Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy
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|ClinicalTrials.gov Identifier: NCT03319745|
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stage I Bladder Cancer AJCC v8 Stage II Bladder Cancer AJCC v8 Stage III Bladder Cancer AJCC v8 Stage IIIA Bladder Cancer AJCC v8 Stage IIIB Bladder Cancer AJCC v8||Biological: Pembrolizumab||Phase 2|
I. To characterize the safety profile of pembrolizumab in patients with urothelial carcinoma undergoing radical cystectomy.
I. To explore a signal of anti-cancer immunological activity by evaluating surgical specimens for evidence of post-treatment lymphocytic infiltration and residual tumor compared to pre-treatment biopsy samples.
II. To explore a signal of biomarker activity by evaluating surgical specimens and blood samples for established and not-so-established markers of response to pembrolizumab.
III. To report the tumor yield and sufficiency of tumor for immunological and biomarker activity.
IV. To examine the interaction of the human microbiome and pathologic response to pembrolizumab.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
After completion of study treatment, patients are followed up to 30 and 90 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Window of Opportunity Phase II Study of Pembrolizumab in Patients With Bladder Cancer Undergoing Radical Cystectomy|
|Actual Study Start Date :||January 11, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. About 4 weeks after treatment, patients then undergo radical cystectomy per standard of care.
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 [ Time Frame: Up to 30 days post-surgery ]Toxicity of concern (TOX) will be monitored using the methods of Thall et al. TOX events will be reported with a 95% credible interval assuming a non-informative prior of beta. Specific events will also be summarized. All adverse events and surgical complications will be reported overall by grade, attribution, and treatment period.
- Biomarker activity of Pembrolizumab in Patients with Bladder Cancer Undergoing Radical Cystectomy [ Time Frame: Baseline up to 90 days after surgery ]Tissue evaluated for signals of biomarker activity by evaluating surgical specimens for established and not-so-established markers of response to pembrolizumab (e.g. TILS, PD-1 and PD-L1 levels) compared to pre-treatment biopsy samples.
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): NCT03319745
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Neema Navai||M.D. Anderson Cancer Center|