Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Melanoma, sponsored by Georgetown University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PFS rate for nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma using imRECIST.
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 |
What the registry record for NCT04091750 still lists
NCT04091750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (98% 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.
NCT04091750 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for 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 NCT04091750's enrollment target sits among peer trials
14 244th of 266 higher than 20 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
-
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
RECRUITING · Phase 2
-
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
RECRUITING · Phase 2
-
Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma
RECRUITING · Phase 2
-
A Study of IBI363 in Subjects with Advanced Solid Malignancies
RECRUITING · Phase 2
-
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
RECRUITING · Phase 2
-
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy