NCT04854434

A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of selinexor alone or with pembrolizumab in participants with advanced or metastatic colorectal cancer (CRC). Approximately 78 participants with advanced or metastatic CRC will be enrolled, and randomized (1:1:1) into three arms A (selinexor only), B (selinexor and pembrolizumab), and C (standard of care \[Combination of trifluridine and tipiracil\]). Randomization will be based on stratification factors: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 versus 2. The end of treatment (EoT) visit will occur less than or equal to (\<=30) days post-treatment discontinuation. A survival follow-up visit will be performed every 3 months from EoT and will continue for 12 months.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Selinexor	Participants will receive selinexor oral tablets.
DRUG	Pembrolizumab	Participants will receive pembrolizumab intravenously.
DRUG	Trifluridine	Participants will receive trifluridine oral tablets as SOC.
DRUG	Tipiracil	Participants will receive tipiracil oral tablets as SOC.

Timeline

• Start date: 2021-06-29
• Primary completion: 2022-06-24
• Completion: 2022-06-24
• First posted: 2021-04-22
• Last updated: 2023-11-03
• Results posted: 2023-11-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study