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Uveal Neoplasms clinical trials

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NCT ID: NCT04589832 Terminated - Uveal Melanoma Clinical Trials

Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma

Start date: January 11, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Single arm study with dose escalation Phase Ib cohort followed by a Phase II cohort. PAC-1 (PO) will be given daily on Days 1 through 21 of each cycle (28-day cycle). Entrectinib (PO) will be given daily on Days 1 through 28 of each cycle. Response will be evaluated after every 2 cycles. Treatment will continue until disease progression based on RECIST criteria or intolerable toxicity.

NCT ID: NCT04588662 Recruiting - Uveal Melanoma Clinical Trials

A Prospective Natural History Study in Uveal Melanoma

Start date: May 6, 2021
Phase:
Study type: Observational [Patient Registry]

The overall objective of this proposal is to develop and utilize a multicenter UM registry that will, in a longitudinal fashion, capture prospective data in order to characterize the natural history of UM and provide data that will be used to support the development of novel therapies for this disease. The care of patients with UM requires a multi-disciplinary team of physicians that commonly requires the involvement of both radiation oncology and interventional radiology, and is typically directed by an ophthalmologic oncologist at time of initial diagnosis of primary disease. Overall management is transitioned to a medical oncologist when distant recurrence is identified. In the case that a patient presents with metastasis at the time of diagnosis, a medical oncologist typically directs overall management. The management of surveillance for the development of metastasis following the treatment of primary disease is variable and, if performed at all, is managed by either an ophthalmologic oncologist or medical oncologist. Thus, the successful development of a registry that aims to capture the data regarding the full natural history of UM requires a collaborative effort including leaders from both the UM ophthalmologic oncology and medical oncology fields. To this end, the investigators have built an initial consortium of key ophthalmologic oncology and medical oncology leaders from multiple major UM centers in the United States.

NCT ID: NCT04577742 Completed - Uveal Melanoma Clinical Trials

Uveal Melanoma and Brachytheraphy: Long-term Outcomes.

Start date: February 1, 2011
Phase:
Study type: Observational

This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020

NCT ID: NCT04552223 Active, not recruiting - Clinical trials for Metastatic Uveal Melanoma

Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma

Start date: November 10, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this research is to test if a combination treatment of nivolumab and relatlimab will result in tumor reduction in patients with metastatic uveal melanoma.

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: NCT04424719 Recruiting - Uveal Melanoma Clinical Trials

Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

SALOME
Start date: July 8, 2020
Phase: N/A
Study type: Interventional

Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.

NCT ID: NCT04283890 Recruiting - Clinical trials for Uveal Melanoma, Metastatic

PHP and Immunotherapy in Metastasized UM

CHOPIN
Start date: December 4, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Melanoma of the eye (ocular/uveal melanoma) is an uncommon type of cancer that is associated with a high mortality. It usually disseminates rapidly throughout the body, most commonly to the liver and lungs. In this study a combination therapy with immunotherapy (ipilimumab with nivolumab) and chemotherapy (melphalan) will be assessed for the treatment of disseminated uveal melanoma. Melphalan will be administered selectively to the liver via percutaneous hepatic perfusion, limiting the systemic effect of chemotherapy. With this treatment combination we aim to find a treatment for disseminated uveal melanoma, both in the liver as in the other organs.

NCT ID: NCT04184518 Withdrawn - Metastatic Cancer Clinical Trials

Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma

CEDUVEAL-M
Start date: May 2020
Phase: Phase 2
Study type: Interventional

Phase II clinical trial aimed to evaluate the efficacy of the combination of cediranib and durvalumab in patients with metastatic uveal melanoma (mUM) with biopsiable disease at first line of after failure to first line systemic or liver directed therapy.

NCT ID: NCT04082962 Recruiting - Clinical trials for Exudative Retinal Detachment and Uveal Melanoma

Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

Start date: April 16, 2018
Phase: Phase 1
Study type: Interventional

This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision loss. Effective treatments for ERD are currently lacking. We are conducting this study to evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not approved for use in patients with UM and ERD. This study will determine the safety of the dexamethasone implant and provide preliminary evidence of efficacy in this population.

NCT ID: NCT03964298 Enrolling by invitation - Uveal Melanoma Clinical Trials

Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma

imMUno
Start date: November 2016
Phase:
Study type: Observational

Study of the activity of PD-1 inhibitors in metastatic uveal melanoma