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NCT04967196 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04967196: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT04967196 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04967196, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This phase I trial identifies the best dose of ipilimumab that can be administered through the DoseConnect™ device followed by nivolumab in treating patients with stage III melanoma that cannot be removed by surgery (unresectable) or stage IV melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
MTD is defined as the dose level where at most 1 of the 6 patients treated at that dose level develops a dose-limited event (DLE) during the first cycle of treatment and neither a Grade 3 or worse adverse event (AE) attributable to either drug or device or a Grade 2 or worse AE lasting ≥1 week and attributable to device reported after the first cycle of treatment.
Interventions
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- PROCEDURE Lymph Node Assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 1 |
Why NCT04967196 stopped before completion
NCT04967196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04967196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04967196 about?
NCT04967196 is a clinical study titled "Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma". This phase I trial identifies the best dose of ipilimumab that can be administered through the DoseConnect™ device followed by nivolumab in treating patients with stage III melanoma that cannot be removed by surgery (unresectable) or stage IV melanoma that has spread to other places in the body (met...
What is the current status of trial NCT04967196?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-09-16. Estimated completion is 2024-04-17.
What interventions are being tested in trial NCT04967196?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Lymph Node Assessment (PROCEDURE).
Who is sponsoring clinical trial NCT04967196?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04967196's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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