Durvalumab in combination with chemoradiotherapy in patients with head and neck squamous cell carcinoma: Results from the Phase 1 CLOVER study

• Published in: Head & neck 2024-05, Vol.46 (5), p.1152-1159
• Main Authors: Bauman, Julie E., Karam, Sana D., O'Brien, Cathy, Mak, Gabriel, Cho, Byoung Chul
• Format: Article
• Language: English
• Subjects: Chemoradiotherapy; Cisplatin; CLOVER; Disease control; durvalumab; Head & neck cancer; Head and neck carcinoma; HNSCC; Lymphopenia; Phase 1; Solid tumors; Squamous cell carcinoma; Stomatitis
• ISSN: 1043-3074; 1097-0347; 1097-0347
• DOI: 10.1002/hed.27726

Background The Phase 1 CLOVER study (NCT03509012) assessed durvalumab in combination with concurrent chemoradiotherapy (cCRT) in patients with advanced solid tumors; we report results from the head and neck squamous cell carcinoma (HNSCC) cohort. Methods Patients with histologically/cytologically confirmed locally advanced HNSCC, eligible for definitive cCRT and not considered for primary surgery, received durvalumab plus cisplatin and concurrent external beam radiation. Objectives were to assess safety/tolerability and preliminary efficacy. Results Eight patients were enrolled. The most frequent any‐cause adverse events (AEs) were nausea and radiation skin injury (each n = 5); most frequent grade 3/4 AEs were lymphopenia and stomatitis (each n = 3). No patients had dose‐limiting toxicities. Objective response rate was 71.4% (5/7 patients; four complete responses, one partial response); disease control rate was 85.7% at 18 weeks and 83.3% at 48 weeks. Conclusions Durvalumab plus cCRT was tolerable and active in patients with unresected, locally advanced HNSCC.