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Melanoma clinical trials

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NCT ID: NCT06221397 Recruiting - Melanoma Clinical Trials

Clinical Validation Study of an AI-based CAD System for Early Non-Invasive Detection of Cutaneous Melanoma

LEGIT_MC_EVCDA
Start date: September 17, 2020
Phase:
Study type: Observational [Patient Registry]

The goal of this Cross-sectional analytical observational study of clinical case series is to validate a Computer-aided diagnosis software developed by AI Labs Group for the identification of cutaneous melanoma in images of lesions taken with a dermatoscopic camera. This study will be carried out in patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces University Hospital and Basurto University Hospital. The main questions it aims to answer are: - If the AI algorithm developed by AI Labs group is a valid tool to identify cutaneous melanoma in dermoscopic images with high reliability. - Comparing the device's performance with dermatologists, with primary care physicians' assessment to be considered in later phases. - Assessing the utility and feasibility of the device in adverse environments with technical limitations. In this way, patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces and Basurto University Hospitals will be recruited. Patients in this study will not receive any specific treatment as part of the research protocol. In addition, they will continue their regular prescribed medications and treatments as directed by their primary healthcare providers. This study does not require doing a follow-up of the subjects. Every patient only gets their skin lesions photographed at the time of visit.

NCT ID: NCT06216938 Recruiting - Melanoma Clinical Trials

RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis

Start date: February 2, 2024
Phase: Early Phase 1
Study type: Interventional

This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.

NCT ID: NCT06214156 Recruiting - Advanced Melanoma Clinical Trials

A Clinical Study of T3011 in Subjects With Advanced Melanoma

Start date: January 26, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

NCT ID: NCT06209580 Recruiting - Clinical trials for Advanced Solid Tumors

AMT-253 in Patients With Advanced Solid Tumours

Start date: January 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.

NCT ID: NCT06208124 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors

Start date: February 27, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations.

NCT ID: NCT06206707 Recruiting - Kidney Cancer Clinical Trials

FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

Immunobiome
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial. The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC. Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC. Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.

NCT ID: NCT06199713 Recruiting - Melanoma Clinical Trials

Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients

Start date: January 30, 2024
Phase:
Study type: Observational

The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.

NCT ID: NCT06194929 Recruiting - Melanoma Clinical Trials

Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

DETERMINE
Start date: February 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this interventional clinical trial is to provide proof-of-principle data for the biologic activity of defactinib in combination with avutometinib in brain metastases from melanoma, and to define the potential role of the combination with mutant BRAF inhibitors or after BRAF/MEK inhibitors in BRAF V600E/K mutant tumors, in individuals with advanced melanoma who experience the development or progression of brain metastases after treatment with immune checkpoint inhibitors. The main questions it aims to answer are: - What is the preliminary response rate of defactinib and avutometinib in patients with RAS mutant, BRAF mutant, NF1 mutant, triple RAS/BRAF/NF1 wild type (wt) melanoma (including RAF fusions)? - What is the safety and tolerability of the combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E/K mutant melanoma with at least one untreated brain metastases? - What is the preliminary response rate of the three drug combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E/K mutant melanoma.

NCT ID: NCT06172478 Recruiting - Prostate Cancer Clinical Trials

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

Start date: February 26, 2024
Phase: Phase 2
Study type: Interventional

This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma [cutaneous/acral], squamous cell carcinomas of the head and neck (SCCHN), and HER2-negative gastric cancerovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, and prostate cancer.

NCT ID: NCT06157099 Recruiting - Clinical trials for Clinical Stage IIA Cutaneous Melanoma AJCC v8

Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA Melanoma

Start date: April 22, 2024
Phase: Phase 2
Study type: Interventional

This clinical trial tests whether atorvastatin prevents metastasis of resected high-risk stage IIA melanoma.The vast majority of melanomas are diagnosed at an early, localized stage. However, approximately 10-15% of these localized melanomas will eventually metastasize, despite appropriate local treatment. Once metastasis occurs, median survival is less than two years. Melanomas at high risk of metastasis can be identified by gene expression profiling. Statin drugs, like atorvastatin, have been used to treat high cholesterol for the prevention of major adverse cardiovascular events, but not for preventing melanoma metastasis. Statins could prevent melanoma metastasis through decreasing tumor cell migration, decreasing tumor cell adhesion, and increasing immune system response. Statins are also efficient inhibitors of new lymphatic vessels formation. Since tumor lymphatic vessels serve as highways to lymph nodes and may suppress immune system responses, statins may block a critical step towards melanoma metastasis. Using atorvastatin may have the potential to prevent metastasis and improve outcomes in patients with resected high-risk melanoma.