A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)
Purpose
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.
Condition
- Head and Neck Squamous Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 participants 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 participants with primary oropharyngeal cancer. - A baseline new tumor sample unless the participant 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)
Exclusion Criteria
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization. - Known leptomeningeal involvement - Any systemic anticancer therapy within 4 weeks prior to randomization. - Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization. - Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies - History of hypersensitivity reaction to any of the excipients of treatment required for this study. - Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry - History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer) - Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy - Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders - Participants with known infectious diseases (as per protocol) - Pregnant or breastfeeding participants - Participant has a primary tumor site of nasopharynx (any histology).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MCLA-158 |
|
|
|
Active Comparator Investigator's Choice |
|
Recruiting Locations
Site 67
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Merus B.V.
Detailed Description
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.