IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
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.
Metastatic Renal Cell Carcinoma
Biological: IMA901 plus GM-CSF
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma|
- Overall survival [ Time Frame: 2015 (estimated) ] [ Designated as safety issue: No ]
- Overall survival in biomarker-defined subgroup [ Time Frame: 2015 (estimated) ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
- Best tumor response [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: continuously ] [ Designated as safety issue: Yes ]
- Cellular immunomonitoring [ Time Frame: 2014 (estimated) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Sunitinib||
as per label
Other Name: Sutent
|Experimental: IMA901 plus GM-CSF added to sunitinib||
Biological: IMA901 plus GM-CSF
After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant will be applied for a period of 4 months while continuing treatment with sunitinib
Other Names:Drug: Cyclophosphamide
One single low-dose i.v. infusion prior to the first vaccination
This is a multicenter, open-label, randomized phase III study to investigate whether therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong overall survival in patients with metastatic and/or locally advanced RCC when added to standard first-line therapy with sunitinib (primary endpoint).
Secondary endpoints include a subgroup analysis of overall survival in patients who are positive for a prospectively defined primary biomarker signature (identified as being predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase II study), progression-free survival (PFS), best overall response, cellular immunomonitoring in a subset of patients, and safety. Safety analysis will be based on adverse events (AEs), physical examinations, vital signs, hematology, clinical chemistry, urinalysis and ECG changes.
Further endpoints include subgroup analyses of overall survival in patients who are positive for further prospectively defined biomarkers (identified in the previous phase II study), and exploratory screening of new biomarkers (to be investigated in patients' blood and paraffin sections from tumor tissue) to predict better clinical outcome as response to vaccination with IMA901. Biomarker sets will not be used for patient selection in this study.
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|Principal Investigator:||Brian Rini, MD||Cleveland Clinic Taussig Cancer Institute|
|Principal Investigator:||Tim Eisen, MD||Addenbrooke's Hospital University of Cambridge, UK|