Trial intelligence / Profile preview

Selinexor +/- Pembrolizumab vs SOC in mCRC

NCT04854434Phase 2

Key facts

Status: Terminated
Start: Jun 2021
Primary completion: Jun 2022
Countries: 1
Sponsor: Karyopharm Therapeutics Inc.
Modality: Small Molecules

Drugs: selinexor
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, randomised, open-label trial of selinexor in metastatic colorectal cancer (mCRC) (3 arms), sponsored by Karyopharm Therapeutics Inc. Primary endpoint: Progression-Free Survival up to 8 months. Started Jun 2021; status: terminated.

Design

3 arms

Study design: RandomizedOpen-label

Selinexor Monotherapy
Selinexor 80 mg QW
Selinexor + Pembrolizumab
Selinexor 80 mg QW + Pembrolizumab 400 mg Q6W
Standard of Care
Trifluridine and Tipiracil (Lonsurf)

Who it enrols

Patients with unresectable metastatic colorectal cancer with a known RAS mutation who have received 2-3 prior lines of therapy. Patients with MSI-H or dMMR are excluded.

Endpoints

Primary

Progression-Free Survivalup to 8 months

Secondary

Overall Survivalup to 8 months
Overall Response Rateup to 8 months
Progression-Free Survival at 6 Months6 months
Overall Survival at 6 Months6 months
Overall Survival at 12 Months12 months
Duration of Responseup to 8 months
Disease Control Rateup to 8 months
Treatment-emergent Adverse Eventsup to 12 months

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