Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02320058 · ClinicalTrials.gov registry record · Phase 2
An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself
A Phase 2 study of Melanoma, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT02320058: Completed Phase 2 study of Melanoma, sponsored by Bristol-Myers Squibb.
NCT02320058 is a Phase 2 study of Melanoma that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 119 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02320058, a Phase 2 study of Melanoma, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study of Nivolumab combined with Ipilimumab followed by Nivolumab by itself for the treatment of patients with Melanoma that has spread to the brain. Patients with histologically confirmed Malignant Melanoma and asymptomatic brain metastases are eligible for the study.
Primary Outcome
Intracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \>6 months, as determined by modified RECIST 1.1 criteria for index intracranial lesions based on investigator review.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Study Locations (20)
California
- City of Hope - Duarte
- Angeles Clinic and Research Institute - Los Angeles
- UCLA Medical Hematology and Oncology - Los Angeles
- Stanford University - Palo Alto
- The California Pacific Medical Research Institute - San Francisco
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
District of Columbia
- Washington Cancer Inst at MedStar Washington Hospital Ctr - Washington D.C.
- Weinberg Cancer Institute At Franklin Square - Washington D.C.
- Georgetown University Medical Center - Washington D.C.
Florida
- Mount Sinai Medical Center - Miami Beach
- H Lee Moffitt Cancer Center and Research Institute - Tampa
- The Cleveland Clinic Foundation - Weston
Massachusetts
- Dana Farber Cancer Institute. - Boston
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Illinois
- University of Chicago - Chicago
- Loyola University Medical Center - Maywood
Colorado
- University of Colorado - Cancer Center - PPDS - Aurora
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2015-03-05 |
| Est. Completion | 2020-09-08 |
| Phase | Phase 2 |
What the finished NCT02320058 record still lists
NCT02320058 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT02320058 names 20 study sites across 8 states, led by California, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT02320058 about?
NCT02320058 is a clinical study titled "An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself". This is a study of Nivolumab combined with Ipilimumab followed by Nivolumab by itself for the treatment of patients with Melanoma that has spread to the brain. Patients with histologically confirmed Malignant Melanoma and asymptomatic brain metastases are eligible for the study.
What is the current status of trial NCT02320058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2015-03-05. Estimated completion is 2020-09-08.
What conditions does trial NCT02320058 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT02320058?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT02320058?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02320058 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. 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 NCT02320058's enrollment target sits among peer trials
119 103rd of 266 higher than 164 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
- NCT04870762 · 119 participants · Phase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
- NCT05559853 · 119 participants
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
- NCT06564389 · 119 participants · Phase 1
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
- NCT06742801 · 119 participants · NA
Onyx™ Liquid Embolic IDE Clinical Study
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
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI