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    Skin Cancer Clinical Trials

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    Further protocol information can be found on the links below at ClinicalTrials.gov


    Adjuvant  |  Neo-Adjuvant  |  Metastatic


    Active Trials

    Adjuvant

    Title: Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK- 3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group
    Description: This study will assess whether post-resection adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma [Stage IIIA (> 1 mm metastasis), IIIB and IIIC]
    Investigator: Kevin Kim, MD
    Eligibility: Subjects, 18 y/o and older, with completely resected Stage III melanoma. No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible)
    Status: Active and open to enrollment
    Contact: Ron Frianeza, 415-600-3027, Email: FrianeR@cpmcri.org about Study Merck MK3574-054

    Title: A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients With High Risk Resected Melanoma
    Description: This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B works compared with pembrolizumab in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread
    Investigator: NCI - National Cancer Institute
    Eligibility: Subjects, 18 y/o and older, who have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study; patients must be classified as stage IIIA (N2a), IIIB, IIIC, or stage IV melanoma; patients with melanoma of mucosal or other non-cutaneous origin are eligible; patients with melanoma of ocular origin are not eligible; patients with a history of brain metastases are ineligible.
    Status: Please contact site for study status
    Contact: Ron Frianeza, 415-600-3027, Email: FrianeR@cpmcri.org about Study SWOG S1404

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    Neo-Adjuvant

    Title: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma
    Description: This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma
    Investigator: Kevin Kim, MD
    Eligibility: Subjects, 18 y/o and older with a histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection
    Status: Active and open to enrollment
    Contact: Ron Frianeza, 415-600-3027, Email: FrianeR@cpmcri.org about Study TVEC 20110266

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    Metastatic

    Title: A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
    Description: This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer
    Investigator: Kevin Kim, MD
    Eligibility: Subjects, 18 to 80 years old, with locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden which may or may not be measurable. Tumor histology must be consistent with melanoma tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR.
    Status: Active and open to enrollment
    Contact: Ron Frianeza, 415-600-3027, Email:FrianeR@cpmcri.org about Study Immune Design LV305

    Title: Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV Melanoma
    Description: This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery
    Investigator: NCI - National Cancer Institute
    Eligibility: Subjects, 18 y/o and older, with unresectable stage III or stage IV melanoma; and must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
    Status: Coming Soon
    Contact: Ron Frianeza, 415-600-3027, Email:FrianeR@cpmcri.org about Study EA 6141

    Title: A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
    Description: Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors have disappeared, disease progression per modified Immune-Related Response Criteria (irRC), or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment. In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of pembrolizumab or end of treatment due to disappearance of injectable lesions, complete response, disease progression per irRC-RECIST or intolerance of study treatment.
    Investigator: Kevin Kim, MD
    Eligibility: Subjects, 18 to 95 years old, with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery is not recommended. Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.
    Status: Coming soon
    Contact: Ron Frianeza, 415-600-3027, Email:FrianeR@cpmcri.org about Study Amgen TVEC 20110265

    Title: A Phase 1 Safety Pilot/Phase II, Open-label Study of Varlilumab (CDX-1127) in Combination With Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or Stage IV Melanoma
    Description: This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining a) varlilumab and ipilimumab and b) varlilumab, ipilimumab, CDX-1401 and poly-ICLC.
    Investigator: Kevin Kim, MD
    Eligibility: Subjects, 18 y/o and older, with histologic diagnosis of melanoma, unresectable Stage III or IV disease and documented progressive disease based on radiographic, clinical or pathologic assessment.
    Status: Coming soon
    Contact: Ron Frianeza, 415-600-3027, Email:FrianeR@cpmcri.org about Study Celldex CDX1127-03

    Title: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma
    Description: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
    Investigator: NCI - National Cancer Institute
    Eligibility: MALE and FEMALE subjects, 18 y/o and older, with histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive. Patients must have BRAFV600E or BRAFV600K mutations. May have had prior systemic therapy in the adjuvant setting; patients may not have had any prior ipilimumab or BRAF inhibitors in the adjuvant setting.
    Status: Please contact site for study status.
    Contact: Ron Frianeza, 415-600-3027, Email:FrianeR@cpmcri.org about Study EA6134

    Title: A Phase Ib/II, Multicenter, Open Label, Study of LEE011 in Combination With MEK162 in Adult Patients With NRAS Mutant Melanoma
    Description: A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma
    Eligibility: Subjects, 18 y/o and older. Patients enrolled into phase Ib may be enrolled with evaluable disease only. Patients enrolled into the phase II expansion must have at least one measurable lesion as defined by RECIST 1.1 criteria for solid tumors
    Investigator: Kevin Kim, MD
    Status: Coming soon
    Contact: Ron Frianeza, 415-600-3027, Email: FrianeR@cpmcri.org about Study Array CMEK162X2114

    Title: Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination With Dabrafenib and Trametinib in Patients With BRAF Mutant Cancer
    Description: This phase I/II trial studies the side effects and the best dose of Akt inhibitor GSK2141795 (GSK2141795) when given together with dabrafenib and trametinib and to see how well they work in treating patients with stage IIIC-IV cancer
    Investigator: NCI - National Cancer Institute
    Eligibility: Subjects, 18 y/o and older who have BRAF^V600 mutant metastatic cancer irrespective of the histology or prior therapy
    Status: Active and open to enrollment
    Contact: Laurel Brechtel, 415-600-1654, Email: BrechtLA@cpmcri.org about Study SWOG S1221

    Title: A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects With Melanoma Metastatic to the Brain Treated With Nivolumab in Combination With Ipilimumab Followed by Nivolumab Monotherapy
    Description: This is an open-label, multi-site Phase 2 study of Nivolumab combined with Ipilimumab followed by Nivolumab monotherapy for the treatment of subjects with Melanoma metastatic to the brain
    Investigator: Kevin Kim, MD
    Eligibility: Subjects, 18 y/o and older who have histologically confirmed malignant melanoma with measurable metastases in both brain and extracranial compartments
    Status: Active and open to enrollment
    Contact: Laurel Brechtel, 415-600-1654, Email: BrechtLA@cpmcri.org about Study BMS CA209-204

    • updated May 2016

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