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NCT02425306 · ClinicalTrials.gov registry record · Phase 1

Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

A Phase 1 study, sponsored by Craig L Slingluff, Jr.

Terminated
Registry status
Phase 1
Development phase
48
Enrollment target

NCT02425306: Clinical Trial Phase 1 study, sponsored by Craig L Slingluff, Jr.

NCT02425306 is a Phase 1 study that was terminated before completion, run by Craig L Slingluff, Jr. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02425306, a Phase 1 study, was terminated before completion, sponsored by Craig L Slingluff, Jr.

TERMINATED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study Summary

This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.

Primary Outcome

Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Montanide ISA-51
  • BIOLOGICAL 6MHP
  • DRUG polyICLC

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2015-05-12
Est. Completion 2018-01-08
Phase Phase 1
Craig L Slingluff, Jr

23 total trials

Why NCT02425306 stopped before completion

NCT02425306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT02425306 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02425306 about?

NCT02425306 is a clinical study titled "Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma". This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effe...

What is the current status of trial NCT02425306?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2015-05-12. Estimated completion is 2018-01-08.

What interventions are being tested in trial NCT02425306?

The interventions under investigation include: Cyclophosphamide (DRUG), Montanide ISA-51 (DRUG), 6MHP (BIOLOGICAL), polyICLC (DRUG).

Who is sponsoring clinical trial NCT02425306?

This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02425306's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 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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Source: ClinicalTrials.gov NCT02425306, the US trial registry maintained by the National Library of Medicine. NCT02425306 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.