NL-OMON36272
Completed
Phase 3
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. - IMA901 in patients receiving sunitinib for advanced/metastatic RCC
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- kidney cancer
- Sponsor
- immatics biotechnologies, GmbH
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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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 - IMA901 in patients receiving sunitinib for advanced/metastatic RCCThe study population consists of HLA-A*02-positive metastatic and/or locally advanced RCC patients with histology of the clear-cell type who are aged 18 years or older and have a favorable or intermediate risk according to the 6-score Heng criteria (Heng et al, 2009). Patients must be planned to receive standard first-line therapy with sunitinib irrespective of their participation in the trial.MedDRA version: 14.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-022459-45-HUimmatics biotechnologies GmbH339
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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 - IMA901 in patients receiving sunitinib for advanced/metastatic RCCThe study population consists of HLA-A*02-positive metastatic and/or locally advanced RCC patients with histology of the clear-cell type who are aged 18 years or older and have a favorable or intermediate risk according to the 6-score Heng criteria (Heng et al, 2009). Patients must be planned to receive standard first-line therapy with sunitinib irrespective of their participation in the trial.MedDRA version: 12.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedMedDRA version: 12.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2010-022459-45-NLimmatics biotechnologies GmbH339