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

Part of paid clinical trials in Duarte, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02320058
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 5, 2015
Status verified
Sep 2021
Primary completion
Sep 8, 2020
Completion
Sep 8, 2020

Study Design

Enrollment
119 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ipilimumab
    Induction Phase: Nivolumab + Ipilimumab infusion intravenously Maintenance Phase: Nivolumab infusion intravenously

Primary Outcome Measure

Intracranial Clinical Benefit Rate (CBR) [ Time Frame: Up to 66 months ]

Locations (36)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
UCLA Medical Hematology and OncologyLos AngelesCalifornia90095-
Stanford UniversityPalo AltoCalifornia94304-
The California Pacific Medical Research InstituteSan FranciscoCalifornia94115-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
University of Colorado - Cancer Center - PPDSAuroraColorado80045-
Georgetown University Medical CenterWashington D.C.District of Columbia20057-
Washington Cancer Inst at MedStar Washington Hospital CtrWashington D.C.District of Columbia20007-
Weinberg Cancer Institute At Franklin SquareWashington D.C.District of Columbia20007-
Mount Sinai Medical CenterMiami BeachFlorida33140-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
The Cleveland Clinic FoundationWestonFlorida33331-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-1013-
University of ChicagoChicagoIllinois60637-
Loyola University Medical CenterMaywoodIllinois60153-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dana Farber Cancer Institute.BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02215-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Karmanos Cancer InstituteDetroitMichigan48201-
Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone Medical CenterNew YorkNew York10016-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Case School of Medicine University Hospitals of ClevelandClevelandOhio44106-5055-
Lehigh Valley Health NetworkAllentownPennsylvania18105-
St Luke's Health NetworkEastonPennsylvania18045-
Abramson Cancer Center of The University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Vanderbilt University Medical CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-
University of Utah - Huntsman Cancer Institute - PPDSSalt Lake CityUtah84112-
Inova Melanoma and Skin Cancer CenterFairfaxVirginia55905-

Find similar trials in Duarte, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
City of Hope· Duarte, CAAngeles Clinic and Research Institute· Los Angeles, CAUCLA Medical Hematology and Oncology· Los Angeles, CAStanford University· Palo Alto, CAThe California Pacific Medical Research Institute· San Francisco, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CA

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