Phase I/II Trial of Durvalumab plus Tremelimumab and Stereotactic Body Radiotherapy for Metastatic Head and Neck Carcinoma.

Authors

Houda Bahig, Run Zhou Ye, Francine Aubin, Phuc Felix Nguyen-Tan, Denis Soulieres, Brock John Debenham, Danielle Charpentier, David A Palma, Neil Chua, Eric Winquist, Rahima Jamal, Khalil Sultanem, Olivier Ballivy, Edith Filion, John Mathew, Manjula Maganti, Philip Wong

Published in

International journal of radiation oncology, biology, physics. Aug 12, 2026. Epub Aug 12, 2026.

Abstract

This multi-institutional phase I/II study evaluated the safety and efficacy of tremelimumab (T) and durvalumab (D) in combination with stereotactic body radiotherapy (SBRT) in oligometastatic head and neck squamous cell carcinoma (HNSCC) (ClinicalTrials.gov identifier: xxxxxx).
Patients with oligometastatic HNSCC (2-10 lesions) received D (1500 mg) and T (75 mg) for four monthly cycles, followed by D monotherapy for an additional eight monthly cycles. SBRT was administered to 2-5 lesions during cycle 2. In phase I, the primary endpoint was safety, while in phase II, the primary endpoint was 6-month progression-free survival (PFS). Secondary endpoints included local control, out of SBRT field objective response rate, and overall survival (OS).
Thirty-three evaluable patients were recruited (accrual interrupted by COVID-19). Patients had received 1, 2, and 3 prior lines of systemic therapy in 48%, 21%, and 9% of cases, respectively. The median SBRT dose was 45 Gy (range: 18-50) in 3-5 fractions. There were 9 Grade 3-4 AEs related to D and T, occurring in 7 (21%) patients. One patient experienced a Grade 5 AE due to SBRT (radionecrosis following mucosal re-irradiation); no other Grade 3-5 AEs were attributed to SBRT or the SBRT-immunotherapy combination. Median PFS was 12.8 months (95% CI: 7.17-27.2) with a 6-month PFS of 72.7% (95% CI: 59.0-89.6), while median OS was 28.4 months (95% CI: 22.9-38.9).
Dual-checkpoint inhibition combined with SBRT was well tolerated and led to promising 6-month PFS, meeting both safety and primary endpoints.

PMID:
42586218
Bibliographic data and abstract were imported from PubMed on 13 Aug 2026.

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