drugset
drugset / Trial / NCT04270864

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

NCT04270864 ↗

Phase 1 Terminated 25 enrolled Gustave Roussy, Cancer Campus, Grand Paris
Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2020-04-10
Primary completion
2021-07-13
Completion
2023-09-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 20 mg Other
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Tilsotolimod Unknown 8 mg Other

Indications

No indication recorded.