Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers
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
Timeline
- Start
- 2020-04-10
- Primary completion
- 2021-07-13
- Completion
- 2023-09-25
Outcome
Outcome not reported
Stopped: “The part A of the trial has been completed according to the protocol. The part B has not been opened because of unfeasibility (experimental products not yet available).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 20 mg | Other |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Tilsotolimod | Unknown | 8 mg | Other |
Indications
No indication recorded.