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NCT02978443 · ClinicalTrials.gov registry record · Phase 2
A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02978443: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT02978443 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02978443, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma Research Foundation Breakthrough Consortium Virtual Repository at each participating institution. At the end of participation, samples will be sent to Georgetown University-Lombardi Comprehensive Cancer Center for processing and storage. An optional pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled patients. Patients will receive nivolumab in combination with ipilimumab according to the standard FDA approved treatment regimen.
Primary Outcome
ORR, defined as complete response \[CR\] + partial response \[PR\] per RECIST 1.1 criteria and to compare this response rate to the response rate of patients with "good" molecular predictive features
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-07-26 |
| Est. Completion | 2022-08-02 |
| Phase | Phase 2 |
Why NCT02978443 stopped before completion
NCT02978443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02978443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02978443 about?
NCT02978443 is a clinical study titled "A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab". Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for histopathology review and ...
What is the current status of trial NCT02978443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2017-07-26. Estimated completion is 2022-08-02.
What interventions are being tested in trial NCT02978443?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02978443?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02978443's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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