A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Phase 1/2
287
about 8.7 years
18+
14 sites in CA, CO, CT +9
What this study is about
Researchers are testing the safety and effectiveness of amivantamab, either alone or with other treatments like pembrolizumab, paclitaxel, or carboplatin, in people with recurrent or metastatic head and neck cancer. The trial will also determine the best dose of amivantamab when used with paclitaxel for patients who are undergoing surgery.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Amivantamab
- 2.Receive Pembrolizumab
- 3.Take Carboplatin
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
amivantamab, carboplatin, paclitaxel (Taxane chemotherapy; stabilizes microtubules), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
injection, intravenous, infusion
Primary: Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT), Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity, Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
Secondary: Cohort 1 and 4: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab, Cohort 1 and 4: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab, Cohort 1 and 4: Maximum Observed Serum Concentration (Cmax) of Amivantamab, Cohort 1 and 4: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab, Cohort 6: Event-Free Survival (EFS), Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR), Cohorts 1, 2, 3B, 4 and 5: Progression-free Survival (PFS), Cohorts 1, 2, 3B, 4, 5 and 6: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
Oncology