SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
Stage IV Uveal MelanomaThe purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. This radiation may cause the tumor cells to die.
Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma
Uveal MelanomaPatients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA. 200 patients will be included. The Trial is an open multicenter Phase III Trial.
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Uveal MelanomaBiomarkers 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.
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
Uveal MelanomaThis is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.
Phase I/II Study of AloCelyvir in Patients With Metastatic Uveal Melanoma
Uveal MelanomaMetastaticThis is a non-randomized, single arm, single center, phase I/II study of AloCelyvir in subjects with mUM to the liver, the main site for M1 in this disease. This study is divided into 3 phases: Screening, Treatment, and Follow-up. 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 AloCelyvir in weekly intravenous infusions at doses of 0.5x106 cells/kg for 8 weeks. After 4 first treatment doses a new tumor biopsy will be mandatory. Treatment will be maintained for 2 months (8 weeks) but can be stopped earlier if disease progression, unacceptable toxicity, or patient withdrawal. Subjects that are no longer receiving AloCelyvir will enter the Follow-up phase. Subjects that are no longer receiving AloCelyvir because of unacceptable toxicity or due to investigator judgment will undergo radiological evaluations of the tumor every 8 weeks during the first 12 months (48 weeks), and then every 12 weeks until the progression of disease (progression follow-up). Subjects that are no longer receiving Alocelyvir because of progression will enter the long term OS follow-up until their death or until the end of the study, whatever happens before. Subjects who have switched to an alternative treatment without disease progression will receive a formal follow-up with images tests until progression, and after progression long term follow up to record the date of death.
A Prospective Natural History Study in Uveal Melanoma
Uveal MelanomaThe 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.
Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)
Uveal MelanomaThe study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM. Supportive care in patients with metastatic Uveal Melanoma (UM)
Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma
Uveal MelanomaThe objectives of the study are the morpho-phenotypic evaluation of uveal melanoma and to identify molecular prognostic factors that may be correlated with disease severity, tumour progression and response to treatment. These objectives will be achieved through immunohistochemical and genetic analyses.
The Role of Genetic Mutations and of Circulating mRNAs in Uveal Melanoma
Uveal MelanomaThe aim of the study is to identify genetic and epigenetic biomarkers in uveal melanoma, and to evaluate their diagnostic and prognostic role. In particular, the specific objectives are: to identify the circulating somatic mutations associated with uveal melanoma; to identify the de-regulated miRNAs associated with uveal melanoma; to evaluate the diagnostic and prognostic role of the identified genetic and epigenetic markers; to identify possible therapeutic targets.
Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma...
Uveal MelanomaUveal melanoma is the most common primary intraocular tumor in adults. The local treatment is effective, but patients still die of metastatic disease. It has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients. Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma. The investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. Detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.