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Metastatic Melanoma clinical trials

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NCT ID: NCT03297463 Withdrawn - Metastatic Melanoma Clinical Trials

Radiation Therapy With Combination Immunotherapy for Relapsed/Refractory Metastatic Melanoma

Start date: January 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2 study designed to evaluate combination of the human T-cell cytokine Interleukin-2 (IL-2) and a checkpoint inhibitor Ipilimumab immediately following a course of hypofractionated palliative radiation therapy in the management of unresectable, relapsed/refractory metastatic melanoma.

NCT ID: NCT03126461 Withdrawn - Melanoma Clinical Trials

SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients

Start date: March 1, 2018
Phase: Phase 2
Study type: Interventional

A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients

NCT ID: NCT02489266 Withdrawn - Metastatic Melanoma Clinical Trials

In Vivo Persistence of Adoptively-Transferred TIL Cultured With Akti in People With Metastatic Melanoma

Start date: June 24, 2015
Phase: Phase 1
Study type: Interventional

Background: - One cancer therapy involves taking white blood cells from a person, changing them in a lab, and then giving the cells back to the person. These cells are called tumor infiltrating lymphocytes (TIL). Researchers want to grow some of the TIL cells with the drug Akti to see if they live longer than those grown without it. Objectives: - To see if TIL cells grown with Akti live longer than those grown without it. Eligibility: - Adults 18 70 with metastatic melanoma Design: - Participants will: - Be screened with tests including scans, x-rays, heart and lung tests, blood and urine tests, and a <TAB>possible colonoscopy. - Have tumor surgery or biopsy. - Have a large catheter inserted into a vein in the upper chest. - Receive leukapheresis for 4 5 hours. Blood is removed through a needle in an arm. White blood cells <TAB>are removed. The rest of the blood is returned by needle in the other arm. - The cells will be changed in a laboratory. - Participants will check into the hospital and: - For 5 days, get 1 2 chemotherapy drugs by catheter. - For 1 3 days, get the changed cells by catheter. - For several days, get 2 drugs to stimulate cells, one by injection, the other by catheter. - For 7 12 days, recover in the hospital. - After treatment, participants will: - Take an antibiotic and antiviral for at least 6 months. - Return to NIH for several 2-day visits for a few years. At each visit, participants will have lab tests, imaging studies, and a physical exam. At some visits, they may have leukapheresis or blood tests.

NCT ID: NCT02357732 Withdrawn - Metastatic Melanoma Clinical Trials

Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib

Start date: August 2015
Phase: Phase 1
Study type: Interventional

This study evaluates nivolumab in combination drug treatments involving 1) nivolumab and dabrafenib 2) nivolumab and trametinib and 3) nivolumab, dabrafenib and trametinib in patients with BRAF or NRAS-mutated metastatic melanoma.

NCT ID: NCT02065466 Withdrawn - Metastatic Melanoma Clinical Trials

Combo of Abraxane, TMZ, Bevacizumab in Metastatic Melanoma With Brain Metastases

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

1.1. Primary Objectives 1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma. - To define the MTD of the combination (Phase I component). - To determine progression free survival (Phase II component). 1.2. Secondary Objectives 1. To separately evaluate the response rate and duration of both the brain and extra-cranial systemic metastases. 2. To define the toxicity of the regimen. 3. To tabulate the toxicity of the radiotherapy to the brain and compare with known toxicities of radiotherapy to the brain in melanoma and brain metastases. 4. To use the data generated to plan definitive controlled clinical trials of the combination. 5. To determine the overall response rate (Phase II component).

NCT ID: NCT01933061 Withdrawn - Metastatic Melanoma Clinical Trials

Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma

Start date: January 2014
Phase: Phase 2
Study type: Interventional

A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.

NCT ID: NCT01833767 Withdrawn - Metastatic Melanoma Clinical Trials

Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.

NCT ID: NCT01689870 Withdrawn - Metastatic Melanoma Clinical Trials

Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, two-phase study combining a dose escalation Phase 1 with a proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated. The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor response assessed by the Immune-related Response Criteria. The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.

NCT ID: NCT01416844 Withdrawn - Metastatic Melanoma Clinical Trials

Study of Immune Responses in Patients With Metastatic Melanoma

Start date: September 2012
Phase: Phase 2
Study type: Interventional

In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.

NCT ID: NCT01340729 Withdrawn - Metastatic Melanoma Clinical Trials

Open-Label Study of TPI 287 for Patients With Metastatic Melanoma

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical research study is to find the highest tolerable dose of TPI 287 that can be given to patients with metastatic melanoma. Researchers want to find out if TPI 287 can control the disease. The safety of TPI 287 will also be studied.