At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 88 enrolled
Drug / intervention
Intuvax (INN: ilixadencel) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients
In Brief
A Phase 2 clinical trial evaluating Intuvax (INN: ilixadencel) and Sunitinib for Renal Cell Carcinoma, Metastatic. Completed, enrolled 88 participants across 28 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma, Metastatic
CountriesCzechia, France, Hungary, Latvia, Poland, Spain, Sweden, United Kingdom, United States
CollaboratorsTFS Trial Form Support, Accelovance
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMay 2015
Primary CompletionJan 2021
TodayJul 2026
First PostedMay 4, 2015
Enrollment StartApr 1, 2015
Primary CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.2 years ago
Interventions
Intuvax (INN: ilixadencel)biological
Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.
Sunitinibdrug
Cytostatic/cytotoxic drug: protein kinase inhibitor .