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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)

Primary Purpose

Metastatic Non Small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab/Vibostolimab coformuation
Docetaxel
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non Small Cell Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center ( Site 2522)
  • Illinois Cancer Care ( Site 2534)
  • Baptist Health Lexington-Research ( Site 2502)
  • University of Maryland ( Site 2528)
  • Hattiesburg Clinic Hematology/Oncology ( Site 2511)
  • Mercy Research - David C. Pratt Cancer Center ( Site 2532)
  • Mercy Research - Cancer and Hematology Center ( Site 2535)
  • Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)
  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)
  • St Francis Cancer Center-Research Office ( Site 2531)
  • Centro de Oncología e Investigación de Buenos Aires ( Site 0008)
  • Hospital Privado de Comunidad ( Site 0004)
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)
  • Instituto de Oncología de Rosario ( Site 0003)
  • Hospital Privado Universitario de Córdoba ( Site 0001)
  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)
  • Canberra Hospital ( Site 0104)
  • Gold Coast University Hospital-Clinical Trials Service ( Site 0106)
  • Fiona Stanley Hospital-Medical Oncology ( Site 0102)
  • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)
  • Medizinische Universität Graz ( Site 0201)
  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)
  • AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)
  • UZ Brussel ( Site 0336)
  • Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)
  • Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)
  • AZ Nikolaas ( Site 0334)
  • Hospital Nossa Senhora da Conceição ( Site 0403)
  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)
  • Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)
  • Hospital Paulistano ( Site 0406)
  • Rigshospitalet ( Site 0702)
  • Odense Universitetshospital ( Site 0700)
  • Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)
  • Tampereen yliopistollinen sairaala-Oncology ( Site 0906)
  • Vaasan Keskussairaala ( Site 0903)
  • Oulun yliopistollinen sairaala ( Site 0902)
  • Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)
  • Nouvel Hôpital Civil (NHC) ( Site 1000)
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)
  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)
  • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)
  • Clinique Ambroise Paré ( Site 1007)
  • Centre Hospitalier du Mans ( Site 1002)
  • Gustave Roussy ( Site 1005)
  • HIA Sainte Anne ( Site 1003)
  • Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)
  • Onkologie Ravensburg ( Site 1104)
  • Klinikverbund Allgaeu gGmbH ( Site 1109)
  • Helios Dr. Horst Schmidt Kliniken ( Site 1108)
  • Universitätsklinikum Bonn ( Site 1111)
  • Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)
  • Soroka Medical Center ( Site 1202)
  • Rambam Health Care Campus-Oncology ( Site 1203)
  • Shaare Zedek Medical Center-Oncology ( Site 1206)
  • Sourasky Medical Center ( Site 1205)
  • Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)
  • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)
  • CRO-IRCCS-medical oncology ( Site 1304)
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)
  • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)
  • Ospedale San Raffaele-Oncologia Medica ( Site 1305)
  • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)
  • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)
  • Chungbuk National University Hospital-Internal medicine ( Site 2004)
  • Seoul National University Bundang Hospital ( Site 2003)
  • The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)
  • Asan Medical Center-Oncology ( Site 2000)
  • Hospital Sultan Ismail ( Site 1503)
  • University Malaya Medical Centre ( Site 1501)
  • Hospital Tengku Ampuan Afzan ( Site 1500)
  • Beacon Hospital Sdn Bhd ( Site 1504)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
  • Przychodnia Lekarska KOMED ( Site 1704)
  • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
  • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)
  • Hadassah Medical-Oncology department ( Site 1912)
  • Moscow Clinical Research Center-Chemotherapy department ( Site 1910)
  • Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)
  • Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)
  • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)
  • N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
  • GBUZ LOKB-Oncology department #1 ( Site 1905)
  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
  • Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)
  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)
  • Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)
  • Ospedale Regionale Bellinzona e Valli ( Site 2203)
  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)
  • Taichung Veterans General Hospital-Chest ( Site 2307)
  • NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)
  • National Taiwan University Hospital-Oncology ( Site 2304)
  • Mackay Memorial Hospital-Chest Medicine ( Site 2305)
  • Chulalongkorn University ( Site 2403)
  • Faculty of Medicine Siriraj Hospital ( Site 2400)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel

Arm 2: Pembrolizumab/Vibostolimab coformulation

Arm 3: Placebo + Docetaxel

Arm Description

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 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity.

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.

Participants receive normal saline IV infusion, Q3W for up to 35 cycles up to approximately 2 years plus Docetaxel 75 mg/m^2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity.

Outcomes

Primary Outcome Measures

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 will be presented

Secondary Outcome Measures

Objective Response (OR) per RECIST 1.1 by BICR Assessment
OR is defined as 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 will be presented.
Overall Survival (OS)
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
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 will be presented.
Number of Participants Who Experienced an Adverse Event (AE)
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 experience an AE will be reported.
Number of Participants Who Discontinued Study Treatment Due to an AE
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 discontinue study treatment due to an AE will be reported.

Full Information

First Posted
January 25, 2021
Last Updated
July 4, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04725188
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
August 13, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Arm 1 and Arm 3: Double-blind with in-house blinding Arm 2: Unblinded Open-label
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel
Arm Type
Experimental
Arm Description
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 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity.
Arm Title
Arm 2: Pembrolizumab/Vibostolimab coformulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3: Placebo + Docetaxel
Arm Type
Active Comparator
Arm Description
Participants receive normal saline IV infusion, Q3W for up to 35 cycles up to approximately 2 years plus Docetaxel 75 mg/m^2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Vibostolimab coformuation
Other Intervention Name(s)
MK-7684A
Intervention Description
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline IV infusion Q3W up to approximately 2 years
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment
Description
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 will be presented
Time Frame
Up to approximately 27 months
Secondary Outcome Measure Information:
Title
Objective Response (OR) per RECIST 1.1 by BICR Assessment
Description
OR is defined as 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 will be presented.
Time Frame
Up to approximately 27 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to the date of death due to any cause.
Time Frame
Up to approximately 77 months
Title
Duration of Response (DOR) per RECIST 1.1 by BICR Assessment
Description
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 will be presented.
Time Frame
Up to approximately 77 months
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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 experience an AE will be reported.
Time Frame
Up to approximately 77 months
Title
Number of Participants Who Discontinued Study Treatment Due to an AE
Description
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 discontinue study treatment due to an AE will be reported.
Time Frame
Up to approximately 37 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7684A-002&&kw=7684A-002
Description
Plain Language Summary

Learn more about this 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)

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