drugset
drugset / Trial / NCT03982121

Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy

NCT03982121 ↗

Phase 1 Withdrawn Gustave Roussy, Cancer Campus, Grand Paris
Non-randomizedSingle-groupOpen-labelTreatment

Summary

To determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D) and the toxicity profile (NCI CTCAE v5.0 and immune related adverse events) of i.t. administration of anti-CTLA4 antibody (ipilimumab) and TLR4 agonist (synthetic glucopyranosyl lipid A formulated in a stable emulsion \[GLA-SE\]) in colorectal LM (CRLM) in combination with intravenous (i.v.) administration of anti-PD-1 antibody (nivolumab) and chemotherapy (FOLFOX regimen).

Timeline

Start
2019-06-04
Primary completion
2020-02-12
Completion
2020-02-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GLA-SE Other / unclassified 1 ug Other
Subject GLA-SE Other / unclassified 2 ug Other
Subject GLA-SE Other / unclassified 5 ug Other
Subject GLA-SE Other / unclassified 10 ug Other
Subject GLA-SE Other / unclassified 20 ug Other
Subject Ipilimumab Monoclonal antibody 5 mg Other
Subject Ipilimumab Monoclonal antibody 10 mg Other
Subject Ipilimumab Monoclonal antibody 25 mg Other
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Background Leucovorin Small molecule 200 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

colorectal cancer