Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder (ABACUS)
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|ClinicalTrials.gov Identifier: NCT02662309|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2016
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: MPDL3280A||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Investigating Preoperative MPDL3280A in Operable Transitional Cell Carcinoma of the Bladder (ABACUS)|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2020|
Patients receive 2x 3-weekly cycles of MPDL3280A (one infusion on the first day of each cycle) prior to cystectomy surgery.
Other Name: Atezolizumab
- Efficacy of MPDL3280A pre-cystectomy with respect to pathological complete response rate (pCRR) [ Time Frame: 2-3 months (timeframe dependent on delay to surgery) ]Pathological complete response rate defined as no microscopic evidence of residual disease in the bladder based on histological evaluation of the resected bladder specimen collected during cystectomy (post-treatment).
- Efficacy of MPDL3280A pre-cystectomy with respect to anti-tumour effects as measured by radiological response (RR) [ Time Frame: Approx 34 weeks (timeframe dependent on delay to pre-cystectomy visit) ]CT or MRI scan taken at screening and pre-cystectomy visits. RR is defined as a >30% decrease in tumour diameter from the baseline scan.
- Efficacy of MPDL3280A pre-cystectomy with respect to anti-tumour effects based on disease free survival (DFS) [ Time Frame: Up to 2 years post-cystectomy ]Disease and survival data is reviewed at post-surgery visits and at 1 and 2 years post-cystectomy.
- Efficacy of MPDL3280A pre-cystectomy with respect to anti-tumour effects based on overall survival (OS) [ Time Frame: Up to 2 years post-cystectomy ]Disease and survival data is reviewed at post-surgery visits and at 1 and 2 years post-cystectomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662309
|Principal Investigator:||Thomas Powles, MBBS MD MRCP||Queen Mary University of London|