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

NCT04270864 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-10-18

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Ipilimumab

20mg (4mL) IT

DRUG

Nivolumab

360mg IV then 480mg IV

DRUG

Tilsotolimod

8 mg (2mL) IT

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2021-07-13
Completion
2023-09-25

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04270864 on ClinicalTrials.gov