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Metastatic Melanoma clinical trials

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NCT ID: NCT03155217 Completed - Metastatic Melanoma Clinical Trials

Tolerance of Targeted Therapy Used in Metastatic Melanoma in Patients Aged Over 65 and 75-year-old

TOLBRIPA
Start date: May 5, 2017
Phase:
Study type: Observational

Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. These patients are still active but much more vulnerable. Nevertheless, there is no data in the literature for this fragile population except the MM pivotal studies subgroups of those over 65-year-old. The results vary with different regimens. Therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK inhibitors in elderly patients

NCT ID: NCT03123783 Completed - Cancer Clinical Trials

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Start date: July 10, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.

NCT ID: NCT02862743 Completed - Metastatic Melanoma Clinical Trials

Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

MELCIRC
Start date: January 14, 2016
Phase: N/A
Study type: Interventional

Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies. In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

NCT ID: NCT02858869 Completed - Metastatic Melanoma Clinical Trials

Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases

Start date: October 4, 2016
Phase: Phase 1
Study type: Interventional

This pilot trial studies the side effects of giving pembrolizumab together with stereotactic radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Giving pembrolizumab together with stereotactic radiosurgery may be a better treatment for patients with melanoma or non-small cell lung cancer that has spread to the brain.

NCT ID: NCT02857270 Completed - Colorectal Cancer Clinical Trials

A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer

Start date: September 29, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.

NCT ID: NCT02791594 Completed - Metastatic Melanoma Clinical Trials

Imaging FDG Flare in Melanoma

Start date: June 2016
Phase:
Study type: Observational

Up to 35 adult patients with metastatic melanoma will be enrolled in this study with a target enrollment of 30 evaluable subjects who complete the baseline and an approximately 3 week FDG PET/CT scans, they may also complete an FDG PET/CT after 10 weeks of pembrolizumab therapy. Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be asked to have one additional tumor biopsy and one additional blood draw for the purposes of this imaging study. Subjects who are eligible for this imaging protocol will undergo a baseline FDG PET/CT scan as part of their clinical restaging prior to starting new therapy. A research FDG PET/CT will take place approximately 3 weeks post-therapy and a 3rd FDG PET/CT scan will be done at more than 10 weeks after starting pembrolizumab, this scan may be done as a clinical scan for evaluation of response or restaging after therapy, however, if it is not ordered as a clinical scan it will be done as a research scan. Changes in FDG uptake will be correlated with blood and tissue results from the patient's medical records and from the data collected as part of the Penn Melanoma Tissue Collection Program and with long term outcomes including progression free and overall survival.

NCT ID: NCT02768207 Completed - Metastatic Melanoma Clinical Trials

A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

Start date: May 23, 2016
Phase: Phase 2
Study type: Interventional

This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib. The length of the study will be approximately 38 months.

NCT ID: NCT02755233 Completed - Metastatic Melanoma Clinical Trials

Ipilimumab-induced Lung Toxicity: Observational Study

Ipi-Lu-Tox
Start date: January 2014
Phase: N/A
Study type: Observational

Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM before and during treatment with ipilimumab are performed. A reduction from baseline of forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus indicative for pulmonary toxicity.

NCT ID: NCT02713269 Completed - Sarcoma Clinical Trials

Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord

Start date: August 29, 2016
Phase: Phase 2
Study type: Interventional

This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

NCT ID: NCT02700971 Completed - Metastatic Melanoma Clinical Trials

RATIO: Rational Approach To Immuno-Oncology

RATIO
Start date: June 23, 2016
Phase: N/A
Study type: Interventional

This trial will utilize a Molecular MicroscopeTM diagnostic system (MMDxTM) that combines the molecular and histopathological features of biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. This MMDxTM will be utilized to phenotype cutaneous melanoma biopsy samples to detect an immune responsive mRNA signature.