NCT04850755

A Phase I Dose Escalation Study of Selinexor Plus Nivolumab and Ipilimumab in Advanced/Metastatic Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advance Solid Malignancies
• Metastatic Solid Malignancies

Interventions

Type	Name	Description
DRUG	Selinexor in combination with nivolumab and ipilimumab	Patients will commence at dose level 1. One cycle is 42 days (6 weeks) for all three agents. At dose level 1, selinexor will be dosedorally weekly, and nivolumab at 2 weekly + ipilimumab 1mg/kg 6 weekly. Patients can have dosing interruptions or reductions of any drug independently of one another, depending on the drug causing the toxicity

Timeline

• Start date: 2021-03-08
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2021-04-20
• Last updated: 2025-09-25

Locations

1 site across 1 country: Singapore