Sponsor: Merus N.V.
Sponsor Study ID: MCLA-158-CL02
Study Title: A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma
CTO #: 104041
NCT Number: NCT06496178
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Larynx, Lip, Oral Cavity and Pharynx
Study Objectives: To compare antitumor activity in ORR per Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines version (v) 1.1 as assessed by blinded independent central review (BICR) in patients with incurable metastatic / recurrent HNSCC patients progressed on after anti-PD-1 and platinum containing therapy, treated with petosemtamab monotherapy vs investigator s choice monotherapy. To compare OS in patients with incurable metastatic / recurrent HNSCC progressed on after anti-PD-1 and platinum-containing therapy, treated with petosemtamab monotherapy vs investigator s choice monotherapy.