NCT02432846

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Mendus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients, all planned for nephrectomy, will be stratified according to the Heng risk criteria (high risk patients vs. intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax (INN: ilixadencel)+ Sunitinib or Sunitinib alone. Two doses of Intuvax (INN: ilixadencel) will be administered in to the primary tumour before nephrectomy. The control group will be scheduled for nephrectomy directly. All patients will start Sunitinib treatment 5-8 weeks after operation. Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum aktiebolag (AB) to further investigate the possibility of exploiting Intuvax (INN: ilixadencel) 10 million cells/dose when combined with Sunitinib for the treatment of mRCC patients.

Conditions

• Renal Cell Carcinoma, Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	Intuvax (INN: ilixadencel)	Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.
DRUG	Sunitinib	Cytostatic/cytotoxic drug: protein kinase inhibitor .

Timeline

• Start date: 2015-04-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2015-05-04
• Last updated: 2022-08-22
• Results posted: 2022-08-22

Locations

28 sites across 9 countries: United States, Czechia, France, Hungary, Latvia, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study