Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma
- Conditions
- Renal cell carcinoma
- Registration Number
- JPRN-UMIN000006938
- Lead Sponsor
- Departments of Urology and Translational Cancer Drug Development, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Not provided
1. Immunosuppressive therapy within 4 weeks before starting this therapy, e.g. corticosteroid treatment (exceptions are corticosteroid substitution therapy for adrenal insufficiency or inhalative corticosteroids for e.g. asthma) 2. History of other malignant tumors, except non-melanoma-skin cancer or curatively excised cervical carcinoma in situ 3. Presence of brain metastases on MRI or CT scan 4. Patients with a history or evidence of systemic autoimmune disease 5. Any vaccination in the two weeks before starting this therapy 6. Any planned prophylactic vaccination from study entry until the end of the induction period (5 weeks after the first vaccination) 7. Known active hepatitis B or C infection 8. Known HIV infection 9. Any of the following in the 4 weeks before starting this therapy: a) Major surgery b) Anticancer treatments including cytotoxic chemotherapy, radiotherapy, immunotherapy, hormone therapy, molecular-targeted therapy, or monoclonal antibodies c) Unresolved toxicity from prior anticancer treatments including cytotoxic chemotherapy, hormone therapy, molecular-targeted therapy, monoclonal antibodies, radiotherapy, or immunotherapy d) Received study drug within any clinical study (including approved and experimental drugs) 10. Presence of abnormal function in vital organs 11. Active infections requiring oral or intravenous antibiotics 12. Pregnancy or breastfeeding 13. Any condition which in the judgment of the investigator would place the patient inappropriate to be enrolled in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method