Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

Summary

The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.

Timeline

Start

2015-04

Primary completion

2021-01-31

Completion

2021-01-31

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (other test); Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) vs Sunitinib-only, Total (Both Strata); p = 0.250; Hazard Ratio (HR) 0.732 (95% CI 0.421 to 1.270); Log Rank reads as missed primary endpoint NCT02432846 ↗

registry analysis (other test); Intuvax (INN: Ilixadencel) + Sunitinib, Total (Both Strata) vs Sunitinib-only, Total (Both Strata); p = 0.240; Hazard Ratio (HR) 0.699 (95% CI 0.378 to 1.290); Log Rank reads as missed primary endpoint NCT02432846 ↗

registry analysis (other test); Intuvax (INN: Ilixadencel) + Sunitinib, High-risk vs Sunitinib-only, High-risk vs Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk vs Sunitinib-only, Intermediate-risk; p = 0.812; Log Rank reads as missed primary endpoint NCT02432846 ↗

registry analysis (other test); Intuvax (INN: Ilixadencel) + Sunitinib, High-risk vs Sunitinib-only, High-risk vs Intuvax (INN: Ilixadencel) + Sunitinib, Intermediate-risk vs Sunitinib-only, Intermediate-risk; p = 0.861; Log Rank reads as missed primary endpoint NCT02432846 ↗

release “the final median OS value in the ilixadencel treatment group has not yet been reached, indicating a survival benefit in the study’s co-primary endpoint” reads as met primary endpoint mendus.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sunitinib	Small molecule	—	—
Subject	ilixadencel	Cell therapy	1e+07 cells	Other

Indications