Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma

Part of paid clinical trials in Sacramento, California.

Sponsor
Mamta Parikh
Study ID
NCT04856189
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Urothelial Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Refractory Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Selinexor — DRUG
    Given PO

Study Details

This phase Ib/II trial finds the best dose of selinexor and its effect with pembrolizumab in treating patients with urothelial carcinoma that are not eligible to receive the chemotherapy drug cisplatin, or have been given cisplatin and the cancer has gotten worse. Patients must also have urothelial carcinoma that has spread locally, near where it started (locally advanced), or has spread to other parts of the body (metastatic). Selinexor may stop the growth of tumor cells by blocking a protein, called XPO1, that is needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving selinexor and pembrolizumab may kill more tumor cells.

Key Dates

Start date
Apr 8, 2021
Status verified
Jan 2026
Primary completion
Jan 4, 2024
Completion
Feb 13, 2024

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) (Phase Ib) [ Time Frame: Up to 2 cycles (each cycle is 21 days); up to about 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

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By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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