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NCT03021460 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
A Phase 1 study of Metastatic Melanoma and Unresectable Melanoma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03021460: Active Phase 1 study of Metastatic Melanoma and Unresectable Melanoma, sponsored by Mayo Clinic.
NCT03021460 is a Phase 1 study of Metastatic Melanoma and Unresectable Melanoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03021460, a Phase 1 study of Metastatic Melanoma and Unresectable Melanoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the best dose of ibrutinib when given together with pembrolizumab in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.
Primary Outcome
Will be defined as the highest dose level among those tested where at most one out of 6 patients develops a dose limiting toxicity prior to the start of their second course of treatment. The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Ibrutinib
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03021460 still lists
NCT03021460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (76% lower).
The record links to 7 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03021460 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03021460 about?
NCT03021460 is a clinical study titled "Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery". This phase I trial studies the best dose of ibrutinib when given together with pembrolizumab in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and ma...
What is the current status of trial NCT03021460?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-01-31. Estimated completion is 2026-12-31.
What conditions does trial NCT03021460 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Unresectable Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT03021460?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03021460?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03021460 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03021460's enrollment target sits among peer trials
20 64th of 91 higher than 24 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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