MK-3475 Taxane Combo Single-Arm Phase 4

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 firstline treatment of recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTEB10).

  • Clinical Trial Information

    Trial Contact: Deronvil, France; Thomas, Andrea L

    Trial Phone: 321.841.3498 ; 321.841.8284

  • IRB No: WIRB 20201664

    Protocol Abbrev: MK3475-B10

    Principal Investigator: Jennifer E. Tseng, MD

    Phase: Drug: Phase IV

    Age Group: Adult

    Secondary Protocol No: KEYNOTEB10

    Treatment: All participants will receive: Pembrolizumab 200 mg IV Q3W. Pembrolizumab dose reductions are not permitted. Carboplatin AUC 5 mg/mL/min IV Q3W. Paclitaxel 100 mg/m2 IV Q1W or paclitaxel 175 mg/m2 Q3W per investigator’s choice.

    Therapies Involved: Medication ID: NCT04489888

  • Objective

    To evaluate the efficacy of pembrolizumab + carboplatin + paclitaxel with respect to objective response rate (ORR) per RECIST 1.1 as assessed by blinded independent central review (BICR).

  • Key Eligibility

    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 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 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