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NCT01437605 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01437605: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01437605 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437605, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The overall purpose of this research study is to find a better way to treat melanoma. The goals of this study are: 1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC 2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with or without the Poly IC:LC 3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC 4. To measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC.
Primary Outcome
Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC
Interventions
- DRUG MAGE-A3 ASCI injections without Poly IC:LC
- DRUG MAGE-A3 ASCI injections with Poly IC:LC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-10-11 |
| Est. Completion | 2018-07-18 |
| Phase | Phase 2 |
Why NCT01437605 stopped before completion
NCT01437605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which MAGE-A3 ASCI injections without Poly IC:LC is the first listed.
NCT01437605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01437605 about?
NCT01437605 is a clinical study titled "Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC". The overall purpose of this research study is to find a better way to treat melanoma. The goals of this study are: 1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC 2. To see how well the pat...
What is the current status of trial NCT01437605?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2011-10-11. Estimated completion is 2018-07-18.
What interventions are being tested in trial NCT01437605?
The interventions under investigation include: MAGE-A3 ASCI injections without Poly IC:LC (DRUG), MAGE-A3 ASCI injections with Poly IC:LC (DRUG).
Who is sponsoring clinical trial NCT01437605?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01437605's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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