View clinical trials related to Uveal Neoplasms.
Filter by:This phase II trial tests how well tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal (eye) melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Tebentafusp is a drug that binds to melanoma tumor cells as well as immune cells called T-cells. This binding causes an immune response against the melanoma cells, which leads to tumor cell death. Tebentafusp has been approved for the treatment of locally advanced and unresectable uveal melanoma. Giving tebentafusp before primary treatment with surgery or radiation may help shrink the tumor, prevent the disease from spreading, or reduce the likelihood that patients will require total eye removal (called enucleation).
At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour. Observation is currently the standard of care in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall survival in patients with metastatic uveal melanoma in a randomized trial. Based on the results in the advanced setting, it is hypothesized that treatment with tebentafusp may reduce the risk of development of disease recurrence.
The goal of this prospective observational study is to learn about patient quality of life and experience and medical information needs during uveal melanoma post-treatment surveillance. Participants have previously undergone treatment for non-metastatic uveal melanoma and have integrated a oncological and / or ophthalmic surveillance protocol based on their individual genomic and / or clinical risk of recurrence. The main objectives it aims to assess are: - To evaluate the effect of satisfaction with communication with the oncologist/ophthalmologist during the oncology/ophthalmology surveillance visit 6 months after the start of surveillance (T1) on the overall level of health status/quality of life (QoL). - To explore the impact on psychosocial resources and needs such as fear of recurrence, anxiety and depression 6 months after the start of surveillance (T1) and 12 months after the start of surveillance (T2). - To document patients experience of care and communication during the first 12 months of surveillance. Participants will fill in quality of life questionnaires at two timepoints. A sub-sample will be offered to participate in qualitative research interviews. Researchers will compare data from patients at low risk of recurrence with those at high risk of recurrence to see if there are significant differences with regards to quality of life, satisfaction with care and medical information needs.
This 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.
This 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.