IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma

Summary

The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters.

Timeline

Start

2010-12

Primary completion

2015-07

Completion

2015-07

Outcome

Missed primary endpoint

paper IMA901 did not improve overall survival when added to sunitinib as first-line treatment PMID 27720136 ↗

release “The phase 3 trial did not meet its primary endpoint of showing an overall survival benefit” immatics.com ↗

Publications

• Rini BI, Stenzl A, Zdrojowy R, Kogan M, Shkolnik M, Oudard S, Weikert S, Bracarda S, Crabb SJ, Bedke J, Ludwig J, Maurer D, Mendrzyk R, Wagner C, Mahr A, Fritsche J, Weinschenk T, Walter S, Kirner A, Singh-Jasuja H, Reinhardt C, Eisen T. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Nov;17(11):1599-1611. doi: 10.1016/S1470-2045(16)30408-9. Epub 2016 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IMA901	Vaccine	4.13 mg	Other
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous
Background	GM-CSF	Protein / enzyme biologic	75 ug	Intravenous
Background	Sunitinib	Small molecule	50 mg	Oral

Indications