Clinical Trials Logo

Clinical Trial Summary

This is a single-centre, phase 1a (dose escalation) and 1b (dose expansion) study to evaluate the safety and tolerability of oral Selinexor in combination with nivolumab and ipilimumab in patients with advanced solid malignancies.


Clinical Trial Description

Primary Objectives - To evaluate the safety and tolerability of selinexor in combination with nivolumab and ipilimumab - To determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of selinexor in combination with nivolumab and ipilimumab in patients with advanced or metastatic solid tumor malignancies. Secondary Objectives - To determine Selinexor pharmacokinetics (PK) in Asian patients - To describe anti-tumor responses with the combination in patients with advanced or metastatic solid tumor malignancies. Exploratory Objectives - To assess the immunomodulatory effects of selinexor in solid tumour malignancies and circulating immune cells - To identify biomarkers of response to the combination of selinexor and nivolumab + ipilimumab. We will explore changes in PDL1 expression, T cell infiltration (including CD4 and CD8 positive cells), gene expression profiles on serial tumor biopsies pre-selinexor, post-selinexor alone, and after the combination of selinexor and ipilimumab + nivolumab where feasible. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04850755
Study type Interventional
Source National University Hospital, Singapore
Contact David Shao Peng Tan
Phone 6772 4661
Email David_SP_Tan@nuhs.edu.sg
Status Recruiting
Phase Phase 1
Start date March 8, 2021
Completion date November 2024

See also
  Status Clinical Trial Phase
Withdrawn NCT02439723 - Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients Phase 1
Completed NCT03107663 - ⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma Phase 1
Withdrawn NCT02705703 - Consolidation Therapy in Patients With Metastatic Solid Malignancies Phase 1/Phase 2