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Melanoma clinical trials

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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.

NCT ID: NCT05806268 Completed - Clinical trials for BRAF v600 Mutated Metastatic Melanoma

Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients

Start date: July 30, 2021
Phase:
Study type: Observational

This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x & ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation. No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.

NCT ID: NCT05740501 Completed - Melanoma Clinical Trials

Pharmacokinetic Profiling of Pembrolizumab and Nivolumab in Patients With Melanoma and/or Non-Small Cell Lung Cancer

Start date: April 26, 2017
Phase:
Study type: Observational

This early phase I study collects blood samples and monitors the levels of pembrolizumab and nivolumab as they move through the body in patients with melanoma and/or non-small cell lung cancer. Pembrolizumab and nivolumab are a monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Studying samples of blood in the laboratory from patients receiving pembrolizumab and nivolumab may help doctors learn more about the effects of pembrolizumab and nivolumab on cells. It may also help doctors understand how well patients respond to treatment. Information from this study may be used in the future to guide physicians to make dosage adjustments based on serum concentrations of drug to minimize adverse side effects and maximize the effect of the drug.

NCT ID: NCT05714371 Completed - Melanoma Clinical Trials

Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Start date: October 2, 2021
Phase:
Study type: Observational

This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. 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 or end of continuous eligibility or end of the study period.

NCT ID: NCT05661370 Completed - Melanoma (Skin) Clinical Trials

App Teaches Doctors to Diagnose Skin Cancer

Start date: November 15, 2021
Phase: N/A
Study type: Interventional

This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Secondarily the study aimed to investigate the time spent in reaching this change in proficiency.

NCT ID: NCT05611229 Completed - Metastatic Melanoma Clinical Trials

Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden

Start date: June 16, 2020
Phase:
Study type: Observational

This was an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset.

NCT ID: NCT05432622 Completed - Melanoma Clinical Trials

A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy

Start date: December 19, 2019
Phase:
Study type: Observational

The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.

NCT ID: NCT05426239 Completed - Advanced Melanoma Clinical Trials

Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database

Start date: January 9, 2019
Phase:
Study type: Observational

This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).

NCT ID: NCT05389085 Completed - Malignant Melanoma Clinical Trials

Fast Track Diagnosis of Skin Cancer by Advanced Imaging Technologies and Tumour Tapestripping

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

In this clinical feasibility study the investigators will test and compare two advanced optical imaging technologies, lipid and RNA tape stripping with regards to diagnostic accuracies for fast bedside diagnosis of pigmented skin tumours.