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)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Small Cell Lung Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05224141
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 460
- Starts
- 2022-03-24
- Expected to finish
- 2027-06-07
- Last updated by the study team
- 2025-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Los Angeles Hematology Oncology Medical Group ( Site 0006) — Los Angeles, California, United States
- VA West Los Angeles Medical Center ( Site 0004) — Los Angeles, California, United States
- Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) — Boca Raton, Florida, United States
- Fort Wayne Medical Oncology and Hematology ( Site 0013) — Fort Wayne, Indiana, United States
- Dana-Farber Cancer Institute ( Site 0018) — Boston, Massachusetts, United States
- Cancer and Hematology Centers of Western Michigan ( Site 0001) — Grand Rapids, Michigan, United States
- Hattiesburg Clinic Hematology/Oncology ( Site 0003) — Hattiesburg, Mississippi, United States
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005) — Lancaster, Pennsylvania, United States
- Blue Ridge Cancer Care ( Site 0015) — Blacksburg, Virginia, United States
- University of Virginia Cancer Center ( Site 0019) — Charlottesville, Virginia, United States
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) — Mar del Plata, Buenos Aires, Argentina
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200) — Buenos Aires, Buenos Aires F.D., Argentina
- Hospital Provincial del Centenario ( Site 0205) — Rosario, Santa Fe Province, Argentina
- Sanatorio Parque ( Site 0202) — Rosario, Santa Fe Province, Argentina
- Nepean Hospital ( Site 2700) — Kingswood, New South Wales, Australia
- Calvary Mater Newcastle ( Site 2703) — Waratah, New South Wales, Australia
- Frankston Hospital-Oncology and Haematology ( Site 2702) — Frankston, Victoria, Australia
- Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701) — Melbourne, Victoria, Australia
- Medizinische Universität Graz ( Site 0504) — Graz, Styria, Austria
- Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505) — Linz, Upper Austria, Austria
- Kepler Universitätsklinikum ( Site 0507) — Linz, Upper Austria, 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
- Infirmary Cancer Care ( Site 0022) — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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