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NCT04493203 · ClinicalTrials.gov registry record · Phase 2
Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma
A Phase 2 study, sponsored by Yana Najjar.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT04493203: Completed Phase 2 study, sponsored by Yana Najjar.
NCT04493203 is a Phase 2 study that has completed, run by Yana Najjar. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493203, a Phase 2 study, has completed, sponsored by Yana Najjar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.
Primary Outcome
Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Interventions
- DRUG Nivolumab
- DRUG Axitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2025-04-12 |
| Phase | Phase 2 |
What the finished NCT04493203 record still lists
NCT04493203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04493203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493203 about?
NCT04493203 is a clinical study titled "Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma". This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg ...
What is the current status of trial NCT04493203?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2020-12-18. Estimated completion is 2025-04-12.
What interventions are being tested in trial NCT04493203?
The interventions under investigation include: Nivolumab (DRUG), Axitinib (DRUG).
Who is sponsoring clinical trial NCT04493203?
This trial is sponsored by Yana Najjar, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04493203's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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