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)
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.
Checked against the public recordLast updated Jul 8, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Biological: Pembrolizumab/Vibostolimab Co-Formulation; Drug: Saline placebo; Drug: Etoposide; Drug: Cisplatin; Biological: Atezolizumab; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- 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
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 8, 2025. Always confirm current availability with the study team.