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Although significant progress has been made in the treatment of melanoma, many important clinical questions still need to be answered. We continue to explore the frontiers of discovery in the treatment of melanoma thanks in part to the many patients who willingly to participate in new treatment trials. Participation in a new treatment trial can be a rewarding option for the appropriate patient. Clinical trial availability changes frequently. If you are a melanoma patient at Johns Hopkins Kimmel Cancer, please ask your health team about clinical trial participation. If you are not a Johns Hopkins patient but would be interested in participating in a trial, please contact us at 410-955-8804.
Melanoma Clinical Trials Available at Johns Hopkins (Kimmel Cancer Center searchable database.)
Summary of Current Melanoma Trials
Clinical trials open to enrollment by stage of disease
Stage IV (metastatic) or unresectable Stage III
J1517-An Exploratory Study of the Immunological Effects of Vemurafenib and Cobimetinib, Administered Alone and in Combination, in Subjects with Advanced BRAF V600E/K Mutant Melanoma
In this study, patients with unresectable stage III or stage IV metastatic BRAF V600E or V600K mutant melanoma will receive vemurafenib (Zelboraf) and cobimetinib (MEK inhibitor) and undergo tumor biopsies to understand the effects of both drugs on immune responses to melanoma. Both drugs have been shown in previous studies to cause the regression of advanced metastatic melanoma. The results of this study may help us to design more effective combination treatment regimens for patients with advanced melanoma.
Participants may have received prior systemic anti-cancer treatments except for BRAF or MEK inhibitors. Prior adjuvant immune-based therapy (e.g., interferon, ipilimumab, vaccine) will also be allowed. Patients with a history of autoimmune disease or a condition requiring systemic corticosteroids or immunosuppressive medication may be excluded. Subjects with brain metastases are eligible if these have been treated and there is no MRI evidence of progression for at least 4 weeks after treatment is complete.
J1333: Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy®) in Patients with Metastatic Melanoma.
This study will evaluate treatment of metastatic melanoma patients with two drugs given one after the other (in sequence). The two drugs being studied are ipilimumab (also known as Yervoy) and High Dose Interleukin-2 (abbreviated as HD IL-2, also known as Proleukin). Both drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma, although the two drugs have not been studied in sequence. About 100 patients are expected to enroll in this study at approximately 25 research centers in the United States. Participation in this study may last approximately 6 to 8 months, or longer, until the treatments are completed. There are two groups in this study: In group 1, patients will receive four cycles of HD IL-2 followed by four doses of ipilimumab. In group 2, you will receive four doses of ipilimumab followed by four cycles of HD IL-2. Patients are chosen by chance to one of two treatment groups. Both groups receive the same drugs but in a different sequence.In order to participate in this study, you must also be willing to participate in a second study, called PROCLAIM (see below). The second study is a Registry, or observational, study, which means the study staff follows your progress for 2 to 5 years after your involvement in the first study ends. Read more.
J1388: PROCLAIM REGISTRY PROTOCOL 10PLK13: Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy.
The PROCLAIM Registry is a US-based, multicenter study designed to establish an observational database of real-world clinical data on high dose IL-2 when used to treat patients with kidney cancer, melanoma or other cancers. The Registry will not suggest changes in the treatment or management of the patients enrolled in the Registry; physicians will continue to manage and treat patients according to standard of care and their own judgment. The database may be used to report and query patient care patterns, clinical outcomes and trends from IL-2 therapy. Read more.
J1282: - A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors.
This phase I study tests BMS-986015 (Anti-KIR) and BMS-936558 (Anti-PD-1) in patients with advanced solid tumors, including melanoma. BMS-986015 (Anti-KIR) and BMS-936558 (nivolumab, Anti-PD-1) are antibodies that help to activate the immune system. Although little is known about anti-KIR, a recent trial of nivolumab (anti-PD-1) given to 107 patients with advanced melanoma demonstrated that tumors shrank in about one-third of patients. Because these drugs have immune stimulatory properties, patients with autoimmune diseases are not eligible.Prior therapy with immune cell modulating antibodies such as anti-KIR, anti-PD-1, anti-PD-L1, anti-CD137 and anti-OX40 are not allowed. However, prior anti-CTLA4 therapy (ipilimumab, Yervoy, tremelimumab) is allowed.The study drugs will be given as an intravenous (IV) infusion. The BMS-936558 infusion will be given every 14 days for a total of 4 infusions in each cycle. The BMS-986015 infusion will be given on the 1st day and the 15th day of each cycle.Up to 12 cycles may be given. Read more.
J1382 - A Pilot Study of Stereotactic Radiosurgery combined with Ipilimumab in Patients with Newly Diagnosed Melanoma Metastases in the Brain and Spine
This study is being done to look at the safety of using stereotactic radiosurgery (SRS) and ipilimumab together to treat melanoma that has spread to the brain or spine. Both ipilimumab and SRS are used separately for the treatment of advanced melanoma. We are testing these therapies together because there is laboratory evidence that suggests that the combination may be more powerful than either treatment by itself.Ipilimumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of melanoma that has spread throughout the body. It works by activating your immune system to fight off cancer. Stereotactic radiosurgery (SRS) is approved by the Food and Drug Administration (FDA) for the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without needing to cut or use stitches. Read more.
J13101 A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
This phase I study tests BMS-986016 (Anti-LAG-3) and BMS-936558 (Anti-PD-1) in patients with advanced solid tumors, including melanoma. BMS-986016 (Anti-LAG-3) and BMS-936558 (nivolumab, Anti-PD-1) are drugs that help to activate the immune system. A recent trial of nivolumab (anti-PD-1) given to 107 patients with advanced melanoma demonstrated that tumors shrank in about one-third of patients. Because these drugs have immune stimulatory properties, patients with autoimmune diseases are not eligible.The study drugs will be given as an intravenous (IV) infusion. This study will enroll patients into 3 different groups. The first group will receive anti-LAG-3 alone. Prior therapy with immune cell modulating antibodies such as anti-KIR, anti-PD-1, anti-PD-L1, anti-CD137, anti-CTLA4 (ipilimumab, Yervoy, tremelimumab) and anti-OX40 are not allowed.The second and third groups will receive BMS-986016 (Anti-LAG-3) and BMS-936558 (Anti-PD-1) together.These groups allow patients who have received anti-PD-1 or anti-PD-L1 as their most recent therapy and whose disease has continued to progress. Read more.
ECOG 2607: Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery.
This is a phase II multicenter study for patients with locally advanced or metastatic mucosal melanoma (arising in the mucous membranes, such as the nostrils, mouth, or rectum), acral melanoma (arising in the palms, soles or under the nails), or solar melanoma (arising in skin with long-term sun damage) that cannot be removed by surgery.The purpose of this study is to evaluate if dasatinib can cause tumor regression in patients with these specific types of melanoma.Dasatinib is an oral medication that blocks some of the molecules needed for tumor growth.Dasatinib has historically been used in patients with certain types of leukemia, but has shown some activity in patients with certain types of melanoma.On this trial, patients will receive dasatinib by mouth twice a day. Treatment may continue for as long as benefit is shown. After finishing treatment, patients will be evaluated periodically for up to 5 years. Eligible patients must be at least 18 years old, have measurable disease and be at least 4 weeks out from chemotherapy, biological therapy, or radiation therapy. Patients who have had previous imatinib or sunitinib are not eligible. Patients with melanomas arising in the eye (ocular) are not eligible.Prior radiotherapy to a measurable lesion is allowed provided there is radiographic evidence of progression of that lesion.Patients may have brain metastases provided they have completed radiotherapy or surgical treatment, there is no evidence of progression for at least 8 weeks, and they do not require steroids.Tumor biopsy material must be available to evaluate genetic changes associated with susceptibility to dasatinib. Read more.
J12102: An Exploratory Study of the Biologic Effects of Nivolumab and Ipilimumab Monotherapy and Nivolumab in Combination with Ipilimumab Treatment in Subjects with Advanced Melanoma
This phase I study tests nivolumab (BMS-936558, Anti-PD-1) and ipilimumab (Yervoy) in patients with advanced melanoma who have tumors that can be biopsied. Nivolumab and ipilimumab are drugs that help to activate the immune system. A recent trial of both medications given together to 53 patients with advanced melanoma demonstrated that tumors shrank in about 40% of patients. Because these drugs have immune stimulatory properties, patients with autoimmune diseases are not eligible. The study drugs will be given as intravenous (IV) infusions. Prior therapy with immune cell modulating antibodies such as anti-KIR, anti-PD-1, anti-PD-L1, anti-CD137 and anti-OX40 is not allowed. Prior therapy with anti-CTLA4 (ipilimumab, Yervoy, tremelimumab) may be allowed.
J1497: Expanded Access Program with Nivolumab (BMS-936558) in Combination with Ipilimumab (Yervoy) in Anti-CLTA-4 Treatment-Naïve Subjects with Unresectable or Metastatic Melanoma.
This expanded access program provides treatment with and assesses the safety and tolerability of the combination of nivolumab (anti-PD-1) and ipilimumab (Yervoy) for patients with unresectable or metastatic melanoma. Because these drugs have immune stimulatory properties, patients with autoimmune diseases are not eligible. The study drugs will be given as intravenous (IV) infusions. Prior therapy with anti-CTLA4 (ipilimumab, Yervoy, tremelimumab) is not allowed. Patients with ocular (eye) melanoma are excluded. Subjects with brain metastases are eligible if these have been treated and there is no MRI evidence of progression for at least 2 weeks after treatment is complete.
J14182 - A Phase II Study of MK-3475 in Patients with Advanced Merkel Cell Carcinoma (MCC).
This trial studies how well pembrolizumab (anti-PD-1) works in treating patients with Merkel cell carcinoma (MCC) that cannot be removed by surgery or has spread to other parts of the body. Patients must have metastatic MCC or regional MCC that has recurred after surgery and/or radiation therapy. Patients who have received prior systemic therapy for MCC are not eligible. Because this drug has immune stimulatory properties, patients with some autoimmune diseases are not eligible.