CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
IMO-2125 +1 moredrug
Likely dose
Ipilimumab 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02644967
NCT02644967Phase 2Completed
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A Phase 1/2 Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination With Ipilimumab or Pembrolizumab in Patients With Metastatic Melanoma (ILLUMINATE-204)

Idera Pharmaceuticals, Inc.·interventional·Posted Jan 1, 2016·Updated Aug 3, 2022

In Brief

A Phase 2 clinical trial evaluating IMO-2125 and Ipilimumab for Metastatic Melanoma. Completed, enrolled 53 participants across 10 sites.

Detailed Summary

The goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when administered in combination with ipilimumab or pembrolizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 1, 2016
Enrollment StartDec 1, 2015
Primary CompletionFeb 1, 2020
Study CompletionMay 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 10.5 years ago

Interventions

IMO-2125drug

Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.

Ipilimumabdrug

4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.