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NCT04091750 · ClinicalTrials.gov registry record · Phase 2
Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma
A Phase 2 study of Melanoma, sponsored by Georgetown University.
- Active
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 3
- Study locations
NCT04091750 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by Georgetown University. The registered enrollment target is 14 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04091750, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by Georgetown University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 3
- Study locations
Study Summary
In this phase II advanced melanoma study, all patients will receive treatment with nivolumab/ipilimumab plus cabozantinib for a 12 week induction period followed by nivolumab plus cabozantinib maintanence to complete up to 2 years of therapy unless disease progression, dose limiting toxicity, provider/patient decision or patient withdrawal of consent occurs. The primary endpoint is the one year PFS rate. Patients will have staging scans at baseline and every 12 weeks during the first 2 years on study. Safety evaluations including labs, EKG and history and physical will occur at each visit. Baseline tumor sample is required and on treatment biopsy will be optional of superficial tumor in the skin, subcutaneous tissue or lymph node that is palpable.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Cabozantinib
Study Locations (3)
District of Columbia
- Lombardi Comprehensive Cancer Center - Washington D.C.
Maryland
- Medstar Franklin Square Medical Center, Harry and Jeanette Weinberg Cancer Institute - Baltimore
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-03-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04091750
The ClinicalTrials.gov registry entry for NCT04091750 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
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.
NCT04091750 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, Maryland, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04091750 about?
NCT04091750 is a clinical study titled "Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma". In this phase II advanced melanoma study, all patients will receive treatment with nivolumab/ipilimumab plus cabozantinib for a 12 week induction period followed by nivolumab plus cabozantinib maintanence to complete up to 2 years of therapy unless disease progression, dose limiting toxicity, provid...
What is the current status of trial NCT04091750?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-03-02. Estimated completion is 2026-12.
What conditions does trial NCT04091750 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04091750?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT04091750?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04091750 being conducted?
This trial has 3 study locations across District of Columbia, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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