Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy
Status:
Withdrawn
Trial end date:
2020-02-12
Target enrollment:
Participant gender:
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).