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Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Primary Purpose

Metastatic Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab/Vibostolimab
Carboplatin
Cisplatin
Paclitaxel
Nab-paclitaxel
Pemetrexed
Pembrolizumab
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

Eligibility Criteria

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

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC.
  • Has not received prior systemic treatment for metastatic NSCLC.
  • Has measurable disease based on RECIST 1.1, as determined by the local site assessment.
  • Has a life expectancy of at least 3 months.
  • Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method.

Exclusion Criteria:

  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
  • Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus.
  • Received prior systemic anticancer therapy for metastatic disease.
  • Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • History of allogenic tissue/solid organ transplant.
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation.
  • 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.

Sites / Locations

  • UCHealth Memorial Hospital-Heme Onc ( Site 0003)
  • University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
  • Mayo Clinic in Florida ( Site 0022)
  • Mount Sinai Hospital ( Site 0011)
  • University of Chicago Medical Center ( Site 0015)
  • New England Cancer Specialists ( Site 0008)
  • Cancer and Hematology Centers of Western Michigan ( Site 0002)
  • Mayo Clinic in Rochester, Minnesota ( Site 0030)
  • Stony Brook University-Cancer Center ( Site 0013)
  • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
  • Charleston Oncology ( Site 0019)
  • University of Virginia Cancer Center ( Site 0018)
  • Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
  • Sanatorio Parque ( Site 0205)
  • Hospital Provincial del Centenario ( Site 0212)
  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
  • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
  • Kepler Universitätsklinikum ( Site 0707)
  • Medizinische Universität Graz ( Site 0704)
  • Medizinische Universitaet Innsbruck ( Site 0703)
  • Klinik Penzing-2. Lungenabteilung ( Site 0702)
  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
  • Clínica de Oncologia Reichow ( Site 0407)
  • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
  • Hospital Paulistano ( Site 0401)
  • James Lind Centro de Investigación del Cáncer ( Site 0502)
  • CIDO SpA-Oncology ( Site 0508)
  • Biocenter ( Site 0514)
  • FALP-UIDO ( Site 0505)
  • Centro de Oncología de Precisión ( Site 0515)
  • Bradfordhill ( Site 0510)
  • ONCOCENTRO APYS-ACEREY ( Site 0503)
  • Centro de Investigación Oncológica del Norte ( Site 0504)
  • Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
  • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
  • Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
  • The First Affiliated hospital of Xiamen University ( Site 2626)
  • Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
  • Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
  • Henan Cancer Hospital ( Site 2608)
  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
  • Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
  • Xiangya Hospital Central South University-Oncology department ( Site 2627)
  • The Second Xiangya Hospital of Central South University ( Site 2623)
  • Hunan Cancer Hospital ( Site 2622)
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
  • The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
  • The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
  • Jilin Cancer Hospital-oncology department ( Site 2603)
  • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
  • Shandong Cancer Hospital-Oncology Department ( Site 2630)
  • Fudan University Shanghai Cancer Center ( Site 2616)
  • Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
  • West China Hospital of Sichuan University ( Site 2610)
  • Sichuan Cancer hospital ( Site 2628)
  • The Second People's Hospital of Yibin ( Site 2629)
  • Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
  • The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
  • Zhejiang Cancer Hospital-Oncology ( Site 2612)
  • The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
  • Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
  • Oncomedica S.A.-Oncomedica S.A ( Site 0609)
  • Administradora Country S.A. - Clinica del Country ( Site 0601)
  • Oncologos del Occidente ( Site 0608)
  • CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
  • Centre Hospitalier d'Annecy ( Site 0807)
  • Institut de Cancérologie de l'Ouest ( Site 0802)
  • Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
  • CENTRE LEON BERARD ( Site 0803)
  • HIA Sainte Anne ( Site 0804)
  • Centre Hospitalier d'Avignon ( Site 0810)
  • UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
  • GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
  • Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
  • SRH Wald-Klinikum Gera ( Site 0911)
  • Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
  • Rambam Health Care Campus-Oncology ( Site 1303)
  • Shaare Zedek Medical Center-Oncology ( Site 1306)
  • Meir Medical Center-oncology ( Site 1301)
  • Sheba Medical Center-ONCOLOGY ( Site 1302)
  • Sourasky Medical Center-Oncology ( Site 1305)
  • National Hospital Organization Shikoku Cancer Center ( Site 2414)
  • Ehime University Hospital ( Site 2411)
  • Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
  • Kanazawa University Hospital ( Site 2407)
  • Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
  • Miyagi Cancer Center ( Site 2401)
  • Kansai Medical University Hospital ( Site 2415)
  • Saitama Prefectural Cancer Center ( Site 2406)
  • Shizuoka Cancer Center ( Site 2408)
  • Japanese Foundation for Cancer Research ( Site 2402)
  • Showa University Hospital ( Site 2403)
  • National Hospital Organization Kyushu Medical Center ( Site 2413)
  • National Hospital Organization Kyushu Cancer Center ( Site 2412)
  • Okayama University Hospital ( Site 2410)
  • Nippon Medical School Hospital ( Site 2404)
  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
  • Pusan National University Hospital ( Site 2205)
  • Asan Medical Center ( Site 2206)
  • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
  • Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
  • Korea University Guro Hospital-Internal Medicine ( Site 2204)
  • CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
  • Alivia Clínica de Alta Especialidad ( Site 0310)
  • Arké SMO S.A. de C.V. ( Site 0301)
  • Hospital Civil Fray Antonio Alcalde ( Site 0307)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
  • Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
  • Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
  • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
  • Przychodnia Lekarska KOMED ( Site 1902)
  • Med-Polonia Sp. z o. o. ( Site 1909)
  • CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
  • Hospital Insular de Gran Canaria-Oncology ( Site 1102)
  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
  • Hospital Clinico San Carlos-Oncology Department ( Site 1107)
  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
  • Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
  • China Medical University Hospital ( Site 2253)
  • NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
  • National Taiwan University Hospital-Oncology ( Site 2255)
  • Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
  • Faculty of Medicine - Khon Kaen University ( Site 2303)
  • Faculty of Medicine Siriraj Hospital ( Site 2304)
  • Chulabhorn Hospital ( Site 2305)
  • Songklanagarind hospital ( Site 2302)
  • Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
  • Acibadem Altunizade Hospital-Oncology ( Site 1207)
  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
  • Hacettepe Universitesi-oncology hospital ( Site 1202)
  • Liv Hospital Ankara-Oncology ( Site 1205)
  • Ankara City Hospital ( Site 1204)
  • Trakya University-Medical Oncology ( Site 1203)
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
  • Umraniye Training and Research Hospital-medical oncology ( Site 1206)
  • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
  • Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
  • University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed

Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed

Arm Description

Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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 blinded independent central review (BICR) will be presented.
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause.

Secondary Outcome Measures

Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or 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 CR or PR as assessed by BICR will be presented.
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline for Role Functioning Combined (Items 6 and 7) Score on the EORTC QLQ-C30
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Change from Baseline in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
TTD in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
TTD in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
TTD in the score of EORTC QLQ-C13 Item 40 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Number of Participants Who Experienced One or More Adverse Events (AEs)
The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinued Study Intervention Due to an AE
The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Duration of Response (DOR)
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.

Full Information

First Posted
January 26, 2022
Last Updated
May 15, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05226598
Brief Title
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Official Title
A Randomized, Double-Blind, Phase 3 Study of MK-7684A Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
November 10, 2025 (Anticipated)
Study Completion Date
September 27, 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 primary hypotheses are that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Arm Title
Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed
Arm Type
Active Comparator
Arm Description
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Vibostolimab
Other Intervention Name(s)
MK-7684A
Intervention Description
Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®, Paraplatin NovaPlus ®
Intervention Description
Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol-AQ®
Intervention Description
Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®, ONXOL®
Intervention Description
Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
ABRAXANE®
Intervention Description
Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta®
Intervention Description
Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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 blinded independent central review (BICR) will be presented.
Time Frame
Up to approximately 33 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 42 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or 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 CR or PR as assessed by BICR will be presented.
Time Frame
Up to approximately 42 months
Title
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Time Frame
Baseline and Up to approximately 42 months
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and Up to approximately 42 months
Title
Change from Baseline for Role Functioning Combined (Items 6 and 7) Score on the EORTC QLQ-C30
Description
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Baseline and up to approximately 42 months
Title
Change from Baseline in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Time Frame
Baseline and Up to approximately 42 months
Title
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)
Description
Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Time Frame
Baseline and Up to approximately 42 months
Title
Change from Baseline in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
Change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time Frame
Baseline and Up to approximately 42 months
Title
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Up to approximately 42 months
Title
TTD in Physical Functioning (Items 1-5) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Up to approximately 42 months
Title
TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Description
TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time Frame
Up to approximately 42 months
Title
TTD in Dyspnea Score (Item 8) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Up to approximately 42 months
Title
TTD in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
TTD in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Up to approximately 42 months
Title
TTD in Chest Pain Score (Item 40) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
TTD in the score of EORTC QLQ-C13 Item 40 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time Frame
Up to approximately 42 months
Title
Number of Participants Who Experienced One or More Adverse Events (AEs)
Description
The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Time Frame
Up to approximately 42 months
Title
Number of Participants Who Discontinued Study Intervention Due to an AE
Description
The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Time Frame
Up to approximately 42 months
Title
Duration of Response (DOR)
Description
For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
Time Frame
Up to approximately 42 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC. Has not received prior systemic treatment for metastatic NSCLC. Has measurable disease based on RECIST 1.1, as determined by the local site assessment. Has a life expectancy of at least 3 months. Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method. Exclusion Criteria: Known additional malignancy that is progressing or has required active treatment within the past 3 years. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Severe hypersensitivity to vibostolimab, pembrolizumab, chemotherapy components, and/or any of its excipients. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus. Received prior systemic anticancer therapy for metastatic disease. Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. History of allogenic tissue/solid organ transplant. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). Is unable or unwilling to take folic acid or vitamin B12 supplementation. 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.
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
UCHealth Memorial Hospital-Heme Onc ( Site 0003)
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Mayo Clinic in Florida ( Site 0022)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mount Sinai Hospital ( Site 0011)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
University of Chicago Medical Center ( Site 0015)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
New England Cancer Specialists ( Site 0008)
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan ( Site 0002)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic in Rochester, Minnesota ( Site 0030)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Stony Brook University-Cancer Center ( Site 0013)
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Charleston Oncology ( Site 0019)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
University of Virginia Cancer Center ( Site 0018)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Centro de Oncología e Investigación de Buenos Aires ( Site 0203)
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)
City
ABB
State/Province
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Sanatorio Parque ( Site 0205)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Provincial del Centenario ( Site 0212)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2002
Country
Argentina
Facility Name
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Kepler Universitätsklinikum ( Site 0707)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Medizinische Universität Graz ( Site 0704)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitaet Innsbruck ( Site 0703)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinik Penzing-2. Lungenabteilung ( Site 0702)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701)
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Clínica de Oncologia Reichow ( Site 0407)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Hospital Paulistano ( Site 0401)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 0502)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Facility Name
CIDO SpA-Oncology ( Site 0508)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810148
Country
Chile
Facility Name
Biocenter ( Site 0514)
City
Concepción
State/Province
Biobio
ZIP/Postal Code
4070196
Country
Chile
Facility Name
FALP-UIDO ( Site 0505)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
6900941
Country
Chile
Facility Name
Centro de Oncología de Precisión ( Site 0515)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7560908
Country
Chile
Facility Name
Bradfordhill ( Site 0510)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
ONCOCENTRO APYS-ACEREY ( Site 0503)
City
Viña del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Centro de Investigación Oncológica del Norte ( Site 0504)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Facility Name
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2619)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230036
Country
China
Facility Name
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2602)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Provincial Cancer Hospital-oncology department ( Site 2621)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated hospital of Xiamen University ( Site 2626)
City
Xiamen City
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Harbin Medical University Cancer Hospital-oncology of department ( Site 2604)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Henan Cancer Hospital ( Site 2608)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Tongji Medical,Science & Technology ( Site 2617)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Xiangya Hospital Central South University-Oncology department ( Site 2627)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University ( Site 2623)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Hunan Cancer Hospital ( Site 2622)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital-oncology department ( Site 2603)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Shandong Cancer Hospital-Oncology Department ( Site 2630)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 2616)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
West China Hospital of Sichuan University ( Site 2610)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Cancer hospital ( Site 2628)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The Second People's Hospital of Yibin ( Site 2629)
City
Yibin
State/Province
Sichuan
ZIP/Postal Code
644000
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital-lung cancer ( Site 2606)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 2613)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2615)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital-Oncology ( Site 2612)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 0603)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A.-Oncomedica S.A ( Site 0609)
City
Montería
State/Province
Cordoba
ZIP/Postal Code
230001
Country
Colombia
Facility Name
Administradora Country S.A. - Clinica del Country ( Site 0601)
City
Bogotá
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Oncologos del Occidente ( Site 0608)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Facility Name
CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)
City
Orléans
State/Province
Centre
ZIP/Postal Code
45067
Country
France
Facility Name
Centre Hospitalier d'Annecy ( Site 0807)
City
Epagny Metz-Tessy
State/Province
Haute-Savoie
ZIP/Postal Code
74370
Country
France
Facility Name
Institut de Cancérologie de l'Ouest ( Site 0802)
City
ANGERS cedex 02
State/Province
Maine-et-Loire
ZIP/Postal Code
49055
Country
France
Facility Name
Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59037
Country
France
Facility Name
CENTRE LEON BERARD ( Site 0803)
City
Lyon CEDEX 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
HIA Sainte Anne ( Site 0804)
City
Toulon
State/Province
Var
ZIP/Postal Code
83800 Cedex 9
Country
France
Facility Name
Centre Hospitalier d'Avignon ( Site 0810)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84000
Country
France
Facility Name
UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
GEFOS Gesellschaft f. onkologische Studien ( Site 0909)
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44263
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
SRH Wald-Klinikum Gera ( Site 0911)
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07548
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Rambam Health Care Campus-Oncology ( Site 1303)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center-Oncology ( Site 1306)
City
Jerusalem
ZIP/Postal Code
9013102
Country
Israel
Facility Name
Meir Medical Center-oncology ( Site 1301)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center-ONCOLOGY ( Site 1302)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center-Oncology ( Site 1305)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 2414)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Ehime University Hospital ( Site 2411)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Hyogo Cancer Center-Thoracic Oncology ( Site 2409)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 2407)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Miyagi Cancer Center ( Site 2401)
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 2415)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Saitama Prefectural Cancer Center ( Site 2406)
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center ( Site 2408)
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Japanese Foundation for Cancer Research ( Site 2402)
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Showa University Hospital ( Site 2403)
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
1428666
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 2413)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 2412)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Okayama University Hospital ( Site 2410)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 2404)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)
City
Hwasun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Pusan National University Hospital ( Site 2205)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2206)
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)
City
Deagu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chungnam national university hospital-Department of Internal Medicine ( Site 2203)
City
Daejeon
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital-Internal Medicine ( Site 2204)
City
Seoul
Country
Korea, Republic of
Facility Name
CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25279
Country
Mexico
Facility Name
Alivia Clínica de Alta Especialidad ( Site 0310)
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Arké SMO S.A. de C.V. ( Site 0301)
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital Civil Fray Antonio Alcalde ( Site 0307)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-125
Country
Poland
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
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)
City
Prabuty
State/Province
Pomorskie
ZIP/Postal Code
82-550
Country
Poland
Facility Name
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)
City
Bystra
State/Province
Slaskie
ZIP/Postal Code
43-360
Country
Poland
Facility Name
Przychodnia Lekarska KOMED ( Site 1902)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Med-Polonia Sp. z o. o. ( Site 1909)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Facility Name
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)
City
A Coruña
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Insular de Gran Canaria-Oncology ( Site 1102)
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35001
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinico San Carlos-Oncology Department ( Site 1107)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 2253)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital-Oncology ( Site 2255)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 2251)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Faculty of Medicine - Khon Kaen University ( Site 2303)
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 2304)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chulabhorn Hospital ( Site 2305)
City
Lak Si
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10210
Country
Thailand
Facility Name
Songklanagarind hospital ( Site 2302)
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 2301)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Acibadem Altunizade Hospital-Oncology ( Site 1207)
City
Üsküdar / Stanbul
State/Province
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 1202)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Liv Hospital Ankara-Oncology ( Site 1205)
City
Ankara
ZIP/Postal Code
06680
Country
Turkey
Facility Name
Ankara City Hospital ( Site 1204)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Trakya University-Medical Oncology ( Site 1203)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Umraniye Training and Research Hospital-medical oncology ( Site 1206)
City
Istanbul
ZIP/Postal Code
34766
Country
Turkey
Facility Name
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
City
Leicester
State/Province
England
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)
City
London
State/Province
England
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)
City
London-Camden
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

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
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information

Learn more about this trial

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

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