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Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma

Phase 1
Recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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