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Melanoma clinical trials

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NCT ID: NCT06291753 Completed - Clinical trials for Primary Malignant Melanoma of the Esophagus

Characteristics and Tumor Staging Proposal for Primary Malignant Melanoma of the Esophagus

Start date: September 22, 2023
Phase:
Study type: Observational

Background: Primary malignant melanoma of the esophagus (PMME) is a malignant tumor originating from esophageal melanocytes with a poor prognosis. No international clinical guidelines or tumor staging systems have been proposed for PMME. This study aimed to analyze the clinical characteristics and treatment outcomes of patients with PMME and propose a tumor staging system in PMME. Materials and Methods: The clinical characteristics of 25 patients with PMME at our cancer center were summarized, and 21 patients were enrolled in a pooled analysis with 162 cases (extracted from 74 eligible articles in PubMed) for further survival analysis and proposal of PMME tumor staging.

NCT ID: NCT06251934 Completed - Clinical trials for BRAF-positive Metastatic Melanoma

Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma

Start date: September 28, 2022
Phase:
Study type: Observational

This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x & ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.

NCT ID: NCT06189261 Completed - Melanoma Clinical Trials

Holistic Needs Assessments in Patients With Melanoma

Start date: February 2016
Phase:
Study type: Observational

This study will assess whether a needs assessment/management intervention for patients with malignant melanoma is achievable, reasonable, realistic and of value to patients with malignant melanoma and health professionals involved in their care. The study will also explore what the levels of patients' unmet needs are, whether unmet needs change over time, and what the potential effects of the intervention may be on patients' unmet needs, symptom severity, self-confidence in dealing with the illness, wellbeing, and satisfaction with the care received. In this study, the investigators will involve skin cancer nurse specialists, who will be asked to use an 'intervention questionnaire' to offer a needs assessment/management intervention to 30 people newly diagnosed with malignant melanoma. The investigators have used information from the literature to select the most appropriate 'intervention questionnaire' for this patient population. Each consenting patient (i.e. participant) will be expected to participate in the study over 4 months. During the study, two intervention consultations will take place 1 and 3 months after the initial clinical team meeting, where each participant's case will be discussed. At the start of each intervention consultation, participants will be asked to complete the intervention questionnaire. The recorded information will be passed to their nurse specialist, who will identify the participant's needs and offer tailored advice and support to meet these needs. Throughout the study, participants will also be asked to complete a set of questionnaires in the clinic (months 1 and 3) or at home (months 2 and 4) to explore potential effects of the intervention. A study evaluation form will be used at month 4 to collect participants' and health professionals' views on the intervention and how it was delivered. Face-to-face interviews will take place at the end of the study to explore participants' (a subset of 10 people) and health professionals' experiences with the intervention.

NCT ID: NCT06163170 Completed - Melanoma Clinical Trials

A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma

Start date: August 14, 2023
Phase:
Study type: Observational

The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated with adjuvant nivolumab after resection of stage IIB-IV melanoma. Demographic and clinical characteristics, and treatment patterns, will also be described in this population.

NCT ID: NCT06152367 Completed - Clinical trials for Stage IV Malignant Melanoma of Skin

Immunization With Autologous Dendritic Cells and Tumor Lysates in Melanoma Patients

Start date: January 30, 2001
Phase: Phase 1/Phase 2
Study type: Interventional

Implementing this protocol has its ethical justification in that patients with metastatic melanoma, once tumor invasion has reached beyond the lymph node barrier, cannot possibly be treated satisfactorily with traditional surgery methods, radiotherapy, or conventional available chemotherapy. The disseminated tumor is refractory to all standard treatments. Almost 100% of patients who develop distant metastases will die from their disease, either from complications or cachexia. Therefore, immunotherapy based on immunological stimulation with immunocompetent dendritic cells, added to immunological reinforcement with IL-2, can, according to the evidence emanating from ongoing clinical protocols, produce a prolongation of survival with better quality and, in some cases, with partial or total regression of the tumor. General objective: It is to study the clinical and immunological response of patients treated with vaccines based on autologous dendritic cells loaded with tumor antigens, derived from allogeneic melanoma extracts, in combination or not, with intercalated low doses of recombinant human interleukin 2 (rhIL2) PROLEUKIN ® (aldesleukin). MAIN SPECIFIC OBJECTIVE: - SAFETY: Safety in administering dendritic cell preparation; local and systemic toxicity estimation. Determination of adverse reactions such as fever, nausea, allergy, neurological and cardiovascular symptoms. Local toxicity in the administration area. - MEASUREMENT OF THE IMMUNE RESPONSE: Based on in vivo and in vitro parameters: - In vivo response: Measure the type IV Delayed Hypersensitivity (DTH) response. It consists of a crossover test in which the response is compared to tissue interaction in vivo between dendritic cells sensitized with tumor extracts and their respective control unloaded dendritic cells. - In vitro response: ELISPOT assays, measurement of IFN-γ gamma production in peripheral blood of treated patients. Compare the specific immune response after each cycle of therapy through measurement of IFN-γ production by tumor-specific CTL. Cytotoxic radioactive chromium release assays to measure anti-tumor response mediated by CTL and NK. ELISA assays for quantifying cytokines (IFN-γ, IL-10) in patient serum after each cycle of therapy.

NCT ID: NCT06046144 Completed - Melanoma Clinical Trials

Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors

Micro3
Start date: November 2, 2022
Phase:
Study type: Observational

Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature. In addition to RCM, we currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).

NCT ID: NCT05984615 Completed - Clinical trials for BRAF Positive Metastatic Melanoma

Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

Start date: June 8, 2022
Phase:
Study type: Observational

This was a retrospective real-world evidence cohort study.

NCT ID: NCT05874817 Completed - Melanoma Clinical Trials

Retrospective Assessment of AE-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Start date: May 1, 2021
Phase:
Study type: Observational

This was a retrospective cohort study using Truven Health Analytics' MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefit administrative claims databases. The analysis was conducted using the most recent 5 years of data from the database, 01 January 2015, to 28 February 2021 (study period). Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO] or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence of end of continuous eligibility or end of the study period.

NCT ID: NCT05817149 Completed - Surgery Clinical Trials

Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study

Start date: June 22, 2021
Phase:
Study type: Observational

We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made.

NCT ID: NCT05810740 Completed - Melanoma Clinical Trials

Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations

Start date: August 31, 2022
Phase: Phase 1
Study type: Interventional

The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial formulation of 15 mg was demonstrated. In order to reduce the patient's burden, a new strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x 15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the bioequivalence between one 45 mg tablet and three 15 mg tablets is therefore required.