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

Completed · Phase 2

Conditions studied: Melanoma

In brief

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 facts

Study ID

NCT02320058

Run by

Bristol-Myers Squibb

People needed

119

Starts

2015-03-05

Expected to finish

2020-09-08

Last updated by the study team

2021-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Target Population
• Histologically confirmed malignant melanoma with measurable metastases in the brain. Both asymptomatic and symptomatic patients.
• 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.
• 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
• Must have tumor tissue available for biomarker analysis. Biopsy should be excisional, incisional, punch, or core needle
• 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.
• Allowable prior therapy:
• 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
• 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
• Steroids for physiological replacement are allowed.
• Cohort A (asymptomatic): ECOG performance status ≤1 Cohort B (symptomatic): ECOG performance status ≤2

You may not qualify if…

• Target Disease Exceptions
• History of known leptomeningeal involvement (lumbar puncture not required)
• 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)
• Brain lesions >3 lesions which were previously treated with SRT
• 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.
• Physical and Laboratory Test Findings
• Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
• 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
• Allergies and Adverse Drug Reaction
• a) History of allergy to study drug components b) History of severe hypersensitivity reaction to any monoclonal antibody
• Other Exclusion Criteria
• Prisoners or subjects who are involuntarily incarcerated
• 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

Where it is running

• City of Hope — Duarte, California, United States
• Angeles Clinic and Research Institute — Los Angeles, California, United States
• UCLA Medical Hematology and Oncology — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• The California Pacific Medical Research Institute — San Francisco, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University of Colorado - Cancer Center - PPDS — Aurora, Colorado, United States
• Washington Cancer Inst at MedStar Washington Hospital Ctr — Washington D.C., District of Columbia, United States
• Weinberg Cancer Institute At Franklin Square — Washington D.C., District of Columbia, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• The Cleveland Clinic Foundation — Weston, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Dana Farber Cancer Institute. — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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