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- Title
Durvalumab in combination with chemoradiotherapy in patients with head and neck squamous cell carcinoma: Results from the Phase 1 CLOVER study.
- Authors
Bauman, Julie E.; Karam, Sana D.; O'Brien, Cathy; Mak, Gabriel; Cho, Byoung Chul
- Abstract
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.
- Subjects
SQUAMOUS cell carcinoma; CLOVER; LYMPHOPENIA; RADIATION injuries; CHEMORADIOTHERAPY; SKIN injuries
- Publication
Head & Neck, 2024, Vol 46, Issue 5, p1152
- ISSN
1043-3074
- Publication type
Article
- DOI
10.1002/hed.27726