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)

NCT04725188 | Completed Phase 2 Results DMC FDA Drug

• 6 other identifiers: 7684A-002MK-7684A-002KEYVIBE-0022022-501252-28-00U1111-1275-86612020-004034-38
• Study Type: interventional
• Target: 255
• Locations: 19 countries
• Sites: 92

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).

Conditions

Metastatic Non Small Cell Lung Cancer

Keywords

Programmed Cell Death Receptor 1 (PD-1); Programmed Cell Death Receptor Ligand 1 (PD-L1); Programmed Cell Death Receptor Ligand 2 (PD-L2); PD-1; PDL1; PD-L1; PD-L2

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment

  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.

  Up to approximately 21 months

Secondary Outcomes (5)

• Objective Response Rate (ORR) Per RECIST 1.1 by BICR Assessment

  Up to approximately 21 months

• Overall Survival (OS)

  Up to approximately 21 months

• Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment

  Up to approximately 21 months

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

  Up to approximately 39 months

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

  Up to approximately 27 months

Study Arms (3)

Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel

EXPERIMENTAL

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.

Biological: Pembrolizumab/Vibostolimab coformulation; Drug: Docetaxel

Arm 2: Pembrolizumab/Vibostolimab coformulation

EXPERIMENTAL

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.

Biological: Pembrolizumab/Vibostolimab coformulation

Arm 3: Placebo + Docetaxel

ACTIVE COMPARATOR

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.

Drug: Docetaxel; Drug: Placebo

Interventions

Pembrolizumab/Vibostolimab coformulation BIOLOGICAL

Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.

Also known as: MK-7684A

Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel; Arm 2: Pembrolizumab/Vibostolimab coformulation

Docetaxel DRUG

Docetaxel 75 mg\^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3.

Also known as: Taxotere

Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel; Arm 3: Placebo + Docetaxel

Placebo DRUG

Normal saline IV infusion Q3W up to approximately 2 years

Arm 3: Placebo + Docetaxel

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (95)

Cedars-Sinai Medical Center ( Site 2522)

Los Angeles, California, 90048, United States

Location

Illinois Cancer Care ( Site 2534)

Peoria, Illinois, 61615, United States

Location

Baptist Health Lexington-Research ( Site 2502)

Lexington, Kentucky, 40503, United States

Location

University of Maryland ( Site 2528)

Baltimore, Maryland, 21201, United States

Location

Hattiesburg Clinic Hematology/Oncology ( Site 2511)

Hattiesburg, Mississippi, 39401, United States

Location

Mercy Research - Cancer and Hematology Center ( Site 2535)

Springfield, Missouri, 65804, United States

Location

Mercy Research - David C. Pratt Cancer Center ( Site 2532)

St Louis, Missouri, 63109, United States

Location

Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)

The Bronx, New York, 10461, United States

Location

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)

Cincinnati, Ohio, 45219, United States

Location

St Francis Cancer Center-Research Office ( Site 2531)

Greenville, South Carolina, 29607, United States

Location

Centro de Oncología e Investigación de Buenos Aires ( Site 0008)

Berazategui, Buenos Aires, B1884BBF, Argentina

Location

Hospital Privado de Comunidad ( Site 0004)

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Instituto de Oncología de Rosario ( Site 0003)

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Hospital Privado Universitario de Córdoba ( Site 0001)

Córdoba, 5016, Argentina

Location

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)

La Rioja, F5300COE, Argentina

Location

Canberra Hospital ( Site 0104)

Canberra, Australian Capital Territory, 2605, Australia

Location

Gold Coast University Hospital-Clinical Trials Service ( Site 0106)

Southport, Queensland, 4215, Australia

Location

Fiona Stanley Hospital-Medical Oncology ( Site 0102)

Murdoch, Western Australia, 6150, Australia

Location

Medizinische Universität Graz ( Site 0201)

Graz, Styria, 8036, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)

Linz, Upper Austria, 4020, Austria

Location

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)

Vienna, 1210, Austria

Location

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)

Mechelen, Antwerpen, 2800, Belgium

Location

UZ Brussel ( Site 0336)

Brussels, Bruxelles-Capitale, Region de, 1090, Belgium

Location

Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)

Charleroi, Hainaut, 6000, Belgium

Location

Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)

Hasselt, Limburg, 3500, Belgium

Location

AZ Nikolaas ( Site 0334)

Sint-Niklaas, Oost-Vlaanderen, 1932, Belgium

Location

Hospital Nossa Senhora da Conceição ( Site 0403)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)

São Paulo, São Paulo, 01246-000, Brazil

Location

Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)

Rio de Janeiro, 22250-905, Brazil

Location

Hospital Paulistano ( Site 0406)

São Paulo, 01321-000, Brazil

Location

Rigshospitalet ( Site 0702)

Copenhagen, Capital Region, 2100, Denmark

Location

Odense Universitetshospital ( Site 0700)

Odense, Region Syddanmark, 5000, Denmark

Location

Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)

Sønderborg, Region Syddanmark, 6400, Denmark

Location

Oulun yliopistollinen sairaala ( Site 0902)

Oulu, North Ostrobothnia, 90220, Finland

Location

Tampereen yliopistollinen sairaala-Oncology ( Site 0906)

Tampere, Pirkanmaa, 33520, Finland

Location

Vaasan Keskussairaala ( Site 0903)

Vaasa, Pohjanmaa, 65130, Finland

Location

Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)

Turku, Southwest Finland, 20520, Finland

Location

Nouvel Hôpital Civil (NHC) ( Site 1000)

Strasbourg, Alsace, 67000, France

Location

Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)

Bordeaux, Aquitaine, 33000, France

Location

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)

Caen, Calvados, 14033, France

Location

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)

Toulouse, Haute-Garonne, 31059, France

Location

Clinique Ambroise Paré ( Site 1007)

Beuvry, Pas-de-Calais, 62660, France

Location

Centre Hospitalier du Mans ( Site 1002)

Le Mans, Sarthe, 72037, France

Location

Gustave Roussy ( Site 1005)

Villejuif, Val-de-Marne, 94800, France

Location

HIA Sainte Anne ( Site 1003)

Toulon, Var, 83800 Cedex 9, France

Location

Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)

Avignon, Vaucluse, 84000, France

Location

Onkologie Ravensburg ( Site 1104)

Ravensburg, Baden-Wurttemberg, 88212, Germany

Location

Klinikverbund Allgaeu gGmbH ( Site 1109)

Immenstadt im Allgäu, Bavaria, 87509, Germany

Location

Helios Dr. Horst Schmidt Kliniken ( Site 1108)

Wiesbaden, Hesse, 65199, Germany

Location

Universitätsklinikum Bonn ( Site 1111)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)

Berlin, 14165, Germany

Location

Soroka Medical Center ( Site 1202)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus-Oncology ( Site 1203)

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center-Oncology ( Site 1206)

Jerusalem, 9103102, Israel

Location

Sourasky Medical Center ( Site 1205)

Tel Aviv, 6423906, Israel

Location

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)

Rome, Lazio, 00184, Italy

Location

Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)

Naples, Napoli, 80131, Italy

Location

CRO-IRCCS-medical oncology ( Site 1304)

Aviano, Pordenone, 33081, Italy

Location

Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)

Orbassano, Torino, 10043, Italy

Location

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)

Florence, Tuscany, 50134, Italy

Location

Ospedale San Raffaele-Oncologia Medica ( Site 1305)

Milan, 20132, Italy

Location

Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)

Milan, 20141, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)

Roma, 00168, Italy

Location

Hospital Sultan Ismail ( Site 1503)

Johor Bahru, Johor, 81100, Malaysia

Location

University Malaya Medical Centre ( Site 1501)

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan ( Site 1500)

Kuantan, Pahang, 25100, Malaysia

Location

Beacon Hospital Sdn Bhd ( Site 1504)

Petaling Jaya, Selangor, 46050, Malaysia

Location

Przychodnia Lekarska KOMED ( Site 1704)

Konin, Greater Poland Voivodeship, 62-500, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

Saint Petersburg, Leningradskaya Oblast', 190020, Russia

Location

Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)

Saint Petersburg, Leningradskaya Oblast', 198255, Russia

Location

Moscow Clinical Research Center-Chemotherapy department ( Site 1910)

Moscow, Moscow, 111123, Russia

Location

Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)

Moscow, Moscow, 121359, Russia

Location

Hadassah Medical-Oncology department ( Site 1912)

Moscow, Moscow Oblast, 121205, Russia

Location

Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia

Location

Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)

Omsk, Omsk Oblast, 644013, Russia

Location

GBUZ LOKB-Oncology department #1 ( Site 1905)

Saint Petersburg, Sankt-Peterburg, 194291, Russia

Location

N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Seoul National University Bundang Hospital ( Site 2003)

Seongnam, Kyonggi-do, 13620, South Korea

Location

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)

Suwon, Kyonggi-do, 16247, South Korea

Location

Chungbuk National University Hospital-Internal medicine ( Site 2004)

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Asan Medical Center-Oncology ( Site 2000)

Songpagu, Seoul, 05505, South Korea

Location

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)

Barcelona, Catalonia, 08041, Spain

Location

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)

Madrid, 28009, Spain

Location

Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)

Seville, 41014, Spain

Location

Ospedale Regionale Bellinzona e Valli ( Site 2203)

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Taichung Veterans General Hospital-Chest ( Site 2307)

Taichung, 40705, Taiwan

Location

NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital-Oncology ( Site 2304)

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital-Chest Medicine ( Site 2305)

Taipei, 10449, Taiwan

Location

Chulalongkorn University ( Site 2403)

Bangkok, Bangkok, 10330, Thailand

Location

Faculty of Medicine Siriraj Hospital ( Site 2400)

Bangkok, Bangkok, 10700, Thailand

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Docetaxel

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Arm 1 and Arm 3: Double-blind with in-house blinding Arm 2: Unblinded Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 26, 2021
• Study Start: April 20, 2021
• Primary Completion: January 26, 2023
• Study Completion: October 17, 2024
• Last Updated: August 15, 2025
• Results First Posted: April 2, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

TH (2); BR (4); FR (9); BE (5); IL (4); AR (6); AU (3); DK (3); PL (2); FI (4); ES (4); CH (1); MY (4); KR (4); TW (5); IT (8); US (10); RU (9); DE (5)