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Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

Primary Purpose

Small Cell Lung Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab/Vibostolimab Co-Formulation
Saline placebo
Etoposide
Cisplatin
Atezolizumab
Carboplatin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
  • Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
  • Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
  • Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
  • Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  • Has a predicted life expectancy of >3 months

Exclusion Criteria:

  • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
  • Has received prior treatment for Small Cell Lung Cancer (SCLC)
  • Is expected to require any other form of antineoplastic therapy for SCLC while on study
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has had an allogenic tissue/solid organ transplant
  • Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
  • Has symptomatic ascites or pleural effusion

Sites / Locations

  • Infirmary Cancer Care ( Site 0022)
  • Los Angeles Hematology Oncology Medical Group ( Site 0006)
  • VA West Los Angeles Medical Center ( Site 0004)
  • Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
  • Fort Wayne Medical Oncology and Hematology ( Site 0013)
  • Dana-Farber Cancer Institute ( Site 0018)
  • Cancer and Hematology Centers of Western Michigan ( Site 0001)
  • Hattiesburg Clinic Hematology/Oncology ( Site 0003)
  • Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
  • Blue Ridge Cancer Care ( Site 0015)
  • University of Virginia Cancer Center ( Site 0019)
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
  • Sanatorio Parque ( Site 0202)
  • Hospital Provincial del Centenario ( Site 0205)
  • Nepean Hospital ( Site 2700)
  • Calvary Mater Newcastle ( Site 2703)
  • Frankston Hospital-Oncology and Haematology ( Site 2702)
  • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
  • Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
  • Kepler Universitätsklinikum ( Site 0507)
  • Medizinische Universität Graz ( Site 0504)
  • Klinik Penzing-2. Lungenabteilung ( Site 0502)
  • Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)
  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)
  • Lakeridge Health ( Site 0102)
  • Anhui Cancer Hospital ( Site 2915)
  • Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
  • Beijing Peking Union Medical College Hospital ( Site 2921)
  • Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
  • Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
  • Henan Cancer Hospital ( Site 2916)
  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)
  • Hubei Cancer Hospital ( Site 2922)
  • Hunan Cancer Hospital ( Site 2907)
  • The First Affiliated Hospital of Soochow University ( Site 2913)
  • Jilin Cancer Hospital-GCP office ( Site 2909)
  • The First Hospital of Jilin University ( Site 2914)
  • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
  • Shanghai Chest Hospital-Oncology department ( Site 2900)
  • Fudan University Shanghai Cancer Center ( Site 2908)
  • Sichuan Cancer hospital ( Site 2923)
  • West China Hospital Sichuan University ( Site 2903)
  • Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
  • Zhejiang Cancer Hospital-Oncology ( Site 2919)
  • Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
  • Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
  • Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
  • CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané
  • Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
  • Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
  • Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)
  • LungenClinic Grosshansdorf-Onkologie ( Site 0903)
  • SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
  • Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
  • Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
  • Metropolitan Hospital ( Site 1001)
  • University General Hospital of Heraklion ( Site 1004)
  • European Interbalkan Medical Center ( Site 1000)
  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
  • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
  • Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
  • Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
  • St. James's Hospital ( Site 1200)
  • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
  • Rambam Health Care Campus-Oncology ( Site 1301)
  • Shaare Zedek Medical Center-Oncology ( Site 1300)
  • Sheba Medical Center-ONCOLOGY ( Site 1302)
  • Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)
  • Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)
  • Aichi Cancer Center Hospital ( Site 3016)
  • National Cancer Center Hospital East ( Site 3002)
  • National Hospital Organization Shikoku Cancer Center ( Site 3012)
  • Kurume University Hospital ( Site 3014)
  • National Hospital Organization Hokkaido Cancer Center ( Site 3015)
  • Kanazawa University Hospital ( Site 3006)
  • Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)
  • Sendai Kousei Hospital ( Site 3001)
  • Niigata Cancer Center Hospital ( Site 3005)
  • Kansai Medical University Hospital ( Site 3009)
  • Shizuoka Cancer Center ( Site 3007)
  • Japanese Foundation for Cancer Research ( Site 3003)
  • National Hospital Organization Kyushu Medical Center ( Site 3013)
  • Okayama University Hospital ( Site 3011)
  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
  • Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
  • Chungnam national university hospital-Department of Internal Medicine ( Site 2802)
  • Korea University Guro Hospital-Internal Medicine ( Site 2803)
  • Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
  • National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
  • Arké SMO S.A. de C.V. ( Site 0401)
  • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
  • Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
  • iCan Oncology Center Centro Medico AVE ( Site 0406)
  • Centro de Investigacion Clinica de Oaxaca ( Site 0410)
  • Medische Centrum Leeuwarden ( Site 1619)
  • Ziekenhuis Rijnstate ( Site 1606)
  • Maastricht UMC+-Pulmonary disease ( Site 1602)
  • Jeroen Bosch Hospital-Pulmonology ( Site 1605)
  • Isala, locatie Zwolle-Poli Longziekten ( Site 1612)
  • Erasmus Medisch Centrum ( Site 1621)
  • Martini Ziekenhuis ( Site 1618)
  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)
  • Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)
  • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)
  • Przychodnia Lekarska KOMED ( Site 1701)
  • Med-Polonia Sp. z o. o. ( Site 1710)
  • Champalimaud Foundation ( Site 1812)
  • Hospital CUF Descobertas ( Site 1815)
  • Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)
  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)
  • MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)
  • Centrul medical Focus ( Site 1903)
  • Cardiomed SRL Cluj-Napoca ( Site 1900)
  • Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)
  • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901)
  • Cabinet Medical Oncomed ( Site 1902)
  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)
  • H.R.U Málaga - Hospital General-Oncology ( Site 2104)
  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)
  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)
  • Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)
  • I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)
  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)
  • Hacettepe Universitesi-oncology hospital ( Site 2409)
  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)
  • Ankara Bilkent City Hospital ( Site 2403)
  • Medipol University Medical Faculty-oncology ( Site 2400)
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)
  • The Christie-Clinical Research Facility ( Site 2607)
  • Mount Vernon Hospital ( Site 2602)
  • Heartlands Hospital-Oncology Research ( Site 2604)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab/Vibostolimab

Atezolizumab

Arm Description

Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall Survival (OS) is the time from randomization to the date of death due to any cause.

Secondary Outcome Measures

Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who have a 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).
Duration of Response (DOR)
Duration of Response (DOR) is the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), until progressive disease (PD) or death.
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
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)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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 EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related 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 in Dyspnea Score (Item 8) on the EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related 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 Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
The EORTC QLQ-LC13 is a lung cancer specific health-related 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 EORTC QLQ-LC13
EORTC QLQ-LC13 is a lung cancer specific health-related 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 True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. 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 QoL 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 EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related 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 Dyspnea Score (Item 8) on the EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related 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 EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung cancer specific health-related 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 EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung cancer specific health-related 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.

Full Information

First Posted
January 25, 2022
Last Updated
October 5, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05224141
Brief Title
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)
Official Title
A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination With Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination With Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
May 8, 2025 (Anticipated)
Study Completion Date
June 7, 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
This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab/Vibostolimab
Arm Type
Experimental
Arm Description
Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Arm Title
Atezolizumab
Arm Type
Active Comparator
Arm Description
Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab/Vibostolimab Co-Formulation
Other Intervention Name(s)
MK-7684A
Intervention Description
Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Intervention Description
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide 100 mg/m^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
PLATINOL-AQ®
Intervention Description
Cisplatin 75 mg/m^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Intervention Type
Biological
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
TECENTRIQ®
Intervention Description
Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS) is the time from randomization to the date of death due to any cause.
Time Frame
Up to approximately 37 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Progression-Free Survival (PFS) is the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 26 months
Title
Objective Response Rate (ORR)
Description
Objective Response Rate (ORR) is the percentage of participants who have a 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).
Time Frame
Up to approximately 37 months
Title
Duration of Response (DOR)
Description
Duration of Response (DOR) is the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), until progressive disease (PD) or death.
Time Frame
Up to approximately 37 months
Title
Percentage of Participants Who Experienced an Adverse Event (AE)
Description
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 60 months
Title
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Description
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 60 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
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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 37 months
Title
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Description
The EORTC QLQ-C30 is a cancer specific health-related 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 37 months
Title
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Description
The EORTC QLQ-C30 is a cancer specific health-related 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 37 months
Title
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related 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 37 months
Title
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Description
EORTC QLQ-LC13 is a lung cancer specific health-related 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 37 months
Title
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. 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 QoL 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
Baseline and up to approximately 37 months
Title
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Description
The EORTC QLQ-C30 is a cancer specific health-related 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
Baseline and up to approximately 37 months
Title
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
Description
The EORTC QLQ-C30 is a cancer specific health-related 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
Baseline and up to approximately 37 months
Title
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related 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
Baseline and up to approximately 37 months
Title
TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Description
The EORTC QLQ-LC13 is a lung cancer specific health-related 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
Baseline and 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 histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Has a predicted life expectancy of >3 months Exclusion Criteria: Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease Has received prior treatment for Small Cell Lung Cancer (SCLC) Is expected to require any other form of antineoplastic therapy for SCLC while on study Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication Has a known additional malignancy that is progressing or has required active treatment within the past 3 years Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease Has a known history of, or active, neurologic paraneoplastic syndrome Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of Hepatitis B or known active Hepatitis C virus infection Has had an allogenic tissue/solid organ transplant Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention Has symptomatic ascites or pleural effusion
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
Infirmary Cancer Care ( Site 0022)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652
Country
United States
Facility Name
Los Angeles Hematology Oncology Medical Group ( Site 0006)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
VA West Los Angeles Medical Center ( Site 0004)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology ( Site 0013)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Dana-Farber Cancer Institute ( Site 0018)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan ( Site 0001)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hattiesburg Clinic Hematology/Oncology ( Site 0003)
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Blue Ridge Cancer Care ( Site 0015)
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
University of Virginia Cancer Center ( Site 0019)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
City
ABB
State/Province
Caba
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Sanatorio Parque ( Site 0202)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Provincial del Centenario ( Site 0205)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2002
Country
Argentina
Facility Name
Nepean Hospital ( Site 2700)
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Calvary Mater Newcastle ( Site 2703)
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Frankston Hospital-Oncology and Haematology ( Site 2702)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Kepler Universitätsklinikum ( Site 0507)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Medizinische Universität Graz ( Site 0504)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinik Penzing-2. Lungenabteilung ( Site 0502)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501)
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Lakeridge Health ( Site 0102)
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Anhui Cancer Hospital ( Site 2915)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Peking Union Medical College Hospital ( Site 2921)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 2916)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hubei Cancer Hospital ( Site 2922)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital ( Site 2907)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First Affiliated Hospital of Soochow University ( Site 2913)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Jilin Cancer Hospital-GCP office ( Site 2909)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The First Hospital of Jilin University ( Site 2914)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Shanghai Chest Hospital-Oncology department ( Site 2900)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 2908)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Sichuan Cancer hospital ( Site 2923)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
West China Hospital Sichuan University ( Site 2903)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611135
Country
China
Facility Name
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital-Oncology ( Site 2919)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
City
Vaasa
State/Province
Pohjanmaa
ZIP/Postal Code
65130
Country
Finland
Facility Name
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20521
Country
Finland
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13915
Country
France
Facility Name
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
City
Immenhausen
State/Province
Hessen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Medizinische Hochschule Hannover-Department of Pneumology ( Site 0901)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
LungenClinic Grosshansdorf-Onkologie ( Site 0903)
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07548
Country
Germany
Facility Name
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 26
Country
Greece
Facility Name
Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan Hospital ( Site 1001)
City
Athens
State/Province
Attiki
ZIP/Postal Code
185 47
Country
Greece
Facility Name
University General Hospital of Heraklion ( Site 1004)
City
Heraklion
State/Province
Irakleio
ZIP/Postal Code
711 10
Country
Greece
Facility Name
European Interbalkan Medical Center ( Site 1000)
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
City
Törökbálint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
St. James's Hospital ( Site 1200)
City
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Facility Name
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
City
Dublin
ZIP/Postal Code
Dublin 9
Country
Ireland
Facility Name
Rambam Health Care Campus-Oncology ( Site 1301)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center-Oncology ( Site 1300)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Sheba Medical Center-ONCOLOGY ( Site 1302)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
City
Naples
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1403)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1400)
City
Rome
State/Province
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 3016)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 3002)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 3012)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Kurume University Hospital ( Site 3014)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center ( Site 3015)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 3006)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Sendai Kousei Hospital ( Site 3001)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9800873
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 3005)
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 3009)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Shizuoka Cancer Center ( Site 3007)
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Japanese Foundation for Cancer Research ( Site 3003)
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 3013)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Okayama University Hospital ( Site 3011)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
City
Hwasun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
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 2802)
City
Daejeon
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital-Internal Medicine ( Site 2803)
City
Seoul
Country
Korea, Republic of
Facility Name
Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
City
Klaipeda
State/Province
Klaipedos Miestas
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
City
Vilnius
State/Province
Vilniaus Miestas
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
Arké SMO S.A. de C.V. ( Site 0401)
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Facility Name
iCan Oncology Center Centro Medico AVE ( Site 0406)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Centro de Investigacion Clinica de Oaxaca ( Site 0410)
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Medische Centrum Leeuwarden ( Site 1619)
City
Leeuwarden
State/Province
Fryslan
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate ( Site 1606)
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Maastricht UMC+-Pulmonary disease ( Site 1602)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Jeroen Bosch Hospital-Pulmonology ( Site 1605)
City
Den Bosch
State/Province
Noord-Brabant
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Isala, locatie Zwolle-Poli Longziekten ( Site 1612)
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Erasmus Medisch Centrum ( Site 1621)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Martini Ziekenhuis ( Site 1618)
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
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 1703)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)
City
Prabuty
State/Province
Pomorskie
ZIP/Postal Code
82-550
Country
Poland
Facility Name
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)
City
Bystra
State/Province
Slaskie
ZIP/Postal Code
43-360
Country
Poland
Facility Name
Przychodnia Lekarska KOMED ( Site 1701)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Med-Polonia Sp. z o. o. ( Site 1710)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Champalimaud Foundation ( Site 1812)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Hospital CUF Descobertas ( Site 1815)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António ( Site 1813)
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1810)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 1905)
City
București
State/Province
Bucuresti
ZIP/Postal Code
022343
Country
Romania
Facility Name
Centrul medical Focus ( Site 1903)
City
București
State/Province
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 1900)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1904)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200385
Country
Romania
Facility Name
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 1901)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200746
Country
Romania
Facility Name
Cabinet Medical Oncomed ( Site 1902)
City
Timișoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Facility Name
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Facility Name
H.R.U Málaga - Hospital General-Oncology ( Site 2104)
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2402)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
I.E.U. Medical Point Hastanesi-Oncology ( Site 2408)
City
Izmir, Karsiyaka
State/Province
Izmir
ZIP/Postal Code
009035575
Country
Turkey
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2407)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe Universitesi-oncology hospital ( Site 2409)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Memorial Ankara Hastanesi-Medical Oncology ( Site 2406)
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Ankara Bilkent City Hospital ( Site 2403)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Medipol University Medical Faculty-oncology ( Site 2400)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2401)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
The Christie-Clinical Research Facility ( Site 2607)
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4bx
Country
United Kingdom
Facility Name
Mount Vernon Hospital ( Site 2602)
City
Northwood
State/Province
Hillingdon
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Heartlands Hospital-Oncology Research ( Site 2604)
City
Birmingham
ZIP/Postal Code
B9 5SS
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
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7684A-008&&kw=7684A-008
Description
Plain Language Summary

Learn more about this trial

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

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