Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

Summary

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

Timeline

Start

2015-09-09

Primary completion

2018-09-10

Completion

2020-11-13

Outcome

Missed primary endpoint

registry analysis (superiority test); Durvalumab + Tremelimumab vs Standard of Care (SoC); p = 0.7624; Hazard Ratio (HR) 1.04 (95% CI 0.85 to 1.26); Log Rank NCT02369874 ↗

registry analysis (superiority test); Durvalumab vs Standard of Care (SoC); p = 0.1993; Hazard Ratio (HR) 0.88 (95% CI 0.72 to 1.08); Log Rank NCT02369874 ↗

Publications

• Ferris RL, Haddad R, Even C, Tahara M, Dvorkin M, Ciuleanu TE, Clement PM, Mesia R, Kutukova S, Zholudeva L, Daste A, Caballero-Daroqui J, Keam B, Vynnychenko I, Lafond C, Shetty J, Mann H, Fan J, Wildsmith S, Morsli N, Fayette J, Licitra L. Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study. Ann Oncol. 2020 Jul;31(7):942-950. doi: 10.1016/j.annonc.2020.04.001. Epub 2020 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	10 mg/kg	—
Subject	Durvalumab	Monoclonal antibody	20 mg/kg	—
Subject	Tremelimumab	Monoclonal antibody	1 mg/kg	—
Comparator	Cetuximab	Monoclonal antibody	—	—
Comparator	Methotrexate	Small molecule	—	—

Indications