Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
Detailed Description
With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2027
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT05224141
Start Date
March 24 2022
End Date
June 7 2027
Last Update
July 8 2025
Active Locations (140)
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1
Infirmary Cancer Care ( Site 0022)
Mobile, Alabama, United States, 36607
2
Los Angeles Hematology Oncology Medical Group ( Site 0006)
Los Angeles, California, United States, 90017
3
VA West Los Angeles Medical Center ( Site 0004)
Los Angeles, California, United States, 90073
4
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
Boca Raton, Florida, United States, 33486