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NCT03999749 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma
A Phase 2 study of Melanoma, sponsored by NYU Langone Health.
- Active
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 4
- Study locations
NCT03999749: Active Phase 2 study of Melanoma, sponsored by NYU Langone Health.
NCT03999749 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 71 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03999749, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a Phase II, open-label, single arm study. The study will consist of an assessment of the safety and tolerability of tocilizumab administered concurrently at 4 mg/kg every 6 weeks for 5 doses in combination with ipilimumab and nivolumab for four induction doses to week 12, then maintenance nivolumab alone up to one year to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will inform the use of this 3-drug combination for further phase II and/or phase III clinical testing. The trial will include an assessment of the pharmacodynamic activity of tocilizumab administered in combination with ipilimumab and nivolumab.
Primary Outcome
Adverse events are graded according to the NCI CTCAE version 5.0. Immune-related adverse events (irAEs) are specific events occurring within 100 days of the last dose (which includes pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine abnormalities \[adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis\]), regardless of causality, for which patients received immunosuppressive medication for treatment of the
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Tocilizumab
Study Locations (4)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
California
- The Angeles Clinic - Los Angeles
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2019-06-11 |
| Est. Completion | 2030-04-07 |
| Phase | Phase 2 |
What the registry record for NCT03999749 still lists
NCT03999749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03999749 reports a single indexed study location in Massachusetts, California, New York.
Frequently Asked Questions
What is clinical trial NCT03999749 about?
NCT03999749 is a clinical study titled "A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma". This is a Phase II, open-label, single arm study. The study will consist of an assessment of the safety and tolerability of tocilizumab administered concurrently at 4 mg/kg every 6 weeks for 5 doses in combination with ipilimumab and nivolumab for four induction doses to week 12, then maintenance ni...
What is the current status of trial NCT03999749?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2019-06-11. Estimated completion is 2030-04-07.
What conditions does trial NCT03999749 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT03999749?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT03999749?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03999749 being conducted?
This trial has 4 study locations across California, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03999749's enrollment target sits among peer trials
71 135th of 266 higher than 131 of 266 other Melanoma trials
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