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)

  • STATUS
    Recruiting
  • End date
    Jul 25, 2024
  • participants needed
    100
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 20 September 2021
paclitaxel
carcinoma
squamous cell carcinoma
carboplatin
pembrolizumab
mk-3475
metastatic head and neck squamous cell carcinoma

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 squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.

Details
Condition Squamous cell carcinoma, head and neck cancer, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of Head and Neck
Treatment carboplatin, Paclitaxel, Pembrolizumab
Clinical Study IdentifierNCT04489888
SponsorMerck Sharp & Dohme Corp.
Last Modified on20 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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