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.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

1. Aged at least 18 years.
2. HLA type: HLA-A*02-positive
3. Metastatic and/or locally advanced RCC with clear cell histology
4. Measurable and/or non-measurable tumor lesions as per RECIST 1.1 based on the local assessment.
5. Patients who are candidates for a first-line therapy with sunitinib.
6. Favorable or intermediate risk according to the 6-score risk criteria in patients treated with VEGF-targeted agents according to Heng [Heng et al. 2009].
7. Able to understand the nature of the study and give written informed consent.
8. Willingness and ability to comply with the study protocol for the duration of the study.
9. Female patients who are post menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or practice an medically acceptable methods of birth control
10. Male patients willing to use contraception (condoms with spermicidal jellies or cream) upon study entry and during the course of the study or have undergone vasectomy.

Exclusion Criteria

1. Prior systemic therapy for metastatic disease.
2. History of or current brain metastases.
3. Abnormal >= CTC Grade 3 laboratory values at Screening 2
4. Metastatic second malignancy.
5. Localized second malignancy expected to influence the patient*s life span.
6. Patients with a history or evidence of systemic autoimmune disease
7. Known active hepatitis B or C infection.
8. Known HIV infection.
9. Active infections requiring oral or intravenous antibiotics.
10. Any other known infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patients* blood or tissue.
11. Received study drug within any clinical study (including approved and experimental drugs) within 4 weeks before sunitinib start.
12. Serious intercurrent illness, which according to the investigator, poses an undue risk for the patient when participating in the trial,
13. Less than 12 months since any of the following:
• Myocardial infarction,
• Severe or unstable angina,
• Coronary or peripheral artery bypass graft,
• Cerebrovascular event incl. transient ischemic attack,
• Pulmonary embolism / deep vein thrombosis (DVT).
14. Pregnancy or breastfeeding.
15. Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Overall survival (OS), comparing patients receiving or not vaccination<br /><br>therapy with IMA901 in addition to first-line therapy with sunitinib</p><br>

Secondary Outcome Measures

Name	Time	Method

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