ClinicaliQ Trial Snapshot
- A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR – HN1) — Recruiting • Phase III • Oncology • NCT06525220.
- Treatment being tested: Petosemtamab (a fibroblast activation protein inhibitor) combined with pembrolizumab compared to pembrolizumab monotherapy as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.
- Patient eligibility overview: Adults with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma who have not received prior systemic therapy for their advanced disease.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : 1. Signed ICF before initiation of any study procedures 2. Age ≥ 18 years at signing of ICF 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent. 4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. 5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1. 6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting 7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material 8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods 9. ECOG Performance Status (PS) of 0-1 10. Life expectancy ≥ 12 weeks, as per investigator assessment. 11. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan 12. Adequate organ function as defined per protocol. 13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300/µl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.