EUCTR2010-022459-45-DE
Active, not recruiting
Not Applicable
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
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- immatics biotechnologies GmbH
- Enrollment
- 330
- Status
- Active, not recruiting
- Last Updated
- 10 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
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
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 for hematology (Hb, WBC, neutrophils, lymphocytes, platelets), liver (serum bilirubin, ALAT or ASAT) and renal function (serum creatinine).
- •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 patient tissues.
Outcomes
Primary Outcomes
Not specified
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