Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers

• Status: Active, not recruiting
• Trial end date: 2026-02-01

Summary

Open label, phase Ib study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab.

The trial will be divided into two parts:

PART A:

the first part will assess the safety of two regimen and will recruit patients with all types of injectable solid malignancies

PART B:

the second part will include 3 expansion cohorts of 15 patients:

• B1: anti-PD-1 refractory advanced NSCLC cohort

• B2: anti-PD-1 refractory advanced melanoma cohort

• B3: immunotherapy naïve microsatellite stable colorectal cancer (MSS CRC) cohort

• Phase: Phase 1

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Ipilimumab; Nivolumab