A Study Comparing Nivolumab and Intravesical BCG to BCG Alone in High-risk Non-muscle Invasive Bladder Cancer
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2019-002567-96-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 875
_Signed Written Informed Consent;
_Histologically confirmed persistent or recurrent high-risk non-muscle-invasive UC (TaHG and/or T1 and/or CIS);
_Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses);
_Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
_Males and females, ages 18 or age of majority, and older;
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 219
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 656
_Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured or not requiring treatment;
_Patients with serious or uncontrolled medical disorders;
_Participants with an active, known, or suspected autoimmune disease;
_Recurrent high-risk NMIBC that is classified as BCG unresponsive;
_Has any contraindication to intravesical BCG therapy, including evidence of active tuberculosis;
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