A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
Head and Neck Cancer
Unknown Primary
18 Years and older, Male and Female
MCLA-158-CL02 (primary)
NCI-2024-06206
2023-510322-32
2023-510322-32-00
Summary
This is a phase 3 open-label, randomized, controlled, multicenter study to compare
petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and
third-line treatment of incurable metastatic/recurrent disease.
Objectives
This is a phase 3 open-label, randomized, controlled, multicenter study to compare
petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and
third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have
progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy.
Patients treated with platinum-containing therapy only in the adjuvant setting, or in the
context of multimodal therapy for locally advanced disease, should have PD within 6
months of the last dose of platinum-containing therapy.
Eligibility
- Signed ICF before initiation of any study procedures.
- Age = 18 years at signing of ICF.
- Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
- HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy.
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.
- A baseline new tumor sample unless the patient has an available tumor sample as an FFPE block with sufficient material.
- Measurable disease as defined by RECIST v1.1 by radiologic methods.
- ECOG PS of 0 or 1
- Life expectancy = 12 weeks, as per investigator
- Adequate organ function (as per protocol)
Treatment Sites in Georgia
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