santa Fe, S2000, Argentina
Hospital Privado Universitario de Córdoba ( Site 0001)
Cordoba , 5016, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)
La Rioja , F5300, Argentina
Canberra Hospital ( Site 0104)
Canberra Australian Capital Territory, 2605, Australia
Gold Coast University Hospital-Clinical Trials Service ( Site 0106)
Southport Queensland, 4215, Australia
Fiona Stanley Hospital-Medical Oncology ( Site 0102)
Murdoch Western Australia, 6150, Australia
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)
Linz Oberosterreich, 4020, Austria
Medizinische Universität Graz ( Site 0201)
Graz Steiermark, 8036, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)
Wien , 1210, Austria
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)
Mechelen Antwerpen, 2800, Belgium
UZ Brussel ( Site 0336)
Brussels Bruxelles-Capitale, Region De, 1090, Belgium
Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)
Charleroi Hainaut, 6000, Belgium
Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)
Hasselt Limburg, 3500, Belgium
AZ Nikolaas ( Site 0334)
Sint-Niklaas Oost-Vlaanderen, 1932, Belgium
Hospital Nossa Senhora da Conceição ( Site 0403)
Porto Alegre Rio Grande Do Sul, 91350, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)
São Paulo Sao Paulo, 01246, Brazil
Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)
Rio de Janeiro , 22250, Brazil
Hospital Paulistano ( Site 0406)
Sao Paulo , 01321, Brazil
Rigshospitalet ( Site 0702)
Copenhagen Hovedstaden, 2100, Denmark
Odense Universitetshospital ( Site 0700)
Odense Syddanmark, 5000, Denmark
Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)
Soenderborg Syddanmark, 6400, Denmark
Tampereen yliopistollinen sairaala-Oncology ( Site 0906)
Tampere Pirkanmaa, 33520, Finland
Vaasan Keskussairaala ( Site 0903)
Vaasa Pohjanmaa, 65130, Finland
Oulun yliopistollinen sairaala ( Site 0902)
Oulu Pohjois-Pohjanmaa, 90220, Finland
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)
Turku Varsinais-Suomi, 20520, Finland
Nouvel Hôpital Civil (NHC) ( Site 1000)
Strasbourg Alsace, 67000, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)
Bordeaux Aquitaine, 33000, France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)
Caen Calvados, 14033, France
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)
Toulouse Haute-Garonne, 31059, France
Clinique Ambroise Paré ( Site 1007)
Beuvry Pas-de-Calais, 62660, France
Centre Hospitalier du Mans ( Site 1002)
Le Mans Sarthe, 72037, France
Gustave Roussy ( Site 1005)
Villejuif Val-de-Marne, 94800, France
HIA Sainte Anne ( Site 1003)
Toulon Var, 83800, France
Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)
Avignon Vaucluse, 84000, France
Onkologie Ravensburg ( Site 1104)
Ravensburg Baden-Wurttemberg, 88212, Germany
Klinikverbund Allgaeu gGmbH ( Site 1109)
Immenstadt im Allgäu Bayern, 87509, Germany
Helios Dr. Horst Schmidt Kliniken ( Site 1108)
Wiesbaden Hessen, 65199, Germany
Universitätsklinikum Bonn ( Site 1111)
Bonn Nordrhein-Westfalen, 53127, Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)
Berlin , 14165, Germany
Soroka Medical Center ( Site 1202)
Be'er Sheva , 84101, Israel
Rambam Health Care Campus-Oncology ( Site 1203)
Haifa , 31096, Israel
Shaare Zedek Medical Center-Oncology ( Site 1206)
Jerusalem , 91031, Israel
Sourasky Medical Center ( Site 1205)
Tel Aviv , 64239, Israel
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)
Roma Lazio, 00184, Italy
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)
Naples Napoli, 80131, Italy
CRO-IRCCS-medical oncology ( Site 1304)
Aviano Pordenone, 33081, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)
Orbassano Torino, 10043, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)
Firenze Toscana, 50134, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1305)
Milano , 20132, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)
Milano , 20141, Italy
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)
Roma , 00168, Italy
Chungbuk National University Hospital-Internal medicine ( Site 2004)
Cheongju-si Chungbuk, 28644, Korea, Republic of
Seoul National University Bundang Hospital ( Site 2003)
Seongnam Kyonggi-do, 13620, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)
Suwon-si Kyonggi-do, 16247, Korea, Republic of
Asan Medical Center-Oncology ( Site 2000)
Songpagu Seoul, 05505, Korea, Republic of
Hospital Sultan Ismail ( Site 1503)
Johor Bahru Johor, 81100, Malaysia
University Malaya Medical Centre ( Site 1501)
Lembah Pantai Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan ( Site 1500)
Kuantan Pahang, 25100, Malaysia
Beacon Hospital Sdn Bhd ( Site 1504)
Petaling Jaya Selangor, 46050, Malaysia
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland
Przychodnia Lekarska KOMED ( Site 1704)
Konin Wielkopolskie, 62-50, Poland
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
Saint Petersburg Leningradskaya Oblast, 19002, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)
Saint Petersburg Leningradskaya Oblast, 19825, Russian Federation
Hadassah Medical-Oncology department ( Site 1912)
Moscow Moskovskaya Oblast, 12120, Russian Federation
Moscow Clinical Research Center-Chemotherapy department ( Site 1910)
Moscow Moskva, 11112, Russian Federation
Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)
Moscow Moskva, 12135, Russian Federation
Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)
Nizhniy Novgorod Nizhegorodskaya Oblast, 60308, Russian Federation
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)
Omsk Omskaya Oblast, 64401, Russian Federation
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
GBUZ LOKB-Oncology department #1 ( Site 1905)
Saint-Petersburg Sankt-Peterburg, 19429, Russian Federation
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
Barcelona Cataluna, 08036, Spain
Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)
Barcelona Cataluna, 08041, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)
Madrid , 28009, Spain
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)
Sevilla , 41014, Spain
Ospedale Regionale Bellinzona e Valli ( Site 2203)
Bellinzona Ticino, 6500, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
Taichung Veterans General Hospital-Chest ( Site 2307)
Taichung , 40705, Taiwan
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)
Tainan , 704, Taiwan
National Taiwan University Hospital-Oncology ( Site 2304)
Taipei , 10002, Taiwan
Mackay Memorial Hospital-Chest Medicine ( Site 2305)
Taipei , 10449, Taiwan
Chulalongkorn University ( Site 2403)
Bangkok Krung Thep Maha Nakhon, 10330, Thailand
Faculty of Medicine Siriraj Hospital ( Site 2400)
Bangkok Krung Thep Maha Nakhon, 10700, Thailand

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

240

Study ID:

NCT04725188

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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