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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT04270864
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    20mg (4mL) IT
  • Nivolumab — DRUG
    360mg IV then 480mg IV
  • Tilsotolimod — DRUG
    8 mg (2mL) IT

Study Details

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

Key Dates

Start date
Apr 10, 2020
Status verified
Oct 2024
Primary completion
Jul 13, 2021
Completion
Sep 25, 2023

Study Design

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

Arms

  • Experimental: Regimen A1
    Combination between nivolumab IV Q3W and dual intratumoral injections of Ipilimumab and Tilsotolimod Q3W
  • Experimental: Regimen A2
    Combination between nivolumab IV Q3W and dual intratumoral injections of Ipilimumab and Tilsotolimod QW

Primary Outcome Measure

Describe the incidence of Dose-intensity limiting toxicities [ Time Frame: during a 28 days period after Cycle 1Day 1 (each cycle is 28 days) ]

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