OncoMatch/Clinical Trials/NCT06385080
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Is NCT06385080 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Amivantamab and Pembrolizumab for squamous cell carcinoma of head and neck.
Treatment: Amivantamab · Pembrolizumab · Paclitaxel · Carboplatin — 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 with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 negative (negative)
Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing)
Required: CDKN2A p16 positive (positive)
Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue
Required: HPV high-risk HPV positive by ISH (positive)
Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue
Required: PD-L1 (CD274) testing required
Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Cannot have received: targeted cancer therapy
Exception: within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Cannot have received: immunotherapy
Exception: within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Cannot have received: investigational anticancer agent
Exception: within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
Cannot have received: radiotherapy for palliative purposes
Exception: within 7 days of the first administration of study treatment
Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment
Lab requirements
Blood counts
hemoglobin >=9 g/dl; neutrophils >=1.5 x 10^3/mcg; platelets >=100 x 10^3/mcg
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California at San Diego Moores Cancer Center · La Jolla, California
- University of Colorado Denver Anschultz Medical Campus · Aurora, Colorado
- Yale Cancer Center · New Haven, Connecticut
- The University of Chicago Medical Center (UCMC) · Chicago, Illinois
- University of Maryland School of Medicine · Baltimore, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify