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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Target Population 1. Histologically confirmed malignant melanoma with measurable metastases in the brain. Both asymptomatic and symptomatic patients. 2. Cohort A (asymptomatic patients): At least 1 measurable brain metastasis ≥ 0.5 cm in and ≤ 3 cm in longest diameter that has not been previously irradiated. No clinical requirement for local intervention (surgery, radiosurgery, corticosteroid therapy) or other systemic therapy Cohort B (symptomatic patients): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligibile. Subjects must have at least 1 measurable brain metastasis ≥ 0.5 cm in and ≤ 3 cm in longest diameter that has not been previously irradiated. No immediate requirement (within 3 weeks prior to first treatment) for local intervention (surgery, radiosurgery, corticosteroid therapy). Steroid use is permitted as defined in the protocol. 3. Prior stereotactic radiotherapy (SRT) and prior excision of up to 3 melanoma brain metastases is permitted if there has been complete recovery, with no neurologic sequelae, and measurable lesions remain. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable. lesions or prior excision must have occurred ≥ 3 weeks before the start of dosing for this study 4. Must have tumor tissue available for biomarker analysis. Biopsy should be excisional, incisional, punch, or core needle 5. Cohort A (asymptomatic): Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy within 10 days prior to first treatment. Cohort B (symptomatic): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligible per Amendment 02. Subjects with neurologic signs and symptoms may be treated with a total daily dose of no more than 4 mg of dexamethasone that is stable or tapering for 10 days prior to first treatment. Subjects with neurologic signs and symptoms who are not being treated with steroids are eligible for Cohort B and should have no experience of seizure within 10 days prior to first treatment. 6. Allowable prior therapy: 1. Approved adjuvant therapies, which may include molecularly-targeted agents, IFN α, and ipilimumab. Patients who received ipilimumab as adjuvant therapy must have a 6 month washout before receiving any dosing on this study 2. For advanced disease, interleukin-2 at any dose and/or IFN-α (any formulation, no washout required); MEK and BRAF inhibitors: washout for at least 4 weeks prior to the start of dosing in this study 3. Steroids for physiological replacement are allowed. 7. Cohort A (asymptomatic): ECOG performance status ≤1 Cohort B (symptomatic): ECOG performance status ≤2

Exclusion Criteria:

2. Target Disease Exceptions 1. History of known leptomeningeal involvement (lumbar puncture not required) 2. Previous stereotactic or highly conformal radiotherapy within 3 weeks before the start of dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion(s) 3. Brain lesions >3 lesions which were previously treated with SRT 4. Brain lesion size > 3cm 3. Medical History and Concurrent Diseases a) History of whole brain irradiation b) Subjects with an active, known or suspected autoimmune disease c) Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled d) Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. For any prior invasive malignancy, at least 5 years must have elapsed since curative therapy and patients must have no residual sequelae of prior therapy e) Cohort A (asymptomatic): The use of corticosteroids is not allowed within 10 days prior to first treatment (based upon 5 times the expected half life of dexamethasone) except patients who are taking steroids for physiological replacement. If alternative corticosteroid therapy has been used, consultation with the sponsor Medical Monitor is required to determine the washout period prior to initiating study treatment Cohort B (symptomatic): Subjects with neurologic sign and symptoms related to brain metastases who are being treated with a total daily dose of higher than 4 mg dexamethasone or equivalent within 10 prior to the start of treatment with study drug are excluded. 4. Physical and Laboratory Test Findings 1. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection 2. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on ART—due to the unknown effects of HIV on the immune response to combined nivolumab plus ipilimumab or the unique toxicity spectrum of these drugs in patients with HIV 5. Allergies and Adverse Drug Reaction a) History of allergy to study drug components b) History of severe hypersensitivity reaction to any monoclonal antibody 6. Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria Other protocol defined inclusion/exclusion criteria could apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02320058
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Kim Margolin, Site 0040

626256467380572

Angeles Clinic and Research Institute, Los Angeles, California

Status

Recruiting

Address

Angeles Clinic and Research Institute

Los Angeles, California, 90025

Site Contact

Omid Hamid, Site 0006

310-231-2182

UCLA Medical Hematology and Oncology, Los Angeles, California

Status

Recruiting

Address

UCLA Medical Hematology and Oncology

Los Angeles, California, 90095

Site Contact

John Glaspy, Site 0037

310-794-3883

Stanford University, Palo Alto, California

Status

Recruiting

Address

Stanford University

Palo Alto, California, 94304

Site Contact

Reena Thomas, Site 0010

San Francisco, California

Status

Recruiting

Address

The California Pacific Medical Research Institute

San Francisco, California, 94115

Site Contact

Kevin Kim, Site 0028

415-600-3613

San Francisco, California

Status

Recruiting

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Site Contact

Alain Algazi, Site 0002

University of Colorado Cancer Center, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Cancer Center

Aurora, Colorado, 80045

Site Contact

Karl Lewis, Site 0022

Local Institution, New Haven, Connecticut

Status

Not yet recruiting

Address

Local Institution

New Haven, Connecticut, 06520

Site Contact

Site 0026

Washington, District of Columbia

Status

Recruiting

Address

Washington Cancer Inst at MedStar Washington Hospital Ctr

Washington, District of Columbia, 20010

Site Contact

Michael Atkins, Site 0036

Georgetown University Medical Center, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University Medical Center

Washington, District of Columbia, 20057

Site Contact

Michael Atkins, Site 0003

Mount Sinai Medical Center, Aventura, Florida

Status

Recruiting

Address

Mount Sinai Medical Center

Aventura, Florida, 33180

Site Contact

Jose Lutzky, Site 0017

Tampa, Florida

Status

Recruiting

Address

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Site Contact

Peter Forsyth, Site 0013

813-745-5283

Atlanta, Georgia

Status

Recruiting

Address

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322-1013

Site Contact

Ragini Kudchadkar, Site 0034

404-778-4520

Loyola University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Loyola University Medical Center

Chicago, Illinois, 60153

Site Contact

Joseph Clark, Site 0004

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Site Contact

Jason Luke, Site 0027

Baltimore, Maryland

Status

Recruiting

Address

Weinberg Cancer Institute At Franklin Square

Baltimore, Maryland, 21237

Site Contact

Michael Atkins, Site 0035

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

F Stephen Hodi, Site 0024

617-643-3754

Dana Faber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Faber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

F. Stephen Hodi, Site 0023

617-632-9293

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

F Stephen Hodi, Site 0007

617-632-4503

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Site Contact

Christopher Lao, Site 0020

Karmanos Cancer Institute, Detroit, Michigan

Status

Recruiting

Address

Karmanos Cancer Institute

Detroit, Michigan, 48201-2014

Site Contact

Amy Weise, Site 0016

313-576-9730

Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Recruiting

Address

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903-2681

Site Contact

Ann Silk, Site 0025

732-235-8780

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Igor Puzanov, Site 0042

NYU Langone Medical Center, New York, New York

Status

Recruiting

Address

NYU Langone Medical Center

New York, New York, 10016

Site Contact

Anna Pavlick, Site 0031

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Michael Postow, Site 0033

646-888-4497

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

Site Contact

Stergios Moschos, Site 0032

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

April Salama, Site 0030

919-686-1654

Cleveland, Ohio

Status

Recruiting

Address

Case School of Medicineuniversity Hospitals of Cleveland

Cleveland, Ohio, 44106-5055

Site Contact

Henry Koon, Site 0021

216-844-5393

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Manmeet Ahluwalia, Site 0001

Lehigh Valley Health Network, Allentown, Pennsylvania

Status

Recruiting

Address

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

Site Contact

Suresh Nair, Site 0018

610-402-0636

St Luke's Health Network, Easton, Pennsylvania

Status

Recruiting

Address

St Luke's Health Network

Easton, Pennsylvania, 18045

Site Contact

Sanjiv Agarwala, Site 0014

484-503-4153

Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Site Contact

Ahmad Tarhini, Site 0015

412-623-6130

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Kristin Ancell, Site 0012

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Hussein Tawbi, Site 0039

713-792-2923

Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah, 84112

Site Contact

Kenneth Grossmann, Site 0041

Inova Melanoma and Skin Cancer Center, Fairfax, Virginia

Status

Recruiting

Address

Inova Melanoma and Skin Cancer Center

Fairfax, Virginia, 55905

Site Contact

Sekwon Jang, Site 0008

703-970-6548

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