A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants w

Trial Details

NCT ID
NCT06385080
Phase
PHASE1 / PHASE2
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Amivantamab
  • Pembrolizumab
  • Paclitaxel
  • Carboplatin
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742
  • Aurora, Colorado, United States|39.72943,-104.83192
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is consi…
  • Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must…
  • Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less pr…
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

For full eligibility, visit ClinicalTrials.gov.

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