A Phase 3 Trial to Compare Petosemtamab with Investigator's Choice Monotherapy in Patients with Previously Treated Head and Neck Squamous Cell Carcinoma
Phase 3
500
about 4.8 years
18+
58 sites in AL, AZ, CA +26
What this study is about
Researchers are testing whether petosemtamab, a medication, is more effective than investigator's choice monotherapy for patients who have already received treatment for head and neck squamous cell carcinoma. The trial will last approximately 1740 days and involve about 500 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Investigator's Choice
- 2.Take Petosemtamab
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.
monoclonal antibody
Primary: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review, Overall Survival (OS)
Secondary: Duration of Response (DOR) as Assessed by Blinded Independent Central Review, Duration of Response (DOR) as Assessed by Investigator Review, Mean Change From Baseline in EORTC QLQ-C30, Mean Change From Baseline in EORTC QLQ-H&N43, Number of participants Who Discontinued Study Treatment Due to TEAEs, Number of participants Who Had Dose Modification Due to TEAEs, Number of participants Who experienced At Least One Serious TEAE, Number of participants Who experienced At Least One Treatment Emergent Adverse Event (TEAE)
Oncology