Home Forums Melanoma Diagnosis: Stage IV New Trials Announced from N. California Melanoma Center

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    Catherine Poole
    Keymaster

    We are pleased to announce two new trials of therapy for patients with unresectable metastatic melanoma. These trials are now open for enrollment.

    First-Line: Randomized trial of Abraxane and Avastin vs ipilimumab

    Randomized Phase II Study of AB (nab-paclitaxel [Abraxane], Bevacizumab) versus Ipilimumab for 1st Line Therapy of Unresectable Stage IV Metastatic Malignant Melanoma (BRAF V600E Negative) (NCT02158520)

    Key Inclusion Criteria:

    • Unresectable Stage IV melanoma

    • No prior systemic therapy for metastatic melanoma

    • BRAF mutation not present

    Key Exclusion Criteria:

    • Brain metastasis

    Abraxane and Avastin will be provided without charge. The primary endpoint of the trial is progression-free survival. Patients will be randomized to receive Abraxane and Avastin or ipilimumab. At the time of disease progression, patients who meet eligibility criteria and are willing will receive the treatment being given in the other arm (crossover study design).

    Patients who have failed all therapies: Antibody-Drug Conjugate

    A Phase II Study of Glembatumumab Vedotin, an Anti-gpNMB Antibody-Drug Conjugate, in Patients with Advanced Melanoma (NCT02302339)

    Key Inclusion Criteria:

    • Unresectable Stage III or IV melanoma

    • Prior treatments must include ipilimumab and, for patients with a BRAF mutation, at least one BRAF or MEK targeted therapy.

    Key Exclusion Criteria:

    • Patients with ocular melanoma

    • Active, untreated brain metastases, except for patients with ≤3 small asymptomatic lesions where treatment is not indicated.

    This is a Phase II trial for patients who have had disease progression on standard therapies. All patients will receive the study drug; there is no control arm. Glembatumumab vedotin combines a tumor-targeting monoclonal antibody with a potent cytotoxic microtubule inhibitor. Treatments will be given by intravenous infusion every 21 days until disease progression or intolerance. The primary endpoint of the study is to evaluate the anti-cancer activity of the study drub in advanced melanoma as measured by the objective response rate.

    CLICK HERE TO CONTACT US

    To refer patients, please contact the Northern California Melanoma Center at 415-750-5660, or contact me directly any time at 415-435-9861.

    Cordially,

    Lynn E. Spitler, MD

    Director, Northern California Melanoma Center

    About Us

    The mission of the Northern California Melanoma Center (NCMC) is to provide service for patients with melanoma and their doctors, and to offer patients innovative clinical trials for therapy of melanoma.

    The strength of the NCMC lies in the Consulting Panel of physicians representing the various specialties dealing with melanoma. Our physicians meet weekly to discuss optimal management for each patient with melanoma.

    Northern California Melanoma Center

    Saint Mary’s Medical Center, 6th Floor

    450 Stanyan Street, San Francisco, California 94117-1079

    Phone: 415.750.5660 | Fax: 415.750.4860

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