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Advanced Melanoma clinical trials

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NCT ID: NCT02402699 Completed - Hepatitis C Clinical Trials

Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

Yervoy RMP
Start date: December 15, 2015
Phase:
Study type: Observational [Patient Registry]

This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.

NCT ID: NCT02224768 Completed - Advanced Melanoma Clinical Trials

YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

Start date: July 2015
Phase: N/A
Study type: Observational

To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients

NCT ID: NCT02177110 Completed - Metastatic Melanoma Clinical Trials

A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma

SYS-ACT
Start date: September 2014
Phase:
Study type: Observational

This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average. Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments. The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.

NCT ID: NCT02171286 Completed - Clinical trials for Colorectal Cancer Metastatic

The Oncopanel Pilot (TOP) Study

Start date: October 2014
Phase: N/A
Study type: Observational

The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.

NCT ID: NCT01621490 Completed - Metastatic Melanoma Clinical Trials

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

PD-1
Start date: September 27, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)

NCT ID: NCT01618136 Completed - Ovarian Cancer Clinical Trials

An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid Tumors

Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Overall Design: This is a multicenter, open-label, Phase 1/2 study which will be conducted in three arms (as described below). Each arm will be conducted in two parts: a Phase 1 part which will include dose escalation and a Phase 2 part which will include four cohorts in specific disease indications. Phase 1 will also include a food effect study of E7449 as a single agent. Once the MTD in the Phase 1 single agent arm and the Phase 1 combination arms of this study has been achieved, the sponsor will submit the relevant safety information and recommended Phase 2 dose to the IRB/Health Authorities. Arm 1: E7449 will be administered as a single agent. Arm 2: E7449 will be administered in combination with TMZ. Arm 3: E7449 will be administered in combination with carboplatin and paclitaxel

NCT ID: NCT01614301 Recruiting - Advanced Melanoma Clinical Trials

Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma

Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma Phase I: To determine the dose of temsirolimus to be used in phase II part of the study Phase II: To determine overall survival Secondary objectives - To evalulate response rate - To evaluate time to progression (TTP) - To evalulate time to partial response (time to PR or better)(TPR) - To evaluate quality of life - To evaluate tolerability and safety

NCT ID: NCT01453361 Terminated - Advanced Melanoma Clinical Trials

Phase II FANG™ in Advanced Melanoma

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

Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, the investigators have designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen to immunogen), effector potency, and cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer vaccines, the investigators designed a novel dual-modulatory autologous whole cell vaccine, Vigil™ (bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine), incorporating the rhGMCSF (recombinant human GMCSF) transgene and the bifunctional shRNAfurin (to block proprotein conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer associated antigens, 2) effect antigen recognition by the immune system (i.e. antigen to immunogen), 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune resistance. The investigators have also completed the Phase I assessment of Vigil™ vaccine in 27 advanced solid tumor patients (1.0 x 10e7 or 2.5 x 10e7 cells/injection/month for a maximum of 12 vaccinations) who have not experienced any significant adverse effects following 131 vaccinations, including 4 patients with melanoma. Plasmid functionality, immune biomarker response, and preliminary evidence of anticancer activity have been observed. This is a Phase II study of intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations) in patients with stages IIIc and IV melanoma with biopsy accessible lesions to document blood and intratumoral immune responses and assess correlation with survival.

NCT ID: NCT01212276 Terminated - Melanoma Clinical Trials

A Safety and MORAb-028 Dose Determination Study in Subjects With Metastatic Melanoma

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective, and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.

NCT ID: NCT01134614 Active, not recruiting - Metastatic Melanoma Clinical Trials

Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Start date: December 28, 2010
Phase: Phase 2
Study type: Interventional

This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.