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Melanoma Clinical Trials

For more information on these clinical trials, call the Information Line toll-free at 1-800-392-1611, or the Melanoma and Skin Center New Patient Referral at 713-563-9716.

(updated 1/10/2014)

Adjuvant

Phase I/II Study of Ipilimumab for Uveal Melanoma (2011-0919) (NCT01585194) 
Principal Investigator: Sapna P. Patel, MD
The goal of this clinical research study is to learn the highest tolerable dose of ipilimumab that can be given to patients with uveal melanoma. Researchers also want to learn if ipilimumab can help to control the disease. Ipilimumab is designed to increase the immune system's ability to fight cancer.

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients with Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence (2012-0437) (NCT01667419)
Principal Investigator: Kevin B. Kim, MD
The goal of this clinical research study is to learn if vemurafenib is effective in preventing melanoma from coming back in patients who have the BRAF mutation. The safety of vemurafenib will also be studied. In this study, some patients will receive vemurafenib and some patients will receive a placebo. Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and cancer growth. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.

Chemotherapy-Naive Patients (no previous chemotherapy)

Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High-Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy®) in Patients with Metastatic Melanoma (2013-0147) (NCT01856023)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to compare if and how long 2 different study treatment plans with aldesleukin (also known as interleukin-2 or IL-2) and ipilimumab may be able to help control metastatic melanoma. The safety of these treatment plans will also be studied.

IPI-Biochemotherapy for Chemonaive Patients with Metastatic Melanoma (2011-0073) (NCT01409174)
Principal Investigator: Agop Bedikian, MD
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer. Temozolomide 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. Cisplatin is designed to poison the cancer cells, which may cause them to die.

Phase II Study of Abraxane Plus Ipilimumab in Patients with Metastatic Melanoma (2011-1157) (NCT01827111)
Principal Investigator: Agop Bedikian, MD
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.

Trial of High Dose Interleukin-2 (HDIL-2) with Recombinant MAGE-A3 Protein Combined with Adjuvant System AS15 in Patients with Unresectable or Metastatic Melanoma (2010-0113) Phase II  (NCT01266603)
Principal Investigator: Wen-Jen Hwu, MD, PhD
The use of recombinant vaccines in combination with HDIL-2 may potentially increase response rates by stimulating the immune system. Patients with at least one biopsiable lesion and/or access to paraffin-embedded tissue block sample.

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, MD
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

T-Cells +/- Dendritic Cells (2004-0069) Phase II (NCT00338377)
Principal Investigator: Patrick Hwu, MD
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.

Activation of pDCs at tumor and vaccine sites with TLR agonist (2008-0416) Phase II (NCT00960752)
Principal Investigators: Patrick Hwu, MD and Richard Royal, MD
In this study, we are combining vaccines with a novel agent called resiquimod that can further stimulate the immune system. For patients with metastatic melanoma with measurable disease, Stage IIIC (in transit lesions) or Stage IV (M1A). Patients must be HLA-A201 and DP4 positive to participate and have at least 4 biopsiable lesions.  No previous exposure to gp100 or MAGE-3 peptide.

LOC-Paclitaxel  (2009-0432) Phase I (NCT01039844)
Principal Investigator: Agop Bedikian, MD
LOC-paclitaxel is a taxane prepared with fatty acids to enhance the uptake of paclitaxel by the tumor achieving higher concentrations over a prolonged period. Patients who have failed all conventional therapies and no other therapies are available. No CNS metastases allowed.

Phase I Study of Single Agent MK-3475 in Patients with Progressive Locally Advanced or Metastatic Carcinomas, Melanoma and Non-Small Cell Lung Carcinoma (2011-0757) (NCT01295827)
Principal Investigator: Wen-Jen Hwu, MD, PhD
There are three parts to this clinical research study. The goal of Part A was to find the highest tolerable dose of MK-3475 that can be given to patients with any type of carcinoma or melanoma. MD Anderson will not be taking part in Part A. The goal of Part B is to further test the highest tolerable dose that was found in Part A when given to patients with melanoma. The safety of this drug will also be studied. The goal of Part C is to test the highest tolerable dose of MK-3475 that can be given to patients with non-small cell lung cancer (NSCLC.) MK-3475 is a drug that includes a protein naturally created by living cells. It is designed to help the body’s natural defense system react against tumors by blocking proteins that cancer cells create to “turn off” the body’s immune (defense) system. This is the first study using MK-3475 in humans.

An Open-Label Phase II Study of the Combination of GSK2118436 and GSK1120212 in Patients with Metastatic Melanoma which is Refractory or Resistant to BRAF Inhibitor (2011-0579)  (NCT01619774)
Principal Investigator: Kevin B.Kim, MD
The goal of this clinical research study is to learn if the combination of two drugs (GSK2118436 and GSK1120212) can help to control melanoma. The safety of this drug combination will also be studied. GSK2118436 is designed to block the mutated BRAF protein. This mutation is only found in moles of the skin and in melanoma cells. By blocking the protein, the drug may slow the growth of or kill cancer cells that have the protein. GSK1120212 is designed to block certain proteins that cause cancer cells to grow and multiply. This may cause the cancer cells to die.

Phase I/II Study of the Combination of Doxycycline with Temozolomide and Ipilimumab in Patients with Metastatic Melanoma (2011-1165) (NCT01590082)
Principal Investigator: Kevin B. Kim, MD
The goal of this clinical research study is to find the highest tolerable dose of doxycycline that can be combined with temozolomide and ipilimumab in patients with advanced melanoma. The safety and level of effectiveness of the study drug combination will also be studied.

A Phase IB/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination with MEK162 in Adult Patients with BRAF V600-dependent Advanced Solid Tumors (2012-0238) (NCT01543698)
Principal Investigator: Kevin Kim, MD
The goal of Phase IB of this clinical research study is to find the highest tolerable dose of the targeted therapy drugs called LGX818 and MEK162 that can be given to patients with advanced colorectal cancer or melanoma that has a mutation (genetic change) called BRAF. Only melanoma patients with the BRAF mutation will be enrolled at MD Anderson. The goal of Phase II of this clinical research study is to learn if the highest tolerable dose combination of LGX818 and MEK162 can help to control advanced colorectal cancer and/or melanoma with BRAF mutations. The safety of the study drug combination will also be studied. LGX818 is designed to block chemical reactions in cancer cells that are needed for tumor cells to grow, survive, and form the blood vessels needed for tumor growth. This may cause the cancer cells to die. MEK162 is designed to block certain proteins that cause cancer cells to grow and multiply. This may cause the cancer cells to die.

An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects with Advanced Melanoma (Unresectable or Metastatic) (2012-0308) (NCT01621490)
Principal Investigator: Wen-Jen Hwu, MD, PhD
The goal of this clinical research study is to learn about the effects of nivolumab BMS-936558 on patients with advanced melanoma. The safety of this drug will also be studied. BMS-936558 is designed to help the immune system fight tumor cells.

A Phase I/IB Study for the Evaluation of SAR260301, Administered Orally in Monotherapy in Patients with Advanced Solid Tumors or Lymphomas, and in Combination with Vemurafenib in Patients with Unresectable/Metastatic BRAF Mutated Melanoma (2012-0470) (NCT01673737)
Principal Investigator: Michael Davies, MD, PhD
The goal of this clinical research study is to learn the highest tolerable dose of the drug SAR260301 when it is given alone or in combination with vemurafenib. The safety of this drug will also be studied.

A Phase I Study to Evaluate the Safety, Tolerability and Effectiveness of MK-8353 (formerly SCH 900353) in Subjects with Advanced Tumors (2012-0178) (NCT01358331)
Principal Investigator: Wen-Jen Hwu, MD, PhD
The goal of this clinical research study is to learn if MK-8353 can help to control colorectal cancer and/or melanoma. MK-8353 is designed to control an enzyme. If this enzyme is controlled, it may help stop the growth of cancer cells. 

Systemic Therapy of Metastatic Melanoma with Multidrug Regimen Including Interferon, Interleukin-2 and BRAF Inhibitor (2011-0847) 
(NCT0160312)
Principal Investigator: Rodabe N. Amaria, M.D.
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied. The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma. 

Phase I Study of the BRAF Inhibitor Dabrafenib +/- MEK Inhibitor Trametinib in Combination with Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma (2012-0976)  (NCT01767454)
Principal Investigator: Michael Davies, M.D., Ph.D.
The goal of this clinical research study is to find the highest tolerable dose of the combination of dabrafenib and ipilimumab that can be given with or without trametinib to patients with metastatic melanoma that is positive for the BRAF mutation. Mutations are abnormal changes in the DNA, the genetic material in the cells of the body. Dabrafenib is designed to block the mutated BRAF protein. By blocking the protein, the drug may slow the growth of or kill cancer cells that have the protein. Trametinib is designed to block certain proteins that cause cancer cells to grow and multiply. This may cause the cancer cells to die, especially in cells with BRAF mutation. Ipilimumab is designed to increase the immune system's ability to fight cancer. The drug blocks a molecule that is believed to shut down the part of the immune system that attacks cancer cells.

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: Kevin B. Kim, M.D.
The goal of this clinical research study is to find the highest tolerable dose of LEE011 that can be given with MEK162.

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MED14736 in Subjects with Advanced Solid Tumors (2012-0513) (2013-0814) (NCT01693562)
Principal Investigator: Wen-Jen Hwu, M.D., Ph.D.
The goal of this clinical research study is to learn about the safety of MED14736 when given to patients with advanced solid tumors.

An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf ®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation (2012-1049) (NCT01841463)
Principal Investigator: Kevin B. Kim, M.D.
The goal of this research study is to find the highest tolerable dose of P1446A-05 that can be given with vemurafenib to patients with advanced melanoma.

Patients with Metastatic Uveal Melanoma

Phase I/II Study of Ipilimumab for Uveal Melanoma (2011-0919) (NCT01585194) 
Principal Investigator: Sapna P. Patel, MD
The goal of this clinical research study is to learn the highest tolerable dose of ipilimumab that can be given to patients with uveal melanoma. Researchers also want to learn if ipilimumab can help to control the disease. Ipilimumab is designed to increase the immune system's ability to fight cancer.

Patients with Brain Metastases

N/A


© 2014 The University of Texas MD Anderson Cancer Center