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Clinical Trials

Johns Hopkins Kimmel Cancer Center Melanoma Researchers

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 III

J1321: COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection.

This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the treatment of melanoma after removal by surgery. Patients with BRAF V600E/K mutation-positive cutaneous melanoma that has been completely removed by surgery but who are at high-risk for recurrence [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] may be eligible. Subjects will be randomized to receive either dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) combination therapy or two placebos for 12 months. Read more

 

Stage IV (metastatic) or unresectable Stage III

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.

 

J1264 - A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors.

The purpose of this study is to find the highest dose of the investigational drug MEDI4736 which can be given safely in patients with advanced melanoma and other cancers that is no longer responding to treatment. MEDI4736 is an antibody designed to boost the body’s immune system by targeting a protein on tumor cells called PD-L1.PD-L1 suppresses immune responses against cancer, so blocking PD-L1 with MEDI4736 may enhance anti-tumor immunity thereby controlling tumor growth.The drug will be given intravenously (by vein). The study does not allow patient who have already received any anti‐PD‐1 or anti‐PD‐L1 antibody. Patients who have been treated with anti-CTLA-4 (ipilimumab, Yervoy, tremelimumab) are eligible as long as they did not have severe side effects as a result of that therapy. 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.

 

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