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NCT03816332 · ClinicalTrials.gov registry record · Phase 1
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
A Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 7
- Study locations
NCT03816332: Active Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT03816332 is a Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (86% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03816332, a Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tacrolimus, nivolumab, and ipilimumab may work better in treating kidney transplant recipients with cancer compared to chemotherapy, surgery, radiation therapy, or targeted therapies.
Primary Outcome
Percentage of kidney transplant recipients who experienced complete response (CR), partial response (PR) or stable disease (SD) without allograft loss.
Conditions Studied
Interventions
- DRUG Prednisone
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- DRUG Tacrolimus
Study Locations (7)
Florida
- Moffitt Cancer Center - McKinley Campus - Tampa
- Moffitt Cancer Center - Tampa
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-11-08 |
| Est. Completion | 2026-09-19 |
| Phase | Phase 1 |
What the registry record for NCT03816332 still lists
NCT03816332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Prednisone is the first listed.
NCT03816332 lists 7 locations in 5 states (Florida, Massachusetts, Illinois).
Frequently Asked Questions
What is clinical trial NCT03816332 about?
NCT03816332 is a clinical study titled "Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers". This phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some ...
What is the current status of trial NCT03816332?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-11-08. Estimated completion is 2026-09-19.
What conditions does trial NCT03816332 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Metastatic Skin Squamous Cell Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT03816332?
The interventions under investigation include: Prednisone (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT03816332?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03816332 being conducted?
This trial has 7 study locations across Florida, Illinois, Maryland, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03816332's enrollment target sits among peer trials
12 85th of 91 higher than 6 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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