Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
NCT ID: NCT01673854
Last Updated: 2018-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2012-09-13
2015-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg
Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
Ipilimumab
Vemurafenib
Interventions
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Ipilimumab
Vemurafenib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologic diagnosis of malignant melanoma tested positive for the BRAF V600 mutation
* Previously untreated unresectable Stage III or Stage IV melanoma
* Complete set of brain/neck, chest, abdomen/pelvis axial radiographs taken within 28 days of first dose of study drug
* Measurable melanoma by physical or radiographic examination
* Brain metastases stable after radiation for at least 1 month and off corticosteroid therapy for ≥30 days prior to enrollment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate hematologic parameters and renal and hepatic function
Exclusion Criteria
* Active brain metastases with symptoms or requiring corticosteroid treatment
* Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies
* History of or current immunodeficiency disease, splenectomy, or splenic irradiation
* Prior anticancer therapy or investigational products \<4 weeks prior to enrollment
* Prior therapy with a BRAF or MEK inhibitor and prior investigational anticancer immunotherapies;
* Prior therapies with immunosuppressive agents within the past 2 years
* Concomitant therapy with any anticancer or potent immunosuppressive agent, surgery, radiotherapy, other investigational anticancer therapies, or chronic use of systemic corticosteroids
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Beverly Hills Cancer Center
Beverly Hills, California, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Mount Sinai School Of Medicine
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Dumc
Durham, North Carolina, United States
University Hospitals Of Cleveland
Cleveland, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Countries
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References
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Amin A, Lawson DH, Salama AK, Koon HB, Guthrie T Jr, Thomas SS, O'Day SJ, Shaheen MF, Zhang B, Francis S, Hodi FS. Phase II study of vemurafenib followed by ipilimumab in patients with previously untreated BRAF-mutated metastatic melanoma. J Immunother Cancer. 2016 Aug 16;4:44. doi: 10.1186/s40425-016-0148-7. eCollection 2016.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2012-002054-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-240
Identifier Type: -
Identifier Source: org_study_id
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