A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatm… (NCT06525220) | Clinical Trial Compass
RecruitingPhase 3
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
United States700 participantsStarted 2024-09-25
Plain-language summary
This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed ICF before initiation of any study procedures
✓. Age ≥ 18 years at signing of ICF
✓. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
✓. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
✓. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.
✓. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting
✓. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
✓. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
Exclusion criteria
✕. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization
✕. Known leptomeningeal involvement
✕. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
✕
What they're measuring
1
Overall Survival (OS)
Timeframe: Up to approximately 3 years
2
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)
✕. Major surgery or radiotherapy within 3 weeks of randomization
✕. Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies
✕. History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab.
✕. 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 prior to randomization