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Clinical Trial Details

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Brief Title Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-risk Non-muscle-invasive Bladder Cancer (NMIBC) Participants
Official Title A PHASE Ib/II, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOLOGY OF ATEZOLIZUMAB ADMINISTERED WITH OR WITHOUT BACILLE CALMETTE-GUÉRIN IN PATIENTS WITH HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER
Principal Investigator Steinberg, Gary
Brief Summary This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV) infusion alone or in combination with intravesical BCG in high-risk NMIBC participants.
Gender Both
Ages 18 Years
Enrollment 70
Accepts Healthy Volunteers No
Lead Sponsor Hoffmann-La RocheIndustry
Collaborator
Study Design Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1/Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition High-Risk Non-Muscle-Invasive Bladder Cancer
Detail for Health Professional (on clinicaltrials.gov)
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