TroVax Renal Immunotherapy Survival Trial

Phase 3 Completed 733 enrolled Oxford BioMedica Sanofi · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma.

Timeline

Start: 2006-09
Primary completion: 2009-12
Completion: 2009-12

Outcome

Missed primary endpoint

paper No significant difference in overall survival was evident in the two treatment arms (median 20.1 months MVA-5T4 versus 19.2 months placebo; P = 0.55). PMID 20881001 ↗

Publications

Results Amato RJ, Hawkins RE, Kaufman HL, Thompson JA, Tomczak P, Szczylik C, McDonald M, Eastty S, Shingler WH, de Belin J, Goonewardena M, Naylor S, Harrop R. Vaccination of metastatic renal cancer patients with MVA-5T4: a randomized, double-blind, placebo-controlled phase III study. Clin Cancer Res. 2010 Nov 15;16(22):5539-47. doi: 10.1158/1078-0432.CCR-10-2082. Epub 2010 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TroVax	Vaccine	1 ml	Intramuscular
Background	IL-2	Protein / enzyme biologic	—	Subcutaneous
Background	Interferon-α	Protein / enzyme biologic	—	—
Background	Sunitinib	Small molecule	—	—