Melanoma Clinical Trials

California Pacific CURRENTS: The online journal of CPMC Research Institute

Adjuvant Therapy

 

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

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

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

Contacts

Laurel Brechtel, 415-600-1654, Email: BrechtLA@cpmcri.org about Study SWOG S1404

Metastatic Therapy

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

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

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

Active and open to enrollment

Contacts

Laurel Brechtel, 415-600-1654, Email: BrechtLA@cpmcri.org about Study SWOG S1404

Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes

Description: The aim of this study is to investigate whether the Sentinella camera improves intraoperative detection and removal of sentinel lymph nodes (SLNs) when used in conjunction with standard detection methods. Of primary interest is whether the Sentinella camera identifies additional tumor-positive SLNs that are missed using traditional imaging techniques. Other outcomes related to the standard of care use of the Sentinella camera may also be assessed.

Investigators

  • Stanley Leong, MD

Eligibility Requirements

All melanoma patients, 18 y/o and older, with a Breslow thickness >1mm, who are seen at CPMC for sentinel node biopsy will be eligible to participate in this study provided that they have given consent.

Status

Active and open to enrollment

Contacts

Anna von Bakonyi, LVN, 415-600-1107

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

Investigators

Eligibility Requirements

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

Contacts

Laurel Brechtel, 415-600-1654

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.

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

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.

Contacts

Laurel Brechtel, 415-600-1654, Email: BrechtLA@cpmcri.org about Study SWOG S1404

 
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

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

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

Contacts

Laurel Brechtel, 415-600-1654

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

Investigators

Eligibility Requirements

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

Contacts

Laurel Brechtel, 415-600-1654

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.

Investigators

Eligibility Requirements

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

Contacts

Ron Frianeza, 415-600-3027

Neo-Adjuvant Therapy

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

Investigators

Eligibility Requirements

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

Contacts

Ron Frianeza, 415-600-3027