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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT03982121
Phase
PHASE1
Status
Withdrawn

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX regimen — DRUG
    Oxaliplatin 85 mg/m² Leucovorin (LV) levogyre form (LLV) 200 mg/m² or dextro-levogyre (DL-LV) racemic mixture 400 mg/m²) Fluorouracil 2400 mg/m²
  • Nivolumab — DRUG
    Nivolumab 240 mg
  • Ipilimumab — DRUG
    Ipilimumab 5 or 10 or 25 mg
  • GLA-SE — DRUG
    GLA-SE 1 or 2 or 5 or 10 or 20 μg

Study Details

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).

Key Dates

First listed
Jun 11, 2019
Start date
Jun 4, 2019
Status verified
Feb 2020
Primary completion
Feb 12, 2020
Completion
Feb 12, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A
    FOLFOX IV + NIVOLUMAB IV
  • Experimental: B
    FOLFOX IV + GLA IT
  • Experimental: C
    FOLFOX IV + IPILIMUMAB IT
  • Experimental: D
    FOLFOX IV + NIVOLUMAB IV + GLA IT
  • Experimental: E
    FOLFOX IV + NIVOLUMAB IV + IPILIMUMAB IT
  • Experimental: F
    LFOX IV + NIVOLUMAB IV + GLA IT + IPILIMUMAB IT

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: For all the cohorts, the DLT period to determine the MTD will be 28 days ]

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