Status:
COMPLETED
A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck ...
Eligibility Criteria
Inclusion
- Has histologically or cytologically-confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies
- Male participants refrain from donating sperm plus are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 95 days after carboplatin/paclitaxel
- Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or 30 days after paclitaxel or 6 months after carboplatin whichever occurs last, and agree not to donate or freeze eggs during this period
- Has adequate organ function
Exclusion
- Has disease that is suitable for local therapy administered with curative intent
- Has a life expectancy of less than 3 months and/or has rapidly progressive disease
- Has a diagnosed and/or treated additional malignancy within 5 years prior to allocation with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has a history of or current non-infectious pneumonitis/interstitial lung disease that requires steroids
- 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 Hepatitis C virus infection
- Has had an allogenic tissue/solid organ transplant
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04489888
Start Date
October 27 2020
End Date
June 28 2024
Last Update
June 19 2025
Active Locations (35)
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1
Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)
New Haven, Connecticut, United States, 06510
2
Helen F. Graham Cancer Center & Research Institute ( Site 0214)
Newark, Delaware, United States, 19718
3
Baptist MD Anderson Cancer Center ( Site 0215)
Jacksonville, Florida, United States, 32207
4
Orlando Health, Inc. ( Site 0216)
Orlando, Florida, United States, 32806