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Metastatic Melanoma clinical trials

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NCT ID: NCT06236360 Recruiting - Metastatic Melanoma Clinical Trials

Metastatic Melanoma Patients on Immunotherapy With Nutritive Intervention Based on Mediterranean Diet

MINI-MD
Start date: December 21, 2023
Phase: N/A
Study type: Interventional

This research will study the effect of Mediterranean diet intervention in patients undergoing immunotherapy treatment for metastatic melanoma and its relationship with gut microbiome and quality of life. One group of patients will continue with their regular diet, while the other will receive dietary tele-intervention with trained nutritionist during the 12-week period. Gut microbiome, quality of life questionnaires, blood parameters and radiological examination will be evaluated before and 12-weeks after the start of the intervention.

NCT ID: NCT06180460 Recruiting - Clinical trials for Metastatic Breast Cancer

CALM: Managing Distress in Malignant Brain Cancer

Start date: November 10, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.

NCT ID: NCT06151847 Recruiting - Metastatic Melanoma Clinical Trials

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma

Start date: December 21, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.

NCT ID: NCT06075524 Recruiting - Metastatic Melanoma Clinical Trials

Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types

Start date: June 15, 2015
Phase:
Study type: Observational

This study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.

NCT ID: NCT06066138 Not yet recruiting - Metastatic Melanoma Clinical Trials

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Start date: March 31, 2024
Phase: Phase 1
Study type: Interventional

Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects. Objective: To test different doses and timing of atezolizumab for people with cancer. Eligibility: People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug. Design: Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor. Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care. The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later. For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change. Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months. Study treatment may last up to 2 years.

NCT ID: NCT06060613 Recruiting - Lung Cancer Clinical Trials

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Start date: October 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.

NCT ID: NCT05954546 Active, not recruiting - Metastatic Melanoma Clinical Trials

A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings

Start date: July 21, 2023
Phase:
Study type: Observational

Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. And produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for future research studies. This study group is identified from the database who: - Have taken at least 1 order or administration of encorafenib plus binimetinib treatment after the confirmation of having metastatic melanoma after 27 June 2018. - Are at least 18 years of age at the time of first encorafenib plus binimetinib initiation (index date). - Had never received encorafenib plus binimetinib or had received first-line immunotherapy at the start of the study. - Have ECOG status of 0 or 1 at the index date. - have available data on the number of deaths in an area or group of people. Patients will be followed from the date that the patient started the first encorafenib plus binimetinib treatment (treatment initiation) up to their last date of data availability. Last date of data availability could be the date of following events: patient lost to follow up at the clinic, death, or end of the database (January 2020). The database timeframe is June 2018 to January 2020.

NCT ID: NCT05913388 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

Start date: February 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.

NCT ID: NCT05896839 Recruiting - Metastatic Melanoma Clinical Trials

Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer

Start date: August 11, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and ipilimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and ipilimumab in combination with sirolimus and prednisone may kill more cancer cells, while also keeping the transplanted kidney healthy, in patients with unresectable or metastatic cutaneous cancer who have received a kidney transplant.

NCT ID: NCT05878977 Recruiting - Metastatic Melanoma Clinical Trials

Biomarkers in Immunotherapy of Melanoma

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response. This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the study. Stool samples are submitted before the start of treatment, at the 12 (+/-2) week and 28 (+/-4) week, and at the event ( such as, suspected disease progression/hyperprogressio, immune related adverse event (irAE), etc). Peripheral venous blood samples are taken additionaly at the same time points for cytologic and molecular tests. Histological material from the tumor tissue is obtained before the start of immunotherapy treatment. Primary objectives are to determine whether human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ predict response to treatment with PD-1 and CTLA-4 inhibitors and are associated with occurrence of irAE in patients with metastatic melanoma at different time points. Response is evaluated radiologically with imaging methods in accordance with the irRECIST criteria. Conclussion: Despite the great success of the treatment of metastatic melanoma with immunotherapy, there remains a significant proportion of patients who do not respond to treatment or who develop severe adverse events during treatment. Identification of novel predictive and prognostic biomarkers for immunotherapy treatment response is therefore necessary. This study is the first to combine and investigate multiple potential predictive and prognostic biomarkers and its dynamics. The results could serve for a better and multi-level understanding of the various factors influencing immunotherapy treatment.