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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. 

 

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.

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: Patrick Hwu, 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.

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

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.   

Expanded Access Program with Nivolumab (BMS-936558) in Combination with Ipilimumab (Yervoy) in Anti-CTLA-4 Treatment-Naive Subjects with Unresectable or Metastatic Melanoma (2014-0639) (NCT02186249)
Principal Investigator: Sapna Patel, M.D.
The goal of this clinical research study is to provide access to nivolumab, given in combination with Yervoy™ (ipilimumab), to patients with metastatic or unresectable melanoma. Researchers also want to learn if this drug combination can help to control the disease. The safety of the drug combination will also be studied.

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.

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: Patrick Hwu, 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.

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/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.

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.


© 2015 The University of Texas MD Anderson Cancer Center