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NCT03769155 · ClinicalTrials.gov registry record · Phase 1
VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma
A Phase 1 study of Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, sponsored by Emory University.
- Active
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03769155: Active Phase 1 study of Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, sponsored by Emory University.
NCT03769155 is a Phase 1 study of Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by Emory University. The registered enrollment target is 41 participants, below the 69-participant average among 6 other Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769155, a Phase 1 study of Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed by surgery. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
The two-sample t-test will be used to compare the change in CD8+ T cell infiltration after treatment between each experimental group (Cohort A, B, C, and D) and the control group (cohort E), respectively.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- PROCEDURE Surgery
- BIOLOGICAL Ipilimumab
- BIOLOGICAL VX15/2503
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-12-13 |
| Est. Completion | 2032-12-15 |
| Phase | Phase 1 |
What the registry record for NCT03769155 still lists
NCT03769155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 69-participant average among 6 other Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (41% lower).
The record links to 3 conditions, with Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT03769155 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03769155 about?
NCT03769155 is a clinical study titled "VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma". This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed by surgery. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab may interfere with the ability of t...
What is the current status of trial NCT03769155?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-12-13. Estimated completion is 2032-12-15.
What conditions does trial NCT03769155 study?
This clinical trial studies the following conditions: Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT03769155?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Surgery (PROCEDURE), Ipilimumab (BIOLOGICAL), VX15/2503 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03769155?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03769155 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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