NCT04270864

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

A Phase I Trial Assessing the Safety and Efficacy of an Anti-tumor Immunity Priming Strategy Combining Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Ipilimumab	20mg (4mL) IT
DRUG	Nivolumab	360mg IV then 480mg IV
DRUG	Tilsotolimod	8 mg (2mL) IT

Timeline

• Start date: 2020-04-10
• Primary completion: 2021-07-13
• Completion: 2023-09-25
• First posted: 2020-02-17
• Last updated: 2024-10-18

Locations

1 site across 1 country: France