A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer
Phase 3
500
about 3.5 years
18+
31 sites in AZ, CA, CT +15
What this study is about
This trial is testing a treatment with amivantamab added to standard chemotherapy compared to standard chemotherapy alone for people with recurrent or metastatic head and neck cancer. The goal is to see if the combination of treatments helps fight the cancer better.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Amivantamab
- 2.Receive Pembrolizumab
- 3.Take 5-Flurouracil
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
amivantamab, carboplatin, cisplatin (Platinum chemotherapy; crosslinks DNA to stop replication), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
injection, intravenous, infusion
Primary: Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR), Overall Survival (OS)
Secondary: Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30, Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30, Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores, Duration of Response (DOR) As Assessed by BICR, Number of Participants with Laboratory Abnormalities, Number of Participants with Treatment-Emergent Adverse Events (TEAEs), ORR as Assessed by Investigator, Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score
Oncology