IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease (IMA901-202)
|ClinicalTrials.gov Identifier: NCT00523159|
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : July 10, 2012
This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma.
Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Endoxana, IMA901, Leukine Drug: IMA901 and Leukine||Phase 2|
This is a multicenter, open label, randomized phase 2 study which investigated the effect of a second-line systemic treatment with IMA901 plus GM-CSF in RCC patients. Randomization was done according to a pre-treatment with low-dose cyclophosphamide (CY). Secondary endpoints comprised tumor response parameters.
The study population consisted of HLA-A*02-positive men or women with advanced RCC of the clear-cell type classified as having a favorable or intermediate risk after first-line systemic therapy for. Patients had to be aged 18 years or older, had at least have one measurable tumor lesion and had have received first-line tyrosine kinase inhibitor or cytokine systemic therapy for advanced disease, during or after which the patient had experienced disease progression.
Patients in both arms received a total of 17 vaccinations with GM-CSF followed by IMA901 during the 9 month treatment period.
At screening baseline tumor status was assessed by CT or MRI. During the study tumor assessments were performed every 6 weeks.
Immunomonitoring (T-cell responses to peptides contained in IMA901 and analysis of other immune cell populations that may influence T-cell responses), serum levels of antibodies and molecules with suspected influence on immune response were assessed on several occasions during the study.
Safety assessment comprised continuous adverse event reporting, regular physical examinations and regular assessments of vital signs, hematology, blood chemistry and urine. A 12-lead ECG was performed at screening and at the end of the study. Pregnancy testing was performed according to applicable legislation in the country where the trial was performed. At the very least, women of childbearing potential had have to undergo a pregnancy test during screening for the study, before the first dose was applied and at the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2, Randomized, Open Label, Multicenter Study of Intradermal IMA901 Plus GM-CSF With or Without Low Dose Cyclophosphamide Pre-treatment in Advanced Renal Cell Carcinoma Patients With Measurable Disease|
|Study Start Date :||May 2007|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
Pre-treatment with a single low dose of Cyclophosphamide followed by IMA901 vaccination plus GM-CSF as adjuvant
Drug: Endoxana, IMA901, Leukine
a single i.v. infusion of Cyclophosphamid and then patients received vaccination therapy with intradermal (i.d.) injections of GM-CSF followed by i.d. injections of IMA901
No pre-treatment with Cyclophosphamide before vaccination with IMA901 and GM-CSF as adjuvant
Drug: IMA901 and Leukine
Intradermal injection of GM-CSF followed by intradermal injection of IMA901
- Disease control rate [ Time Frame: after 26 weeks ]
- Tumor response rates and SD rate [ Time Frame: after 26 and 38 weeks ]
- Duration of response [ Time Frame: from the time response is first documented until the first date of recurrence or PD ]
- Time to response [ Time Frame: From Visit c to PR or CR ]
- TTP [ Time Frame: From visit C to until tumor progression ]
- PFS and OS [ Time Frame: From visit C to tumor progression or death ]
- DCR [ Time Frame: after 38 weeks on study ]
- Immune response [ Time Frame: Visit C, 1, 5, 6, 7, 10 and 14 ]
- Effect of cyclophosphamide pre-treatment on immune response [ Time Frame: Visit C, 1, 5,6,7, 10, 14 ]
- Safety [ Time Frame: From inclusion on the study until 3 weeks after end of study visit ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523159
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|Study Director:||Alexandra Kirner, PhD||immatics Biotechnologies GmbH|