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    Association details:
    Biomarker:No biomarker
    Cancer:Melanoma
    Drug:Opdivo (nivolumab) (PD1 inhibitor) +
    Yervoy (ipilimumab) (CTLA4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    06/19/2015
    Excerpt:
    OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of...patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ESMO 2023
    Title:

    1084MO - Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial

    Published date:
    10/16/2023
    Excerpt:
    The 7-year results of the NIBIT-M2 study, with the longest follow-up available to date in melanoma pts with asymptomatic BM treated with I+N, continue to show persistent therapeutic efficacy.
    Trial ID:
    NIBIT-M2
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401

    Published date:
    06/12/2023
    Excerpt:
    Nivolumab plus ipilimumab followed by nivolumab monotherapy was tolerable in patients with advanced melanoma and poor prognostic characteristics.
    DOI:
    10.1200/JCO.22.02199
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    Bristol Myers Squibb Announces Update on CheckMate -915 Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo in Resected High-Risk Melanoma Patients

    Published date:
    10/02/2020
    Excerpt:
    NON-SUPPORTIVE EVIDENCE: PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results for the co-primary endpoint for CheckMate -915, a randomized Phase 3 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma. The addition of Yervoy to Opdivo in this trial did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population.