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NCT02644967 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma
A Phase 2 study, sponsored by Idera Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT02644967: Completed Phase 2 study, sponsored by Idera Pharmaceuticals.
NCT02644967 is a Phase 2 study that has completed, run by Idera Pharmaceuticals. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02644967, a Phase 2 study, has completed, sponsored by Idera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study 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.
Primary Outcome
The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population (N=44) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) The ORR for 49 evaluable (4 non-evaluable) participants who received the recommended Phase 2 dose (RP2D) of 8 mg Tilso/Ipi was calculated using the participant's best overall response (BOR). Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions
Interventions
- DRUG Ipilimumab
- DRUG IMO-2125
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-05 |
| Phase | Phase 2 |
What the finished NCT02644967 record still lists
NCT02644967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT02644967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02644967 about?
NCT02644967 is a clinical study titled "A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma". 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 i...
What is the current status of trial NCT02644967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2015-12. Estimated completion is 2021-05.
What interventions are being tested in trial NCT02644967?
The interventions under investigation include: Ipilimumab (DRUG), IMO-2125 (DRUG).
Who is sponsoring clinical trial NCT02644967?
This trial is sponsored by Idera Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02644967's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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