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)
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04725188
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel Pembrolizumab/Vibostolimab coformuation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle will be 21 days. Arm 2: Pembrolizumab/Vibostolimab coformulation Pembrolizumab/Vibostolimab coformuation Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle will be 21 days. Arm 3: Placebo + Docetaxel Docetaxel Participants receive normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 IV infusion Q3W. Each cycle will be 21 days. Arm 3: Placebo + Docetaxel Placebo Participants receive normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 IV infusion Q3W. Each cycle will be 21 days. Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel Docetaxel Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle will be 21 days.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment Up to approximately 21 months PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Per RECIST 1.1 by BICR Assessment Up to approximately 21 months ORR is defined as the percentage of participants who have a confirmed complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Overall Survival (OS) Up to approximately 21 months OS is defined as the time from randomization to the date of death due to any cause.
Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment Up to approximately 21 months For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed by BICR is presented.
Number of Participants Who Experienced an Adverse Event (AE) Up to approximately 21 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Number of participants who experienced an AE is reported.
Number of Participants Who Discontinued Study Treatment Due to an AE Up to approximately 18 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Number of participants who discontinued study treatment due to an AE is reported.
Trial Locations
- Locations (95)
Cedars-Sinai Medical Center ( Site 2522)
🇺🇸Los Angeles, California, United States
University of Maryland ( Site 2528)
🇺🇸Baltimore, Maryland, United States
UZ Brussel ( Site 0336)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
Hospital Nossa Senhora da Conceição ( Site 0403)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sultan Ismail ( Site 1503)
🇲🇾Johor Bahru, Johor, Malaysia
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)
🇫🇷Caen, Calvados, France
Faculty of Medicine Siriraj Hospital ( Site 2400)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)
🇧🇪Charleroi, Hainaut, Belgium
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)
🇫🇷Toulouse, Haute-Garonne, France
Mackay Memorial Hospital-Chest Medicine ( Site 2305)
🇨🇳Taipei, Taiwan
University Malaya Medical Centre ( Site 1501)
🇲🇾Lembah Pantai, Kuala Lumpur, Malaysia
Ospedale Regionale Bellinzona e Valli ( Site 2203)
🇨🇭Bellinzona, Ticino, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Taichung Veterans General Hospital-Chest ( Site 2307)
🇨🇳Taichung, Taiwan
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)
🇦🇹Linz, Oberosterreich, Austria
Hattiesburg Clinic Hematology/Oncology ( Site 2511)
🇺🇸Hattiesburg, Mississippi, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0008)
🇦🇷Berazategui, Buenos Aires, Argentina
Baptist Health Lexington-Research ( Site 2502)
🇺🇸Lexington, Kentucky, United States
Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)
🇺🇸Bronx, New York, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)
🇺🇸Cincinnati, Ohio, United States
Canberra Hospital ( Site 0104)
🇦🇺Canberra, Australian Capital Territory, Australia
Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)
🇧🇪Hasselt, Limburg, Belgium
Fiona Stanley Hospital-Medical Oncology ( Site 0102)
🇦🇺Murdoch, Western Australia, Australia
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)
🇧🇷São Paulo, Sao Paulo, Brazil
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)
🇧🇪Mechelen, Antwerpen, Belgium
Vaasan Keskussairaala ( Site 0903)
🇫🇮Vaasa, Pohjanmaa, Finland
Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)
🇩🇰Soenderborg, Syddanmark, Denmark
Hospital Paulistano ( Site 0406)
🇧🇷Sao Paulo, Brazil
Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)
🇧🇷Rio de Janeiro, Brazil
Tampereen yliopistollinen sairaala-Oncology ( Site 0906)
🇫🇮Tampere, Pirkanmaa, Finland
Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 2003)
🇰🇷Seongnam, Kyonggi-do, Korea, Republic of
Hadassah Medical-Oncology department ( Site 1912)
🇷🇺Moscow, Moskovskaya Oblast, Russian Federation
Sourasky Medical Center ( Site 1205)
🇮🇱Tel Aviv, Israel
Centre Hospitalier du Mans ( Site 1002)
🇫🇷Le Mans, Sarthe, France
Gustave Roussy ( Site 1005)
🇫🇷Villejuif, Val-de-Marne, France
HIA Sainte Anne ( Site 1003)
🇫🇷Toulon, Var, France
Onkologie Ravensburg ( Site 1104)
🇩🇪Ravensburg, Baden-Wurttemberg, Germany
Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)
🇫🇷Avignon, Vaucluse, France
Asan Medical Center-Oncology ( Site 2000)
🇰🇷Songpagu, Seoul, Korea, Republic of
Hospital Tengku Ampuan Afzan ( Site 1500)
🇲🇾Kuantan, Pahang, Malaysia
Rambam Health Care Campus-Oncology ( Site 1203)
🇮🇱Haifa, Israel
National Taiwan University Hospital-Oncology ( Site 2304)
🇨🇳Taipei, Taiwan
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)
🇮🇹Roma, Lazio, Italy
Beacon Hospital Sdn Bhd ( Site 1504)
🇲🇾Petaling Jaya, Selangor, Malaysia
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)
🇮🇹Roma, Italy
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)
🇪🇸Madrid, Spain
Moscow Clinical Research Center-Chemotherapy department ( Site 1910)
🇷🇺Moscow, Moskva, Russian Federation
Chulalongkorn University ( Site 2403)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Rigshospitalet ( Site 0702)
🇩🇰Copenhagen, Hovedstaden, Denmark
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)
🇮🇹Naples, Napoli, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1305)
🇮🇹Milano, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)
🇮🇹Milano, Italy
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)
🇪🇸Sevilla, Spain
Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)
🇪🇸Barcelona, Cataluna, Spain
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
Hospital Privado de Comunidad ( Site 0004)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Hospital Privado Universitario de Córdoba ( Site 0001)
🇦🇷Cordoba, Argentina
Illinois Cancer Care ( Site 2534)
🇺🇸Peoria, Illinois, United States
Mercy Research - Cancer and Hematology Center ( Site 2535)
🇺🇸Springfield, Missouri, United States
Mercy Research - David C. Pratt Cancer Center ( Site 2532)
🇺🇸Saint Louis, Missouri, United States
St Francis Cancer Center-Research Office ( Site 2531)
🇺🇸Greenville, South Carolina, United States
Instituto de Oncología de Rosario ( Site 0003)
🇦🇷Rosario, Santa Fe, Argentina
Gold Coast University Hospital-Clinical Trials Service ( Site 0106)
🇦🇺Southport, Queensland, Australia
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)
🇦🇷La Rioja, Argentina
Medizinische Universität Graz ( Site 0201)
🇦🇹Graz, Steiermark, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)
🇦🇹Wien, Austria
AZ Nikolaas ( Site 0334)
🇧🇪Sint-Niklaas, Oost-Vlaanderen, Belgium
Odense Universitetshospital ( Site 0700)
🇩🇰Odense, Syddanmark, Denmark
Oulun yliopistollinen sairaala ( Site 0902)
🇫🇮Oulu, Pohjois-Pohjanmaa, Finland
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)
🇫🇮Turku, Varsinais-Suomi, Finland
Nouvel Hôpital Civil (NHC) ( Site 1000)
🇫🇷Strasbourg, Alsace, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)
🇫🇷Bordeaux, Aquitaine, France
Klinikverbund Allgaeu gGmbH ( Site 1109)
🇩🇪Immenstadt im Allgäu, Bayern, Germany
Helios Dr. Horst Schmidt Kliniken ( Site 1108)
🇩🇪Wiesbaden, Hessen, Germany
Clinique Ambroise Paré ( Site 1007)
🇫🇷Beuvry, Pas-de-Calais, France
Universitätsklinikum Bonn ( Site 1111)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)
🇮🇹Orbassano, Torino, Italy
Soroka Medical Center ( Site 1202)
🇮🇱Be'er Sheva, Israel
Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)
🇩🇪Berlin, Germany
CRO-IRCCS-medical oncology ( Site 1304)
🇮🇹Aviano, Pordenone, Italy
Shaare Zedek Medical Center-Oncology ( Site 1206)
🇮🇱Jerusalem, Israel
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)
🇮🇹Firenze, Toscana, Italy
Chungbuk National University Hospital-Internal medicine ( Site 2004)
🇰🇷Cheongju-si, Chungbuk, Korea, Republic of
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
🇷🇺Saint Petersburg, Leningradskaya Oblast, Russian Federation
GBUZ LOKB-Oncology department #1 ( Site 1905)
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)
🇷🇺Omsk, Omskaya Oblast, Russian Federation
Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)
🇷🇺Moscow, Moskva, Russian Federation
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
🇪🇸Barcelona, Cataluna, Spain
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)
🇨🇳Tainan, Taiwan
Przychodnia Lekarska KOMED ( Site 1704)
🇵🇱Konin, Wielkopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
🇵🇱Warszawa, Mazowieckie, Poland