NCT04856189

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

A Phase Ib/II Study of Selinexor Plus Pembrolizumab in Cisplatin-Ineligible or Cisplatin-Refractory Patients With Advanced Urothelial Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Mamta Parikh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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) SECONDARY OBJECTIVES: 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).

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Selinexor	Given PO

Timeline

• Start date: 2021-04-08
• Primary completion: 2024-01-04
• Completion: 2024-02-13
• First posted: 2021-04-23
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study