Melanoma Clinical Trials

For more information on these trials, call AskMDAnderson toll-free at 1-877-632-6789.

Neoadjuvant

Neoadjuvant and Adjuvant Dabrafenib and Trametinib Compared to Upfront Surgery in Patients with Clinical Stage III or Oligometastatic Stage IV Melanoma (Combi-Neo) (2014-0409) (NCT02231775)
Principal Investigator: Jennifer Wargo, M.D.
Co-Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to compare receiving the combination of dabrafenib and trametinib before surgery to having surgery alone in patients with melanoma. The safety of the study drug combination will also be studied.

Neoadjuvant and Adjuvant Checkpoint Blockade in Patients with Clinical Stage III or Oligometastatic Stage IV Melanoma (2015-0041)   (NCT02519322)
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to learn if giving nivolumab alone or in combination with ipilimumab before and after surgery can help to control metastatic melanoma. The safety of these drugs will also be studied.

Adjuvant

A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma (S1404)  (NCT02506153) 
Principal Investigator: Sapna P. Patel, M.D.
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. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B is more effective than pembrolizumab in treating patients with melanoma.

Chemotherapy-Naive Patients (no previous chemotherapy)

Phase II Study of Abraxane Plus Ipilimumab in Patients with Metastatic Melanoma (2011-1157) (NCT01827111)
Principal Investigator: Adi Diab, M.D.
The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. ABI-007 is designed to stop cancer cells from making new DNA (the genetic material of cells.) This may stop the cancer cells from dividing into new cells.

A Phase Ib, Open-label Study of the Safety and Pharmacology of MPDL3280A Administered in Combination with Vemurafenib in Patients with Previously Untreated BRAFV600-Mutation Positive Metastatic Melanoma (2012-0588) (NCT01656642)
Principal Investigator: Patrick Hwu, M.D.
The goal of this clinical research study is to find the highest tolerable dose of MPDL3280A that can be given in combination with vemurafenib (Zelboraf) to patients with locally advanced or metastatic melanoma that has a BRAF mutation. The safety of the drug combination will also be studied. MPDL3280A is designed to help the immune system recognize the tumors and may help stop their growth. Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer cells to grow and multiply. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.

Patients with Previous Chemotherapy

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 (2015-0696) (NCT02320058)
Principal Investigator: Hussein Tawbi, M.D., Ph.D.
The goal of this clinical research study is to learn about how treatment with the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) may affect the disease that has spread to the brain. Researchers will also test if the drugs can control the disease outside the brain and the safety of the drugs.

A Phase I/II Study to Assess the Safety and Efficacy of Intratumoral IMO-2125 in Combination with Ipilimumab in Patients with Metastatic Melanoma (2015-0530) (NCT02644967)
Principal Investigator: Adi Diab, M.D.
The purpose of this clinical research study is to find the highest tolerated dose of the study drug IMO-2125 that can be given in combination with ipilimumab to patients with metastatic melanoma. Researchers also want to learn if the study drug combination can help to control the disease. The safety of the drug combination will also be studied.  

A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 in Subjects with Locally Advanced or Metastatic Solid Tumor Malignancies (2015-0573)  
Principal Investigator: Adi Diab, M.D.
The goal of this clinical research study is to find the highest tolerable dose of the study drug NKTR-214 that can be given to patients with advanced or recurrent solid tumors. Researchers also want to learn if NKTR-214 can help to control the disease. This is the first study using NKTR-214 in humans.

Phase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma and Other Solid Tumors (2014-0020) (NCT01989585)
Principal Investigator: Michael A. Davies, M.D., Ph.D.
The purpose of the second part of this study (Phase II) is to compare the good and bad effects of navitoclax in combination with dabrafenib and trametinib to using the usual approach of dabrafenib and trametinib in patients with BRAF-mutant melanoma. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. 

A Phase I, Open-Label, Dose Escalation Study of PF-04518600 in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC), Melanoma, Clear Cell Renal Cell Carcinoma (RCC) or Squamous Cell Head and Neck Cancer (SCCHN) (2014-0996) (NCT02315066)
Principal Investigator: Adi Diab, M.D.
The goal of this clinical research study is to find the highest tolerable dose of the study drug PF-04518600 that can be given to patients with advanced cancer. Researchers also want to learn more about the effects of the study drug. The safety of the drug will also be studied.

A Phase II Open-Label, Two-Arm Study of the MEK Inhibitor, Trametinib, to Investigate the Safety and Anti-Cancer Activity in Subjects with Melanoma with BRAF non-V600 Mutations (2014-0766) (NCT02296112)
Principal Investigator: Michael Davies, M.D., Ph.D.
Some types of melanoma have a kind of BRAF mutation called a BRAF V600 mutation. A drug called trametinib is FDA-approved and commercially available to treat these types of melanoma. The goal of this clinical research study is to learn if trametinib can help to control melanoma with a BRAF mutation that is not a BRAF V600 mutation. The safety of this drug will also be studied.

Phase II Study of MK-3475 in Conjunction with Lymphodepletion, TIL, and High or Low Dose IL-2 in Patients with Metastatic Melanoma (2014-0922) (NCT02500576)
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to learn if pembrolizumab, an infusion of T-cells, chemotherapy (cyclophosphamide and fludarabine), and either high- or low-dose interleukin-2 (IL-2) can help to control metastatic melanoma. The safety of this drug combination will also be studied.  T-cells are white blood cells in your body that are important to the immune system. The T-cells used in this study will be collected and grown in a separate study (MD Anderson Protocol 2004-0069.)

An Open-Label, Multicentre, Corollary Study of Pre-Operative Therapy with Dabrafenib and the Combination of Dabrafenib with Trametinib in Subjects with BRAF Mutation-Positive Metastatic Melanoma to the Brain (2012-0208) (NCT01978236)
Principal Investigator: Michael Davies, M.D., Ph.D.
The goal of this clinical research study is to learn how much of the study drugs dabrafenib and trametinib get into the brain tumor, any tumor(s) outside the brain, and the blood stream. This will be tested in patients who have melanoma that has spread to the brain. Researchers also want to learn if and how long dabrafenib and trametinib may be able to help control the disease. Lab research will be done that may benefit future patients.

An Open-Label, Multicenter, Dose-Escalation, Phase 1b/2 Study of the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RTA 408 in Combination with Ipilimumab in the Treatment of Patients with Unresectable or Metastatic Melanoma (2014-0613) (NCT02259231)
Principal Investigator: Sapna Patel, M.D.
The goal of Part 1 of this clinical research study is to find the highest tolerated dose of RTA 408 that can be given with ipilimumab to patients with unresectable or metastatic melanoma. The safety of this drug combination will also be studied. The goal of Part 2 of this study is to learn if giving RTA 408 with ipilimumab can help to control unresectable or metastatic melanoma.

Lymphodepletion Plus Adoptive Cell Transfer with TGF-beta Resistant (DNRII) and NGFR Transduced T-Cells Followed by High-Dose Interleukin-2 in Patients with Metastatic Melanoma (2012-0758) (NCT01955460)
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to find the highest tolerable dose of T-cells injected with the genes TGFb-DNR and NGFR that can be given in combination with chemotherapy (cyclophosphamide and fludarabine) and aldesleukin to patients with metastatic melanoma.This study involves gene therapy. T-cells are types of white blood cells that help your body fight infections. They may recognize and kill melanoma cells. Researchers want to grow your T-cells in a laboratory, inject them with TGFb-DNR and NGFR genes which may help them recognize tumor cells, and then give them back to you by vein. This may help to control melanoma. Cyclophosphamide is designed to block cancer cells from dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die. Aldesleukin is designed to block the activity of cells that may decrease the immune system's ability to fight cancer.

A Phase I/II Study of Lymphodepletion Plus Adoptive Cell Transfer with T-Cells Transduced with CXCR2 and NGFR Followed by High-Dose Interleukin-2 in Patients with Metastatic Melanoma (2009-0471) (NCT01740557)
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to learn the side effects of T-cells injected with CXCR2 and NGFR when given in combination with chemotherapy (cyclophosphamide and fludarabine) and aldesleukin to patients with metastatic melanoma in an attempt to allow them to better localize the tumor. The safety of this combination will also be studied.

BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that Has Metastasized to the Brain (2013-1020) (NCT02039947)
Principal Investigator: Michael Davies, M.D., Ph.D.
The goal of this clinical research study is to learn if the combination of dabrafenib and trametinib can help to control BRAF V600 positive melanoma that has spread to the brain. The safety of the study drugs will also be studied.

T-Cells +/- Dendritic Cells (2004-0069) Phase II (NCT00338377)
Principal Investigator: Patrick Hwu, M.D.
In this study, T-cells capable of recognizing and killing melanoma will be isolated from tumor biopsies and expanded in the laboratory.  The T-cells will then be reinfused into the patients with or without dendritic cells, which are immune cells capable of potently activating T-cells.  This study is for patients with a good performance status, with measurable metastatic melanoma, and a site that can easily be biopsied.

A Phase Ib/II, Multicenter, Open Label, Study of LEE011 in Combination with MEK162 in Adult Patients with NRAS Mutant Melanoma (2013-0185) (NCT01781572)  
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to find the highest tolerable dose of LEE011 that can be given with MEK162.

Induction of antitumor response in melanoma patients using the antimicrobial peptide LL37 (2013-0422) (NCT02225366)
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to find the appropriate dose of LL37 that can be given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the immune system to help control the disease.

Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients with Metastatic Melanoma (2012-1055)  (NCT02027935)
Principal Investigator: Cassian Yee, M.D.
The goal of this clinical research study is to learn about the safety of giving CD8+ T cells with ipilimumab, cyclophosphamide, and IL-2 (aldesleukin). Researchers also want to learn if this combination can help to control metastatic melanoma. 

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination with Nivolumab in Advanced/Metastatic Solid Tumors and B Cell Non-Hodgkins Lymphoma (2014-0651) (NCT02253992)
Principal Investigator: Vali Dimitrakopoulou, M.D.
Co-Principal Investigator: Adi Diab, M.D.
The goal of Part 1 of this study is to find the highest tolerable dose of urelumab and nivolumab when given in combination to patients with advanced solid tumors or B-cell NHL. The goal of Part 2 is to learn if the dose found in Part 1 can help to control melanoma, NSCLC, SCCHN, and/or DLBCL. The safety of this drug combination will be studied in both parts of the study. The goal of this part of the study (called "Continuation of Therapy") is to continue to study the effects of the study drug after the disease has appeared to get worse.

Patients with Uveal Melanoma

A Phase 2 Study of CDX-011 (Glembatumumab Vedotin) for Metastatic Uveal Melanoma (NCI9855) (NCT02363283)
Principal Investigator: Sapna P. Patel, M.D.
The primary objective of this study is to characterize the clinical anti-tumor activity of CDX-011 (glembatumumab vedotin) as a single agent in the treatment of patients with metastatic uveal melanoma. Secondary objectives include a description of the clinical safety and benefit of CDX-011 and pharmacodynamics changes in glycoprotein NMB (GPNMB) expression. Exploratory objectives include characterization of the anti-tumor immunophenotype of patients receiving treatment. Post hoc, correlation of rash with clinical benefit, or lack of rash with lack of benefit, will also be explored.

Phase II Study of Nivolumab in Combination with Ipilimumab for Uveal Melanoma (2011-0919) (NCT01585194)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to learn if ipilimumab and nivolumab can help to control uveal melanoma. Ipilimumab is designed to increase the immune system's ability to fight cancer. Nivolumab is an antibody (a protein that attacks foreign cells) that is designed to allow the body's immune system to work against tumor cells.