Active clinical trials for "Melanoma"

Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people. Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%. For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 ~ 11 months. Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.

Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice. Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.

Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk stage III (stage IIIA [lymph node > 1mm], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey.

The intent of this study is to evaluate the actionable information output from the TRAQinform Immuno technology in a prospective, non-interventional clinical study. Subjects with metastatic melanoma treated with standard of care (SOC) dual-agent immunotherapy will be enrolled. Subjects will receive SOC immunotherapy monitored for treatment response with FDG PET/CT's at baseline (SOC), after 3-4 weeks of treatment (non-SOC) and 12 at weeks of treatment (SOC).

This study is being conducted to explore the efficacy and safety of neoadjuvant toripalimab combined with temozolomide in resectable stage III melanoma.

Background The purpose of this study is to describe the profile of patients with BRAF-mutated melanoma treated with BRAF/MEK inhibitors combination and using the Tavie Skin application. TavieSkin app, a digital solution developped by Pierre Fabre, is dedicated to all BRAF-mutant unresectable or metastatic melanoma patients who are treated with "any" targeted therapies. Study objectives The primary objective of the survey is to describe the demographics and clinical characteristics of patients with unresectable or metastatic BRAF-mutated melanoma treated with targeted therapy (BRAFi/MEKi) and using the TavieSkin application The secondary objectives include: To assess the use of TavieSkin app in patients with unresectable or metastatic BRAF-mutated melanoma treated with BRAFi/MEKi combination; To assess the treatment adherence of patients using TavieSkin app including treatment interruption or permanent discontinuation; To assess the health-related quality of life of patients using TavieSkin app (FACT-M); To assess work productivity and activity impairment over the treatment duration To assess the patient satisfaction toward the TavieSkin application; To assess the patient satisfaction toward the treatment. Research methods 3.1 Study design This prospective, longitudinal, survey will be conducted in Europe to characterize BRAF-mutant unresectable or metastatic melanoma patients using TavieSkin app designed for accompanying patients treated with targeted therapies. To date, there are three combinations of BRAFi/MEKi available in routine practice for the treatment of BRAF-mutant unresectable or metastatic melanoma. The survey does not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physicians in accordance with their usual practices. The patients initiating any BRAFi/MEKi combination will be invited to use the TavieSkin app by their healthcare provider (HCP) (i.e. oncologist, dermatologist, nurse…). Once the patient has installed and started to use the application, an e-survey will be proposed to the patient via the app. A detailed information letter about the data collection, data privacy and analysis will be displayed to the patient via the app along with an e-consent for data collection. The patient will be able then to provide an e-signature, if he/she accepts to take part of this survey. The survey will collect anonymized data about health status, QoL data and satisfaction. These data will be collected by the patient only. The physician will not be involved in this e-survey (including e-consent), nor in data collection. Only patients having given consent (e-consent) to data collection and analysis will be included. Data will be collected at baseline and at different subsequent timepoints during the BRAFi/MEKi treatment duration only. Only data reported by the patients in the application will be collected and analyzed. The patient will discontinue the study in case of definitive withdrawal of BRAFi/MEKi treatment, or if he/she decides to withdraw the study and to stop data collection. The target countries for patient enrollment will include Germany, Belgium, Portugal, France, Spain, Italy and Sweden with the additional possibility of including patients from other EU countries. At least, 400 adult patients (≥18 years) will be enrolled. 3.2 Population (see section: Eligibility) 3.3 Study outcomes (see section: Outcome measures) 3.4 Statistical considerations Statistical analyses will be fully described in a written statistical analysis plan (SAP). The study endpoints will be analysed overall and by country. Analyses will be descriptive in nature, as no hypothesis will be tested. The treatment patterns of patients, baseline demographics and clinical characteristics, and reasons for treatment discontinuation will be described using summary statistics. Categorical variables will be summarized by frequencies and percentages. Continuous variables will be summarized by descriptive statistics (mean, and standard deviation, median, 25th and 75th percentiles, minimum and maximum). The number of missing observations for each variable will also be reported. Change in health-related quality-of-life scores (i.e. (FACT-M) will be summarised at baseline and at each timepoints. The change from baseline will be assessed using a mixed model for repeated measures (MMRM). Time to event data (i.e. time to treatment discontinuation, time QoL deterioration) will be evaluated using Kaplan-Meier survival curves. Median survival estimates will be reported along with the 25th and 75th percentiles and corresponding 95% confidence intervals (CIs). Cox regression analysis may be performed to adjust for predefined (baseline) covariates. If the sample size is adequate, subgroup analyses using variables at baseline might be conducted.

This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogenic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogenic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.

This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy, and to learn if there are any relationships between these side effects and immune and genetic biomarkers found in the blood that may be related to patient's reaction to immunotherapy.

This study will enroll metastatic (Stage IV or inoperable stage III) melanoma (MM) patients carrying a BRAF V600E/K mutation with confirmed primary resistance to standard of care immunotherapy (single agent PD-1 or a combination of CTLA-4/PD-1 blockade). Patients must be naïve to therapy with BRAF+MEK inhibitors, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For investigators' current experimental clinical trial, patients are given 4 injections of ipilimumab, given 3 weeks apart x 4 injections with or without cytokine-induced killer therapy. Investigators propose to test this dual therapy in patients with melanoma who have known stage I, metastatic melanoma. Investigators hypothesize that this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of progression-free, disease-free or overall survival compared to the use of ipilimumab alone