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Melanoma Clinical Trials

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.

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists for Resected Stage IIB-IV Melanoma (2014-0012) (NCT02126579)
Principal Investigator: Sapna Patel, M.D.
The goal of this clinical research study is to learn about the safety of giving
LPV7, polyICLC, resiquimod, and montanide ISA-51 to patients with melanoma. Researchers also want to learn if the study drugs cause any changes in the immune system. This is the first study of LPV7 in humans.

 

Chemotherapy-Naive Patients (no previous chemotherapy)

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: Patrick Hwu, 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.

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.

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: Rodabe Amaria, M.D.
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: 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 Phase I/II Clinical Trial to Study the Safety and Tolerability of MK-3475 Plus Pegylated Interferon alfa-2b (PEG-IFN) and MK-3475 Plus Ipilimumab (IPI) in Subjects with Advanced Melanoma (MEL) and Renal Cell Carcinoma (RCC) (Keynote 029) (2014-0032) (NCT02089685)
Principal Investigator: Wen-Jen Hwu, M.D., Ph.D.
The goal of this clinical research study is to find the highest tolerable dose of MK-3475 that can be given in combination with pegylated interferon alfa-2b (PEG-IFN). The safety of these drug combinations will also be studied.

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: Patrick Hwu, 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.

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.

Activation of pDCs at tumor and vaccine sites with TLR agonist (2008-0416) Phase II (NCT00960752)
Principal Investigators: Patrick Hwu, M.D. and Richard Royal, M.D.
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.

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, M.D., Ph.D.
There are 5 parts to this clinical research study. MD Anderson will be taking part in Parts B, D and F. The goal of Part B is to further test the highest tolerable dose of MK-3475 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 D is to study 2 dose levels of MK-3475 when given to patients with melanoma. The goal of Part F is to study 2 dose levels of MK-3475 when given to patients with lung cancer. 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: Michael Davies, M.D., Ph.D.
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: Sapna Patel, M.D.
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: Sapna Patel, M.D.
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.

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, M.D., Ph.D.
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.

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: Sapna Patel, M.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: 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.

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.

A Dose-Escalation, Phase I/II, Open-Label, Three-Part Study of the MEK Inhibitor, Trametinib, Combined with the CDK4/6 Inhibitor, Palbociclib, to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity in Subjects with Solid Tumors (2013-0793) (NCT02065063)
Principal Investigator: Michael A. Davies, M.D., Ph.D.
The goal of Part I of this clinical research study is to find the highest tolerable dose of trametinib combined with palbociclib that can be given to patients with solid tumors. The goal of Part 2 is to learn if the combination of trametinib and palbociclib can help to control the disease. The safety of this drug combination will also be studied.

Patients with Metastatic Uveal Melanoma

A Randomized Two-Arm Phase II Study of Trametinib Alone and in Combination with GSK2141795 in Patients with Advanced Uveal Melanoma (2013-0893) (NCT01979523)
Principal Investigator: Sapna P. Patel, M.D.
Uveal melanoma is a rare type of melanoma. It is very hard to treat once it has spread to other parts of the body. Dacarbazine, interleukin-2, vemurafenib, dabrafenib, trametinib and ipilimumab are the drugs approved to treat advanced melanoma by the Food and Drug Administration (FDA.) They sometimes work for skin melanoma,but have not been thoroughly tested in uveal melanoma. We are doing this study to try to find better treatments for your disease. The purpose of this study is to find out if treatment with trametinib alone or trametinib combined with GSK2141795 can stop your melanoma from growing. Trametinib and GSK2141795 are experimental drugs since they are not FDA-approved for uveal melanoma. An experimental drug is a medication that is not approved by the FDA to treat a specific condition. Trametinib is a pill that blocks a protein called MEK. Most uveal melanomas grow because of MEK overactivity. This overactivity occurs because a protein called Gnaq or Gna11 is abnormal in the majority of uveal melanomas. Blocking MEK may shut down this pathway and stop your cancer from growing. GSK2141795 is a pill that blocks a protein called AKT. AKT overactivity is also important for uveal melanoma to grow. Blocking both MEK and AKT together may be better than blocking MEK alone.


© 2014 The University of Texas MD Anderson Cancer Center