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)

A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

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).

Study Overview

• Status: Completed
• Conditions: Metastatic Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Placebo; Biological: Pembrolizumab/Vibostolimab coformulation

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.

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, 5016
    • Hospital Privado Universitario de Córdoba ( Site 0001)
  • La Rioja, Argentina, F5300COE
    • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, B1884BBF
      • Centro de Oncología e Investigación de Buenos Aires ( Site 0008)
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Hospital Privado de Comunidad ( Site 0004)
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KZE
      • Instituto de Oncología de Rosario ( Site 0003)
• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2605
      • Canberra Hospital ( Site 0104)
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital-Clinical Trials Service ( Site 0106)
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital-Medical Oncology ( Site 0102)
• Austria
  • Wien, Austria, 1210
    • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)
  • Oberosterreich
    • Linz, Oberosterreich, Austria, 4020
      • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz ( Site 0201)
• Belgium
  • Antwerpen
    • Mechelen, Antwerpen, Belgium, 2800
      • AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)
  • Bruxelles-Capitale, Region De
    • Brussels, Bruxelles-Capitale, Region De, Belgium, 1090
      • UZ Brussel ( Site 0336)
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)
  • Oost-Vlaanderen
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 1932
      • AZ Nikolaas ( Site 0334)
• Brazil
  • Rio de Janeiro, Brazil, 22250-905
    • Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)
  • Sao Paulo, Brazil, 01321-000
    • Hospital Paulistano ( Site 0406)
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao ( Site 0403)
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01246-000
      • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)
• Denmark
  • Hovedstaden
    • Copenhagen, Hovedstaden, Denmark, 2100
      • Rigshospitalet ( Site 0702)
  • Syddanmark
    • Odense, Syddanmark, Denmark, 5000
      • Odense Universitetshospital ( Site 0700)
    • Soenderborg, Syddanmark, Denmark, 6400
      • Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)
• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampereen yliopistollinen sairaala-Oncology ( Site 0906)
  • Pohjanmaa
    • Vaasa, Pohjanmaa, Finland, 65130
      • Vaasan Keskussairaala ( Site 0903)
  • Pohjois-Pohjanmaa
    • Oulu, Pohjois-Pohjanmaa, Finland, 90220
      • Oulun yliopistollinen sairaala ( Site 0902)
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20520
      • Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)
• France
  • Alsace
    • Strasbourg, Alsace, France, 67000
      • Nouvel Hôpital Civil (NHC) ( Site 1000)
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)
  • Calvados
    • Caen, Calvados, France, 14033
      • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)
  • Pas-de-Calais
    • Beuvry, Pas-de-Calais, France, 62660
      • Clinique Ambroise Paré ( Site 1007)
  • Sarthe
    • Le Mans, Sarthe, France, 72037
      • Centre Hospitalier du Mans ( Site 1002)
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94800
      • Gustave Roussy ( Site 1005)
  • Var
    • Toulon, Var, France, 83800 Cedex 9
      • HIA Sainte Anne ( Site 1003)
  • Vaucluse
    • Avignon, Vaucluse, France, 84000
      • Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)
• Germany
  • Berlin, Germany, 14165
    • Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)
  • Baden-Wurttemberg
    • Ravensburg, Baden-Wurttemberg, Germany, 88212
      • Onkologie Ravensburg ( Site 1104)
  • Bayern
    • Immenstadt im Allgäu, Bayern, Germany, 87509
      • Klinikverbund Allgaeu gGmbH ( Site 1109)
  • Hessen
    • Wiesbaden, Hessen, Germany, 65199
      • Helios Dr. Horst Schmidt Kliniken ( Site 1108)
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Universitätsklinikum Bonn ( Site 1111)
• Israel
  • Be'er Sheva, Israel, 8410101
    • Soroka Medical Center ( Site 1202)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Oncology ( Site 1203)
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center-Oncology ( Site 1206)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 1205)
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele-Oncologia Medica ( Site 1305)
  • Milano, Italy, 20141
    • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)
  • Lazio
    • Roma, Lazio, Italy, 00184
      • Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • CRO-IRCCS-medical oncology ( Site 1304)
  • Torino
    • Orbassano, Torino, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)
• Korea, Republic of
  • Chungbuk
    • Cheongju-si, Chungbuk, Korea, Republic of, 28644
      • Chungbuk National University Hospital-Internal medicine ( Site 2004)
  • Kyonggi-do
    • Seongnam, Kyonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital ( Site 2003)
    • Suwon-si, Kyonggi-do, Korea, Republic of, 16247
      • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)
  • Seoul
    • Songpagu, Seoul, Korea, Republic of, 05505
      • Asan Medical Center-Oncology ( Site 2000)
• Malaysia
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail ( Site 1503)
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre ( Site 1501)
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Hospital Tengku Ampuan Afzan ( Site 1500)
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 46050
      • Beacon Hospital Sdn Bhd ( Site 1504)
• Poland
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
  • Wielkopolskie
    • Konin, Wielkopolskie, Poland, 62-500
      • Przychodnia Lekarska KOMED ( Site 1704)
• Russian Federation
  • Leningradskaya Oblast
    • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 190020
      • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
    • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 198255
      • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)
  • Moskovskaya Oblast
    • Moscow, Moskovskaya Oblast, Russian Federation, 121205
      • Hadassah Medical-Oncology department ( Site 1912)
  • Moskva
    • Moscow, Moskva, Russian Federation, 111123
      • Moscow Clinical Research Center-Chemotherapy department ( Site 1910)
    • Moscow, Moskva, Russian Federation, 121359
      • Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)
  • Nizhegorodskaya Oblast
    • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603081
      • Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)
  • Omskaya Oblast
    • Omsk, Omskaya Oblast, Russian Federation, 644013
      • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
      • N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194291
      • GBUZ LOKB-Oncology department #1 ( Site 1905)
• Spain
  • Madrid, Spain, 28009
    • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)
  • Cataluna
    • Barcelona, Cataluna, Spain, 08036
      • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
    • Barcelona, Cataluna, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)
• Switzerland
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • Ospedale Regionale Bellinzona e Valli ( Site 2203)
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital-Chest ( Site 2307)
  • Tainan, Taiwan, 704
    • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital-Oncology ( Site 2304)
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital-Chest Medicine ( Site 2305)
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)
• Thailand
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
      • Chulalongkorn University ( Site 2403)
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital ( Site 2400)
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center ( Site 2522)
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care ( Site 2534)
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington-Research ( Site 2502)
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland ( Site 2528)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic Hematology/Oncology ( Site 2511)
  • Missouri
    • Saint Louis, Missouri, United States, 63109
      • Mercy Research - David C. Pratt Cancer Center ( Site 2532)
    • Springfield, Missouri, United States, 65804
      • Mercy Research - Cancer and Hematology Center ( Site 2535)
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • St Francis Cancer Center-Research Office ( Site 2531)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Pembrolizumab/Vibostolimab coformulation + 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.	Drug: Docetaxel; 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.; Other Names: Taxotere; Biological: Pembrolizumab/Vibostolimab coformulation; Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.; Other Names: MK-7684A
Experimental: Arm 2: Pembrolizumab/Vibostolimab coformulation; 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; Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.; Other Names: MK-7684A
Active Comparator: Arm 3: Placebo + 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.	Drug: Docetaxel; 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.; Other Names: Taxotere; Drug: Placebo; Normal saline IV infusion Q3W up to approximately 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Per RECIST 1.1 by BICR Assessment	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.	Up to approximately 21 months
Overall Survival (OS)	OS is defined as the time from randomization to the date of death due to any cause.	Up to approximately 21 months
Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment	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.	Up to approximately 21 months
Number of Participants Who Experienced an Adverse Event (AE)	An AE was 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. The number of participants who experienced an AE is reported here.	Up to approximately 39 months
Number of Participants Who Discontinued Study Treatment Due to an AE	An AE was 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. The number of participants who discontinued study treatment due to an AE is reported here.	Up to approximately 27 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: PD-1; PD-L1; PDL1; Programmed Cell Death Receptor 1 (PD-1); Programmed Cell Death Receptor Ligand 1 (PD-L1); Programmed Cell Death Receptor Ligand 2 (PD-L2); PD-L2
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Disease Progression; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Pembrolizumab
• Other Study ID Numbers: 7684A-002; MK-7684A-002 (Other Identifier: MSD); KEYVIBE-002 (Other Identifier: MSD); 2020-004034-38 (EudraCT Number); 2022-501252-28-00 (Registry Identifier: EU CT); U1111-1275-8661 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No