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NCT03617328 · ClinicalTrials.gov registry record · Phase 1
Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma
A Phase 1 study, sponsored by Craig L Slingluff, Jr.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT03617328: Completed Phase 1 study, sponsored by Craig L Slingluff, Jr.
NCT03617328 is a Phase 1 study that has completed, run by Craig L Slingluff, Jr. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617328, a Phase 1 study, has completed, sponsored by Craig L Slingluff, Jr.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and tissue from a vaccine site.
Primary Outcome
Number of participants with dose-limiting toxicities based on CTCAE v5.0
Interventions
- DRUG Montanide ISA-51
- BIOLOGICAL 6MHP
- DRUG polyICLC
- DRUG CDX-1127
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-11-13 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 1 |
What the finished NCT03617328 record still lists
NCT03617328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Montanide ISA-51 is the first listed.
NCT03617328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617328 about?
NCT03617328 is a clinical study titled "Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma". This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. Th...
What is the current status of trial NCT03617328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2018-11-13. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT03617328?
The interventions under investigation include: Montanide ISA-51 (DRUG), 6MHP (BIOLOGICAL), polyICLC (DRUG), CDX-1127 (DRUG).
Who is sponsoring clinical trial NCT03617328?
This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03617328's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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