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NCT03929029 · ClinicalTrials.gov registry record · Phase 1
Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
A Phase 1 study of Cutaneous Melanoma, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03929029: Active Phase 1 study of Cutaneous Melanoma, sponsored by Dana-Farber Cancer Institute.
NCT03929029 is a Phase 1 study of Cutaneous Melanoma that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 11 participants, below the 367-participant average among 30 other Cutaneous Melanoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03929029, a Phase 1 study of Cutaneous Melanoma, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is investigating a new type of personalized neoantigen vaccine, NeoVax, plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for cutaneous melanoma. The drugs involved in this study are: * Personalized Neoantigen Vaccine * Poly-ICLC (Hiltonol®) * Montanide® * Ipilimumab (Yervoy™) * Nivolumab (Opdivo®)
Primary Outcome
DLT (Protocol Section 5.5) definition: 1. Grade 3 or 4 toxicity that is definitely, probably, or possibly related to administration of vaccine, excluding transient (≤ 72 hours) flu-like symptoms; grade 3 nausea, vomiting, diarrhea, or constipation that returns to grade 2 (or lower) within 48 hours; any grade 3 rash that resolves to grade 2 or lower within 14 days; any grade 3 endocrine abnormality that is corrected with hormonal therapy within 4 weeks. 2. Grade 3 or 4 abnormal laboratory value
Conditions Studied
Interventions
- DRUG Ipilimumab
- DRUG Nivolumab (480 mg infusion)
- BIOLOGICAL NeoVax plus Montanide
Study Locations (1)
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 1 |
What the registry record for NCT03929029 still lists
NCT03929029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 367-participant average among 30 other Cutaneous Melanoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Cutaneous Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Ipilimumab is the first listed.
NCT03929029 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03929029 about?
NCT03929029 is a clinical study titled "Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma". This research study is investigating a new type of personalized neoantigen vaccine, NeoVax, plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for cutaneous melanoma. The drugs involved in this study are: * Personalized Neoantigen Vaccine * Pol...
What is the current status of trial NCT03929029?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-11-11. Estimated completion is 2028-09-30.
What conditions does trial NCT03929029 study?
This clinical trial studies the following conditions: Cutaneous Melanoma.
What interventions are being tested in trial NCT03929029?
The interventions under investigation include: Ipilimumab (DRUG), Nivolumab (480 mg infusion) (DRUG), NeoVax plus Montanide (BIOLOGICAL).
Who is sponsoring clinical trial NCT03929029?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03929029 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03929029's enrollment target sits among peer trials
11 30th of 30 higher than 1 of 30 other Cutaneous Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous Melanoma 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.
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