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)

Completed · Phase 4

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

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.

Key facts

Study ID

NCT04489888

Run by

Merck Sharp & Dohme LLC

People needed

101

Starts

2020-10-27

Expected to finish

2024-06-28

Last updated by the study team

2025-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale-New Haven Hospital-Yale Cancer Center ( Site 0265) — New Haven, Connecticut, United States
• Helen F. Graham Cancer Center & Research Institute ( Site 0214) — Newark, Delaware, United States
• Baptist MD Anderson Cancer Center ( Site 0215) — Jacksonville, Florida, United States
• Orlando Health, Inc. ( Site 0216) — Orlando, Florida, United States
• Regions Hospital ( Site 0227) — Saint Paul, Minnesota, United States
• Washington University School of Medicine ( Site 0240) — St Louis, Missouri, United States
• Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268) — Buffalo, New York, United States
• Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262) — Mineola, New York, United States
• Novant Health Presbyterian ( Site 0261) — Charlotte, North Carolina, United States
• Novant Health Forsyth Medical Center ( Site 0266) — Winston-Salem, North Carolina, United States
• UPMC Hillman Cancer Center ( Site 0253) — Pittsburgh, Pennsylvania, United States
• Abington Hospital - Asplundh Cancer Center ( Site 0229) — Willow Grove, Pennsylvania, United States
• Charleston Oncology ( Site 0231) — Charleston, South Carolina, United States
• Virginia Commonwealth University ( Site 0233) — Richmond, Virginia, United States
• Hospital Provincial del Centenario ( Site 0304) — Rosario, Santa Fe Province, Argentina
• Centro Medico San Roque ( Site 0302) — San Miguel de Tucumán, Tucumán Province, Argentina
• IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303) — Buenos Aires, Argentina
• Fundación Respirar ( Site 0306) — Buenos Aires, Argentina
• Instituto Medico Especializado Alexander Fleming ( Site 0301) — Buenos Aires, Argentina
• Orange Health Services ( Site 0106) — Orange, New South Wales, Australia
• The Townsville Hospital ( Site 0105) — Douglas, Queensland, Australia
• Gold Coast University Hospital ( Site 0103) — Southport, Queensland, Australia
• St Vincents Hospital Melbourne ( Site 0101) — Fitzroy, Victoria, Australia
• Centro Regional Integrado de Oncologia ( Site 0403) — Fortaleza, Ceará, Brazil
• CETUS Hospital Dia Oncologia ( Site 0400) — Belo Horizonte, Minas Gerais, Brazil

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.