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Melanoma clinical trials

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NCT ID: NCT01765556 Withdrawn - Clinical trials for Malignant Melanoma, Neoplasms

A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.

NCT ID: NCT01764009 Withdrawn - Melanoma Clinical Trials

Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma

AIMM
Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the present trial is: - to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. - to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP - to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

NCT ID: NCT01689870 Withdrawn - Metastatic Melanoma Clinical Trials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: NCT01593579 Withdrawn - Clinical trials for Diagnosis of Melanoma

Autonomic Phenotype Before and After Akt Inhibition

Start date: May 2012
Phase: N/A
Study type: Observational

Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.

NCT ID: NCT01531244 Withdrawn - Melanoma Clinical Trials

Isolated Limb Infusion Chemotherapy With Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma

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

This phase I/II trial studies the safety, best dose and effectiveness of targeted gene therapy combined with isolated limb infusion (ILI) of melphalan and dactinomycin for treating patients with advanced extremity melanoma that cannot be removed by surgery. Adding gene therapy to a standard chemotherapy regimen in the isolated limb may enhance anti-cancer effects by inducing a systemic immune response against the tumor cells.

NCT ID: NCT01455103 Withdrawn - Clinical trials for Stage III or IV Melanoma

Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma

PD-L1
Start date: November 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.

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: NCT01409187 Withdrawn - Melanoma Clinical Trials

IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma

Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

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 Intron-A (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) 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.

NCT ID: NCT01355562 Withdrawn - Melanoma Clinical Trials

Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.

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.