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NCT03445533 · ClinicalTrials.gov registry record · Phase 3
A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
A Phase 3 study, sponsored by Idera Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
NCT03445533: Clinical Trial Phase 3 study, sponsored by Idera Pharmaceuticals.
NCT03445533 is a Phase 3 study that was terminated before completion, run by Idera Pharmaceuticals. The registered enrollment target is 481 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03445533, a Phase 3 study, was terminated before completion, sponsored by Idera Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
Study Summary
A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
Primary Outcome
The ORR for evaluable participants was calculated using the participant's best overall response (BOR). Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - \>=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum o
Interventions
- DRUG Ipilimumab
- DRUG Tilsotolimod with Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 3 |
Why NCT03445533 stopped before completion
NCT03445533 is an interventional study that assigns participants to a tested intervention. The registered 481 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT03445533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03445533 about?
NCT03445533 is a clinical study titled "A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma". A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma
What is the current status of trial NCT03445533?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2018-05-30. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT03445533?
The interventions under investigation include: Ipilimumab (DRUG), Tilsotolimod with Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT03445533?
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 NCT03445533's enrollment target sits among peer trials
481 792nd of 2000 higher than 1,209 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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