Trials / Completed
CompletedNCT02662309
Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder
A Phase II Study Investigating Preoperative MPDL3280A in Operable Transitional Cell Carcinoma of the Bladder (ABACUS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Queen Mary University of London · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
MPDL3280A (also called atezolizumab) is an immune check point inhibitor which targets programmed death-ligand 1 (PD-L1). Overexpression of PD-L1 prevents the immune system from eradicating cancerous cells as it blocks antigen recognition. MPDL3280A inhibits this interaction, allowing immune-mediated tumour cell killing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MPDL3280A | Intravenous infusion |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2020-06-11
- Completion
- 2020-06-11
- First posted
- 2016-01-25
- Last updated
- 2025-03-10
Locations
20 sites across 4 countries: France, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02662309. Inclusion in this directory is not an endorsement.