IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01265901|
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : October 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: Sunitinib Biological: GM-CSF Drug: Cyclophosphamide Drug: IMA901||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||339 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Active Comparator: Sunitinib
Sunitib as Standard therapy per Label.
As per label.
Other Name: Sutent
Experimental: IMA901 plus GM-CSF added to sunitinib after single dose of cy
After 1 cycle of sunitinib, intradermal vaccinations with IMA901 plus GM-CSF as adjuvant after a single dose of cyclophosphamide will be applied for a period of 4 months while continuing treatment with sunitinib
As per label.
Other Name: SutentBiological: GM-CSF
Intradermal injection of GM-CSF as adjuvant.
Other Names:Drug: Cyclophosphamide
One single low-dose i.v. infusion prior to the first vaccination
Other Names:Drug: IMA901
Intradermal vaccinations with IMA901 vaccine.
Other Name: IMA901 Vaccine
- Overall survival [ Time Frame: 2015 (estimated) ]
- Overall survival in biomarker-defined subgroup [ Time Frame: 2015 (estimated) ]
- Progression-free survival [ Time Frame: 2014 (estimated) ]
- Best tumor response [ Time Frame: 2014 (estimated) ]
- Safety and tolerability [ Time Frame: continuously ]
- Cellular immunomonitoring [ Time Frame: 2014 (estimated) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265901
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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|