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
- Conditions
- The 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: 13.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 13.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-022459-45-GB
- Lead Sponsor
- immatics biotechnologies GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 339
1. Aged at least 18 years 2. HLA type: HLA-A*02-positive (assessed by a central laboratory, the result of HLA-testing will be available within a maximum of 5 days) 3. Metastatic and/or locally advanced RCC with clear cell histology (histological confirmation by local pathologist required). NOTE: prior nephrectomy is NOT required. 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). Laboratory values for risk categorization will be determined by a central laboratory. The subject has a favorable risk if none, or intermediate risk if one or two of the following criteria apply (if three or more criteria apply the subject is not eligible): a. Hemoglobin < LLN b. Serum corrected calcium > ULN c. Karnofsky performance status < 80% d. Time from initial diagnosis to initiation of therapy < 1 year e. Absolute neutrophil count > ULN f. Platelets > ULN 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 one of the following medically acceptable methods of birth control: • Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before study entry. • Intrauterine device (IUD). • Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream). 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Prior systemic therapy for metastatic disease. (Note: prior adjuvant treatment for non-metastatic disease is allowed, however adjuvant therapy must have been stopped = 1 year before Visit C). 2. History of or current brain metastases. 3. Abnormal = CTC Grade 3 laboratory values at screening 2 (assessed by a central laboratory) 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, e.g. rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome 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. Examples are: rabies, mycobacterium leprae, plasmodium falciparum, coccidiodes immitis. 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, including, but not limited to, any of the following: • Clinically significant cardiovascular disease (e.g., uncontrolled hypertension; clinically significant cardiac arrhythmia, clinically significant QT-prolongation), • New York Heart Association class III-IV congestive heart failure • Symptomatic peripheral vascular disease • Severe pulmonary dysfunction • Psychiatric illness or social situation that would preclude study compliance 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method