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Brief Title: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
Official Title: Phase 2/3, Randomized Study of OX40 Agonist INBRX-106 With Pembrolizumab vs Pembrolizumab as First Line Treatment for Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1(CPS ≥20)
Study ID: NCT06295731
Brief Summary: This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Medical Center, Duarte, California, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States
Name: Clinical Lead
Affiliation: Inhibrx, Inc.
Role: STUDY_DIRECTOR