Melanoma

Clinical Trials

Below is a list of Melanoma clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Phase 1 Study of ABT-888 in Combination with Temozolomide (TMZ, Temodar) in Patients with Non-Hematologic (Blood) Malignancies (Cancer) and Metastatic Melanoma (MM)
This study is being done to:
- Evaluate the safety and tolerability of ABT-888 in combination with TMZ in treating solid cancers and metastatic melanoma
- Find the highest safe dose of ABT-888 in combination with TMZ (administered at one of two standard doses)
- Learn how the body handles and responds to treatment with ABT-888 and TMZ

Patients are also being asked to take part in an optional portion of the study to identify genetic reasons why certain individuals may respond differently to treatment with ABT-888 and TMZ.
ABT-888 is a new investigational drug being developed by Abbott Laboratories (Abbott) that interferes with the activity of PARP. PARP is an enzyme (protein) that may help cancer cells overcome injury or damage caused by radiation and certain types of chemotherapy. ABT-888 is not yet approved for use in the United States or any other countries. The U.S. Food and Drug
Administration (FDA) has allowed the use of ABT-888 in clinical trials.

TMZ is a chemotherapy drug that is approved by the FDA for the treatment of some types of brain cancer, and in Australia for the treatment of metastatic melanoma. However, the combination of ABT-888 and TMZ is also considered investigational. This clinical trial is the first study of this drug combination in humans.
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A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as Second-Line Treatment in Patients with Unresectable or Metastatic Melanoma
This study is being done to find out if the study drug can help patients with this disease and to find out what effects (good and bad) the study drug has on the patient. The study drug, LY 573636 is investigational and not approved for use by the U.S. Food and Drug Administration (FDA).
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A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment with 2 mg Intralesional Allovectin-7 Compared to Dacarbazine (DTIC) or Temozolomide (TMZ, Temodar) in Patients with Recurrent Metastatic Melanoma
The purpose of this study is to evaluate how safe Allovectin-7 is, and how well Allovectin-7 works as a possible treatment for melanoma in comparison to the chemotherapies dacarbazine (DTIC) or temozolomide (TMZ). This study will take place at multiple sites across the country and will enroll approximately 375 patients with metastatic melanoma (cancer that has spread). The treatment patients receive will consist of the injection of Allovectin-7 directly into their tumor or either DTIC chemotherapy given through their veins or TMZ capsules taken by mouth.
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A Phase II Trial of Melanoma Peptide (protein) Vaccinations for Patients with Metastatic Melanoma.
This study is being done to:
- Find out what effects (good and bad) the melanoma peptide vaccines have on patients with melanoma. Melanoma peptide vaccines are solutions of short proteins similar to proteins found in melanoma tumor tissue. This vaccine is being tested to see if it can stimulate the immune system to react against these proteins and against cancer. These melanoma peptide vaccines are considered investigational anticancer treatments as they have not been approved by the Food and Drug Administration (FDA).
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AVF4096g, A Phase II Study Evaluating the Efficacy and Safety of Bevacizumab (Avastin) in Combination with Carboplatin and Paclitaxel (Taxol)Chemotherapy for the First-Line Treatment of Patients with Metastatic Melanoma
Patients are being asked to take part in this research study because they have metastatic melanoma. This study will look at using an investigational drug, bevacizumab, in combination with chemotherapy. The study will look at whether the addition of bevacizumab to a carboplatin and paclitaxel chemotherapy lengthens the time before the patient's melanoma worsens compared with only carboplatin and paclitaxel chemotherapy and to see if it is safe. Bevacizumab, Carboplatin and Paclitaxel are approved by the U.S. Food and Drug Administration (FDA) for the use in other types of cancers. However, their treatment for metastatic melanoma remains experimental.
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Evaluating Surgery Followed by Radiation Therapy for Patients with Desmoplastic Melanoma (N0275)
This study is being done to find out what effects (good and bad) radiation therapy has on a patient and desmoplastic melanoma.
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Study with Interferon Alfa-2b compared to Observation with Routine Tests for Patients with Melanoma (E1697)
This study is being done to learn the effects (good and bad) of the treatment with the drug interferon Alfa-2b compared to no treatment after surgery in patients with melanoma.
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Studying the Activity and Side Effects of Timed Delivery of Standard Chemotherapy in Patients with Stage IV Metastatic Melanoma.
This study is being done to:
- To study the activity and adverse events (side effects) of timed delivery of standard paclitaxel/carboplatin (PC) in patients with stage IV melanoma who have already received chemotherapy for their metastatic disease.
- To study the activity and adverse events of timed delivery of standard temozolomide (TMZ) (Temodar) chemotherapy in patients with stage IV melanoma who have already received chemotherapy for their metastatic disease.
- To study the activity and adverse events of timed delivery of standard paclitaxel/carboplatin (PC) in patients with stage IV melanoma who have not already received chemotherapy for their metastatic disease.
- To study the activity and adverse events of timed delivery of standard temozolomide (TMZ) (Temodar) chemotherapy in patients with stage IV melanoma who have not already received chemotherapy for their metastatic disease.
- For each of the four patient groups, to study the changes of Treg cells.
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The Use of a Heat Treatment and Vaccine for Patients with Stage 4 Melanoma
This study is being done to learn about the anti-tumor effectiveness of a heat shock vaccine in patients with stage 4 metastatic malignant melanoma.
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The Use of Peptide (protein) Vaccines in Combination with GM-CSF (a medication believed to boost the body's immune system), IL-2 (a drug used to treat some forms of cancer) and an Oil Droplet-like Agent Called Montanide ISA 51-VG in Treating Melanoma
This study is being done to:
- Determine what side effects the vaccines have on patients.
- Determine how the body's immune system reacts to GM-CSF (a medication believed to boost the body's immune system), when mixed with melanoma peptides (proteins) and an oil droplet like agent called montanide ISA 51-VG.
- Determine how the body's immune system responds to low doses of IL-2 (a drug used to treat some forms of cancer) therapy given after the peptide immunization shots in some (not all) of the treated patients.
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Transcutaneous (Topical) Peptide Immunization with NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
This study is being done to:
- Test the safety of the NY-ESO-1b/resiquimod vaccine
- See what effects (good and bad) the NY-ESO-1b/resiguimod vaccine has on a patient
- See if using the vaccine as a gel versus injection is more effective in stimulating the immune system

Both agents used in this study (NY-ESO-1b and resiquimod) have been approved by the U.S. Food and Drug Administration (FDA) for use in clinical trials. Neither has been approved for commercial use.
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