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Withdrawn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

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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