Phase 4
N=101
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)
Squamous Cell Carcinoma of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT04489888 ↗Enrolled (actual)
101
Serious AEs
51.5%
Results posted
May 2024
Primary outcome: Primary: Objective Response Rate (ORR) — 48.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pembrolizumab (Drug); Carboplatin (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
48.5 | — |
| SECONDARY Duration of Response (DOR) |
5.5 | — |
| SECONDARY Progression-free Survival (PFS) |
5.6 | — |
| SECONDARY Overall Survival (OS) |
13.1 | — |
| SECONDARY Percentage of Participants Who Experienced an Adverse Event (AE) |
100.0 | — |
| SECONDARY Percentage of Participants Who Discontinued Study Treatment Due to an AE |
36.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04489888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.