Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT04856189|
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Metastatic Urothelial Carcinoma Refractory Urothelial Carcinoma||Biological: Pembrolizumab Drug: Selinexor||Phase 1 Phase 2|
I. To determine the recommended phase 2 dose (RP2D) of selinexor in combination with standard-dose pembrolizumab in patients with advanced urothelial carcinoma who are cisplatin-ineligible or platinum-refractory. (Phase Ib) II. To determine the objective response rate (ORR) of selinexor in combination with pembrolizumab in patients with advanced urothelial carcinoma who are cisplatin-ineligible or platinum-refractory. (Phase II)
I. To further evaluate the toxicity profile of the combination of selinexor with pembrolizumab in patients with advanced urothelial carcinoma.
II. To further evaluate the efficacy of the combination of selinexor with pembrolizumab in patients with advanced urothelial carcinoma as defined by progression-free survival (PFS).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of Selinexor Plus Pembrolizumab in Cisplatin-Ineligible or Cisplatin-Refractory Patients With Advanced Urothelial Carcinoma|
|Actual Study Start Date :||April 8, 2021|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2024|
Experimental: Treatment (selinexor, pembrolizumab)
Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
- Recommended phase 2 dose (RP2D) (Phase Ib) [ Time Frame: Up to 2 cycles (each cycle is 21 days) ]Defined by dose-limiting toxicity (DLTs). Dose limiting toxicities will be listed according to dose level. Separately by dose level and the expansion cohort (as well as for the total RP2D cohort), adverse events (AEs) will be summarized as number of patients according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 term and grade, where grade is the maximum across a patient's treatment period.
- Objective response rate (ORR) (Phase II) [ Time Frame: Up to 2 years ]ORR, calculated as the total number of patients with a confirmed complete response or partial response, will be reported as a percentage of total evaluable patients. Response will be reported using Response Evaluation Criteria in Solid Tumor 1.1 definitions. ORR will be summarized by exact binomial 95% confidence intervals (CI).
- Incidence of grade 3 or higher AEs [ Time Frame: Up to 2 years ]Defined by NCI CTCAE version 5. The number (%) of patients who experience >= 1 grade 3-5 AEs will be reported, as well as the proportion with exact binomial 95% CI.
- Progression-free survival (PFS) [ Time Frame: From enrollment to trial to time of disease progression or death from any cause, assessed up to 2 years ]Assessed with Kaplan-Meier plot and estimate of median PFS with 95% CI.
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): NCT04856189
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Mamta Parikh, MD 916-734-3771 email@example.com|
|Principal Investigator: Mamta Parikh, MD|
|Principal Investigator:||Mamta Parikh||University of California, Davis|