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

Sponsor:

Merus N.V.

Sponsor Study ID:

MCLA-158-CL02

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.

eConsent:

Not available

Study Documents:

Open Study Documents
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