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Active, not recruiting Phase 3

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)

NCT05224141 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2022-03-24
Last updated
2025-07-08

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

Pembrolizumab/Vibostolimab Co-Formulation →Saline placeboEtoposide →Cisplatin →Atezolizumab →Carboplatin →

Pembrolizumab/Vibostolimab Co-Formulation: 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.

Saline placebo: Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)

Etoposide: Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles

Cisplatin: Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Atezolizumab: Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.

Carboplatin: Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (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: The main exclusion criteria include but are not limited to the following: * 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

Primary outcome measure(s)

  • Overall Survival (OS) — Up to approximately 25 months
    Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.

Trial sites (140)

FacilityCityRegionStatus
Infirmary Cancer Care ( Site 0022) Mobile Alabama
Los Angeles Hematology Oncology Medical Group ( Site 0006) Los Angeles California
VA West Los Angeles Medical Center ( Site 0004) Los Angeles California
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) Boca Raton Florida
Fort Wayne Medical Oncology and Hematology ( Site 0013) Fort Wayne Indiana
Dana-Farber Cancer Institute ( Site 0018) Boston Massachusetts
Cancer and Hematology Centers of Western Michigan ( Site 0001) Grand Rapids Michigan
Hattiesburg Clinic Hematology/Oncology ( Site 0003) Hattiesburg Mississippi
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) Lancaster Pennsylvania
Blue Ridge Cancer Care ( Site 0015) Blacksburg Virginia
University of Virginia Cancer Center ( Site 0019) Charlottesville Virginia
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) Ciudad Autonoma de Buenos Aires Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata Buenos Aires
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) Buenos Aires Buenos Aires F.D.
Hospital Provincial del Centenario ( Site 0205) Rosario Santa Fe Province
Sanatorio Parque ( Site 0202) Rosario Santa Fe Province
Nepean Hospital ( Site 2700) Kingswood New South Wales
Calvary Mater Newcastle ( Site 2703) Waratah New South Wales
Frankston Hospital-Oncology and Haematology ( Site 2702) Frankston Victoria
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) Melbourne Victoria
Medizinische Universität Graz ( Site 0504) Graz Styria
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) Linz Upper Austria
Kepler Universitätsklinikum ( Site 0507) Linz Upper Austria
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0502) Vienna Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0501) Vienna Austria
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0106) Kingston Ontario
Lakeridge Health ( Site 0102) Oshawa Ontario
Anhui Cancer Hospital ( Site 2915) Hefei Anhui
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901) Beijing Beijing Municipality
Beijing Peking Union Medical College Hospital ( Site 2921) Beijing Beijing Municipality
Fujian Provincial Cancer Hospital-oncology department ( Site 2904) Fuzhou Fujian
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920) Harbin Heilongjiang
Henan Cancer Hospital ( Site 2916) Zhengzhou Henan
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2912) Wuhan Hubei
Hubei Cancer Hospital ( Site 2922) Wuhan Hubei
Hunan Cancer Hospital ( Site 2907) Changsha Hunan
The First Affiliated Hospital of Soochow University ( Site 2913) Suzhou Jiangsu
Jilin Cancer Hospital-GCP office ( Site 2909) Changchun Jilin
The First Hospital of Jilin University ( Site 2914) Changchun Jilin
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910) Xi'an Shaanxi

+ 100 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05224141 on ClinicalTrials.gov ↗ ← All trials in Italy