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Melanoma clinical trials

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

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Start date: June 12, 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: NCT06041724 Not yet recruiting - Clinical trials for Advanced Mucosal Melanoma

Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma

Start date: September 18, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. At the same time, the tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, ctDNA and other biomarkers and the results were analyzed to find the predictive factors of prognosis or curative effect. Patients with advanced mucosal melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in this study and received 6 cycles of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin. Patients without progression were then maintained with Envafolimab combined with recombinant human endostatin until disease progression, intolerable adverse reactions, patient death or withdrawal of informed consent. The longest administration time of recombinant human endostatin was no more than 1 year, and that of Envafolimab was not more than 2 years. The efficacy was evaluated for the first time at 6 weeks, every 6 weeks for the following year, and then every 12 weeks until the end of progress or treatment. The examination method was consistent with the baseline; it was expected to be included in the group for 18 months, and clinical observation until disease progression and patient death.

NCT ID: NCT06030037 Not yet recruiting - Clinical trials for PD-1 Refractory Advanced Melanoma

Pembrolizumab/Lenvatinib With and Without Responder-derived FMT in Relapsed/Refractory Melanoma

Start date: July 31, 2024
Phase: Phase 2
Study type: Interventional

In this is a randomized phase II study the addition of R-FMT to pembrolizumab /lenvatinib in PD-1 R/R melanoma will be evaluated over a 104-week period in patients with anti-PD-1 R/R disease. Patients with PD-1 refractory advanced melanoma are eligible to enroll, excluding patients with prior lenvatinib (or other TKI) exposure. Intestinal microbiome composition mediates response to anti-PD-1 by affecting systemic inflammatory tone.

NCT ID: NCT06008106 Not yet recruiting - Melanoma Clinical Trials

Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma

Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.

NCT ID: NCT05983237 Not yet recruiting - Melanoma Clinical Trials

Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma

Start date: August 31, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate how well fuzoparib in combination with camrelizumab and temozolomide works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration.

NCT ID: NCT05903937 Not yet recruiting - Uveal Melanoma Clinical Trials

Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases

HAITILS-PHP
Start date: December 31, 2023
Phase: Phase 1
Study type: Interventional

Evaluate the safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion and preconditioning with percutaneous hepatic perfusion in patients with liver metastases (but not restricted to) of malignant melanoma

NCT ID: NCT05900102 Not yet recruiting - Melanoma Clinical Trials

EVALUATING THE CURRENT STANDARD OF CARE FOR PATIENTS DIAGNOSED WITH MALIGNANT MELANOMA OF THE HEAD AND NECK - ACCESS TO STAGING AND SURGICAL TREATMENT

Start date: August 1, 2023
Phase:
Study type: Observational

Melanoma is a serious type of skin cancer and is the 5th most common cancer in the United Kingdom (UK). It can affect anywhere on the skin including on the head and neck. The cancer often is first noticed as an abnormal mole. Treatment is by removing the cancer with surgery. Early spread of the cancer can be found by testing nearby glands called lymph nodes. This operation is called a sentinel lymph node biopsy (SLNB). If the cancer has spread then new treatments, such as immunotherapy, can be given to help the person live for longer. The sentinel lymph nodes are usually in the armpits or groin for melanoma on the body, arms or legs. For cancers in the head and neck the sentinel lymph nodes will usually be in the neck. For several reasons SLNB in the neck is not offered in every hospital that manages patients with melanoma. The problem with this is that some patients who could benefit are not offered the new treatments that extend life because it is not known that their cancer has spread. In this study we aim to gather national data on the management of melanoma of the head and neck including variation in practice between different hospitals. We will use routinely collected anonymous data called 'Hospital Episode Statistics' to look at who is offered SLNB after melanoma of the head or neck, what treatments they have, if their melanoma comes back and how long they survive for. By doing this, we hope to identify whether SLNB should be made available to everyone diagnosed with melanoma of the head and neck.

NCT ID: NCT05856565 Not yet recruiting - Metastatic Melanoma Clinical Trials

Generation of an Artificial Intelligence Algorithm Based on the Analysis of Melanoma Peri-scar Dermatoheliosis, as a Predictive Factor of Response to Anti-PD-1

HELIOPREDICT
Start date: May 15, 2023
Phase:
Study type: Observational

In the last decade, the advent of immunotherapies with inhibitors of immune checkpoints, such as anti-PD-1 and anti-CTLA-4, has revolutionized the treatment of advanced or metastatic melanoma. However, the clinical benefit remains limited to a subset of patients. Identifying the patients most likely to benefit from these novel therapies (and avoiding unnecessary toxicity in non-responding patients) is therefore critical. Previous studies found a significant link between the high mutational load of a tumor (TMB) and its response to anti-PD-1 monotherapy, regardless of the histological type of cancer. Unfortunately, TMB measurement is expensive, and requires extensive sequencing approaches difficult to implement in clinical practice. I have shown that melanomas known to be secondary to mutagenic ultraviolet rays (UVR) often carry a high TMB. The cumulative UVR damage translates into visible stigmas termed "dermatoheliosis" on patients' skin, easy to recognize with the naked eye of the clinician around the scar of the primary melanoma. My project proposes to establish, for the first time, dermatoheliosis as a novel predictive factor of response to anti-PD-1 immunotherapy, to be used within multidisciplinary tumor boards as a powerful decision-support tool to select the best treatment option. Specifically, I will 1) develop, validate and test in a prospective manner, an artificial intelligence (AI)-based algorithm, to assess features of pericicatricial dermatoheliosis based on a collection of photographs obtained from patients with unresectable locally advanced or metastatic melanoma 2) demonstrate the link between dermatoheliosis, TMB, immune and treatment response by characterizing pericicatricial skin single cell transcriptomics, as well as tumor DNA, RNA and host immunological profiles of the patients. This directly accessible, non-invasive, surrogate marker for TMB will be a game changer in clinical practice and will subsequently be translated to other skin cancers.

NCT ID: NCT05854589 Not yet recruiting - Melanoma (Skin) Clinical Trials

Effect of Topical Application of Hypertonic Saline on Melanoma on Its Sizes and Number.

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This study evaluates the effectiveness of applying Hypertonic Saline solution directly on the Melanomas in reducing their sizes and/or number.

NCT ID: NCT05827770 Not yet recruiting - Melanoma Stage III Clinical Trials

The Efficacy and Safety of Neoadjuvant Toripalimab Combined With Temozolomide in Resectable Stage III Melanoma

Start date: May 1, 2023
Phase: Phase 2
Study type: Interventional

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