A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies

Phase 1/2 Completed 97 enrolled MedImmune LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

Timeline

Start: 2014-05-19
Primary completion: 2020-03-17
Completion: 2020-03-17

Outcome

Missed primary endpoint

registry analysis (superiority test); MEDI0680 20 mg/kg vs Nivolumab 240 mg; p = 0.5494; Rate difference -23.8 (95% CI -72.8 to 31.1); Fisher Exact NCT02118337 ↗

Publications

Voss MH, Azad AA, Hansen AR, Gray JE, Welsh SJ, Song X, Kuziora M, Meinecke L, Blando J, Achour I, Wang Y, Walcott FL, Oosting SF. A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Clin Cancer Res. 2022 Jul 15;28(14):3032-3041. doi: 10.1158/1078-0432.CCR-21-4115.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	3 mg	Intravenous
Subject	Durvalumab	Monoclonal antibody	10 mg	Intravenous
Subject	Durvalumab	Monoclonal antibody	750 mg	Intravenous
Subject	MEDI0680	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	MEDI0680	Monoclonal antibody	0.5 mg/kg	Intravenous
Subject	MEDI0680	Monoclonal antibody	2.5 mg/kg	Intravenous
Subject	MEDI0680	Monoclonal antibody	10 mg/kg	Intravenous
Subject	MEDI0680	Monoclonal antibody	20 mg/kg	Intravenous
Comparator	Nivolumab	Monoclonal antibody	240 mg	Intravenous