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Closed (no longer recruiting)Last updated: 19 September 2024

KEYNOTEB10: This phase IV trial will evaluate the safety and effectiveness of an immunotherapy, combined with chemotherapy, as first line treatment for patients with recurrent or metastatic head and neck squamous cell carcinomaA 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).

Clinical summary

Summary

Eligible patients will receive intravenous pembrolizumab (immunotherapy), carboplatin and paclitaxel (chemotherapy).

Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle, for up to 35 cycles (~2 years).

Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle, for up to 6 cycles (~4 months).

Paclitaxel will be administered, at the investigator's choice, either via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (~4 months).

Conditions

This trial is treating patients with head and neck squamous cell carcinoma

Cancer

Head and Neck Cancers Head and Neck

Age

People18 - 120

Phase

IV

Trial Acronym

KEYNOTEB10

More information

Trial Identifiers

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Trial sponsor

Merck

Scientific Title

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).

Eligibility

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

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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