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Uveal Melanoma clinical trials

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NCT ID: NCT05542342 Active, not recruiting - Uveal Melanoma Clinical Trials

Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.

SITISVEAL
Start date: September 23, 2022
Phase: Phase 2
Study type: Interventional

SITISVEAL stablish the hypothesis that treatment with Tislelizumab + Sitravatinib will increase the Objective Response Rate in patients with Metastatic Uveal Melanoma (mUM) with liver metastases, compared with the current standard of care. This is a non-randomized, single arm, multicenter, phase II study of Sitravatinib in combination with Tislelizumab in subjects with metastatic uveal melanoma and liver metastases. After informed consent is obtained, subjects will enter in the Screening phase to assess eligibility criteria and perform a mandatory tumor biopsy. Upon meeting criteria, eligible subjects will be entered into the Treatment phase. Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.

NCT ID: NCT04463368 Active, not recruiting - Liver Metastases Clinical Trials

Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases

SCANDIUM II
Start date: March 8, 2021
Phase: Phase 1
Study type: Interventional

Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumour, metastatic disease will develop in approximately 35%-50% of the patients within 10 years. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. Isolated hepatic perfusion is a regional treatment where the liver is completely isolated from the systemic circulation, allowing a high concentration of chemotherapy to be perfused through the liver with minimal systemic exposure. The introduction of modern immunotherapy in the treatment arsenal for cutaneous melanoma also creates hope for patients with uveal melanoma metastases. However, the results of immunotherapy have so far been disappointing. The reason for the low efficacy could be that uveal melanoma develops in the immune privileged eye. The hypothesis in this trial is that isolated hepatic perfusion with melphalan causes an immunogenic type of cell death by local tumour destruction while leaving the immune-system intact. This will cause an activation of the immune-system and the addition of ipilimumab and nivolumab will enhance this effect, ultimately increasing the treatment efficacy. The primary objective of this trial is to evaluate the safety and tolerability of isolated hepatic perfusion together with ipilimumab and nivolumab when given at the same time or as a sequenced regimen. The study design is a phase I randomized controlled, multicentre, open-label trial. Active follow-up will be performed for 2 years. Patients will be randomized after diagnoses of metastatic disease to one of the following treatment arms: Arm A. Patients will be treated with IHP followed by 4 courses of ipilimumab 3mg/kg and nivolumab 1mg/kg every third week followed by continued nivolumab 480mg q4w up to 1 year. Arm B. Patients will be treated with 1 course of ipilimumab 3mg/kg and nivolumab 1mg/kg followed by IHP after 3 weeks and then another 3 courses of ipilimumab 3mg/kg and nivolumab 1mg/kg every third week followed by continued nivolumab 480mg q4w up to 1 year.

NCT ID: NCT04417530 Active, not recruiting - Uveal Melanoma Clinical Trials

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

NCT ID: NCT04364230 Active, not recruiting - Melanoma Clinical Trials

Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)

Mel66
Start date: September 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). The study will also investigate the effects of the vaccine and the adjuvants on the immune response. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and skin tissue.

NCT ID: NCT04328844 Active, not recruiting - NSCLC Clinical Trials

A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers

Start date: February 25, 2020
Phase: Phase 1
Study type: Interventional

The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis)

NCT ID: NCT03635632 Active, not recruiting - Uveal Melanoma Clinical Trials

C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)

Start date: April 23, 2019
Phase: Phase 1
Study type: Interventional

This study is for patients with neuroblastoma, sarcoma, uveal melanoma, breast cancer, or another cancer that expresses a substance on the cancer cells called GD2. The cancer has either come back after treatment or did not respond to treatment. Because there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body fight infection. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. In our last clinical trial we made a gene called a chimeric antigen receptor (CAR) from an antibody that recognizes GD2, a substance found on almost all neuroblastoma cells (GD2-CAR). We put this gene into the patients' own T cells and gave them back to 11 neuroblastoma patients. We saw that the cells did grow for a while, but started to disappear from the blood after 2 weeks. We think that if T cells are able to last longer they may have a better chance of killing GD2 positive tumor cells. Therefore, in this study we will add a new gene to the GD2 T cells that can cause the cells to live longer. T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. In other studies using T cells, investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells to expand and stay longer in the body, and potentially kill cancer cells more effectively. The GD2-C7R T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the largest safe dose of GD2-C7R T cells, and also to evaluate how long they can be detected in the blood and what affect they have on cancer.

NCT ID: NCT03417739 Active, not recruiting - Uveal Melanoma Clinical Trials

A Phase II Study of BVD-523 in Metastatic Uveal Melanoma

Start date: March 26, 2018
Phase: Phase 2
Study type: Interventional

This research study is studying a targeted therapy called BVD-523 as a possible treatment for advanced uveal melanoma.

NCT ID: NCT03070392 Active, not recruiting - Uveal Melanoma Clinical Trials

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Start date: October 16, 2017
Phase: Phase 2
Study type: Interventional

To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

NCT ID: NCT02913417 Active, not recruiting - Uveal Melanoma Clinical Trials

Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases

Start date: October 10, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Reports to date show limited efficacy of immunotherapy for uveal melanoma. Recent experimental and clinical evidence suggests synergy between radiation therapy and immunotherapy. The investigators will explore this synergy with a feasibility study of 26 patients with uveal melanoma and hepatic metastases who will receive SirSpheres Yttrium-90 selective internal hepatic radiation followed by immunotherapy with the combination of ipilimumab and nivolumab.

NCT ID: NCT02874040 Active, not recruiting - Uveal Melanoma Clinical Trials

Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Start date: April 19, 2013
Phase: N/A
Study type: Interventional

Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation