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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Pembrolizumab

Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle

drug

Carboplatin

Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle

drug

Paclitaxel

At investigator's choice, paclitaxel 100 mg/m\^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each 21-day cycle

Ubicaciones

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

A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Efficacy and Safety of MK-3475 Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE B10).

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pembrolizumab

Carboplatin

Paclitaxel

Ubicaciones

Hospital Provincial del Centenario ( Site 0304)

Centro Medico San Roque ( Site 0302)

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)

Fundación Respirar ( Site 0306)

Instituto Medico Especializado Alexander Fleming ( Site 0301)

Patrocinadores