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Treatment of high-risk non-muscle infiltrating bladder tumors with IMUNO BCG Moreau RJ as prophylaxis for recurrence and progression.
THE OBJECTIVE OF THE STUDY IS TO MEASURE HOW LONG THE TUMOR REMAINS STABLE, WITHOUT WORSENING, AFTER ADMINISTRATION OF THE TREATMENT UNDER STUDY (PROGRESSION-FREE SURVIVAL). IN ADDITION, WE WILL ALSO INVESTIGATE OTHER SECONDARY OBJECTIVES SUCH AS HOW LONG IT WILL BE IF THE TUMOR RECURS AFTER CURE (DISEASE-FREE SURVIVAL), HOW YOU NOTICE THAT YOUR LIFE IMPROVES WITH THE TREATMENT (QUALITY OF LIFE) AND ITS SAFETY (ADVERSE REACTIONS AND RATE OF WITHDRAWALS DUE TO TOXICITY). FINALLY, WE ALSO WANT TO STUDY HOW YOUR BODY RECOGNIZES AND DEFENDS ITSELF AGAINST THE TREATMENT WE ARE GOING TO ADMINISTER (IMMUNE RESPONSE). (IMMUNE RESPONSE).
Technical Summary
- TREATMENT OF HIGH-RISK NON-MUSCLE INFILTRATING BLADDER TUMORS WITH IMUNO BCG MOREAU RJ AS PROPHYLAXIS FOR RECURRENCE AND PROGRESSION.
- Code EudraCT: 2017-002928-24
- Protocol number: ENCORE-01
- Promoter: Biofabri
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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