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

Conditions

• Advance Solid Malignancies
• Metastatic Solid Malignancies

Eligibility Criteria

Sex

ALL

Age

21 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Selinexor in combination with nivolumab and ipilimumab — DRUG
  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

Study Details

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.

Key Dates

Start date

Mar 8, 2021

Status verified

Sep 2025

Primary completion

Mar 17, 2025

Completion

Mar 17, 2025

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: patients with advanced solid malignancies
  Patients will be dosed with selinexor once a week continuously in a 6 week cycle. Nivolumab will be administered on biweekly of each cycle . Ipilimumab will be dosed only on D1 of each cycle . Ipilimumab will continue for a maximum of 4 cycles. Nivolumab and selinexor will continue for up to 24 months or until discontinuation criteria is met.

Primary Outcome Measure

Objective disease response assessment [ Time Frame: 3 years ]