Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder
NCT02662309 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2025-03-10
Summary
ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include extensive biomarker work on samples from these patients. Eligible patients will receive two 3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed up for safety, survival, and disease data.
Conditions
Interventions
- DRUG
-
MPDL3280A
Intravenous infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
Queen Mary University of London
lead OTHER
Principal Investigators
-
Thomas Powles, MBBS MD MRCP · Queen Mary University of London
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-01
- Primary Completion
- 2020-06-11
- Completion
- 2020-06-11
Countries
- France
- Netherlands
- Spain
- United Kingdom
Study Locations
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