Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
RATIONALE: Interferon beta may interfere with the growth of tumor cells. PURPOSE: This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.
NCT00085306 — Stage IV Melanoma
Status: Completed
http://inclinicaltrials.com/stage-iv-melanoma/NCT00085306/
Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*0201 Positive Patients With High-risk Non-metastatic Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)
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.
NCT06246149 — Uveal Melanoma
Status: Not yet recruiting
http://inclinicaltrials.com/uveal-melanoma/NCT06246149/
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
NCT05907954 — Uveal Melanoma
Status: Recruiting
http://inclinicaltrials.com/uveal-melanoma/NCT05907954/
Melphalan Intra-arterial Chemotherapy for Choroidal Melanoma Chemoreduction - a Phase I Clinical Trial
The goal of this clinical trial is to investigate a new approach for treating large uveal melanomas, a type of eye cancer. The study aims to determine the effectiveness of using intra-arterial melphalan, a chemotherapy drug, to reduce tumor thickness, allowing for subsequent radiation therapy using a Ru-106 plaque. The main questions this trial seeks to answer are: - Can intra-arterial melphalan effectively reduce the thickness of large uveal melanomas? - Is the combination of intra-arterial melphalan and brachytherapy a safe and effective treatment option for these tumors? Participants enrolled in the trial have clinically diagnosed choroidal melanoma with tumor thickness equal to or greater than 8.00 mm. They will undergo a procedure where the chemotherapy drug is injected directly into the blood vessels that supply the tumor. After a few weeks, they will receive the radiation treatment using a small device placed on the eye. Throughout the trial, participants will have different tests to monitor the tumor and their vision, such as ultrasound scans, pictures of the inside of the eye, and a test called electroretinography (ERG) to check the function of the retina. These tests will be done at the start of the trial and at 1, 3, and 6 months later to track the progress of the treatment.
NCT05893654 — Uveal Melanoma
Status: Enrolling by invitation
http://inclinicaltrials.com/uveal-melanoma/NCT05893654/
Neoadjuvant/Adjuvant Trial of Darovasertib in Ocular Melanoma
The purpose of this study is to determine the feasibility and tolerability of neo-adjuvant/adjuvant Darovasertib on uveal melanoma patients. Who is it for? Patients may be eligible to join this study with high-risk uveal melanoma and planned to undergo enucleation Study details: Eligible patients will undergo up to 4 weeks of treatment with Darovasertib (300mg, twice a day as a starting dose) and once determiend safe then up to 6 months after fulfilling inclusion/exclusion criteria and consent. Select patients will undergo adjuvant treatment for 6 months based on their initial response. It is hoped that this research will provide insight into the safety and tolerability of Darovasertib. Furthermore, it aims to document the pharmacodynamic and pharmacokinectic effects of Darovasertib on uveal melanoma patients.
NCT05187884 — Ocular Melanoma
Status: Active, not recruiting
http://inclinicaltrials.com/ocular-melanoma/NCT05187884/
Phase II Single-arm Multi-center Study of Adjuvant Ipilimumab in Combination With Nivolumab in Subjects With High-risk Ocular Melanoma
This is an open-label, multi-site, single-arm Phase 2 study of adjuvant nivolumab combined with ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma, as defined in eligibility criteria, without evidence of metastatic disease. All patients enrolled to the study will be treated with nivolumab 240 mg IV every 2 weeks plus ipilimumab 1mg/kg IV every 6 weeks. 1 cycle = 6 weeks. Treatment will continue until disease progression, unacceptable toxicity, patient request to discontinue or completion of treatment. Subjects may receive up to 25 doses of nivolumab and 8 doses of ipilimumab
NCT03528408 — Melanoma
Status: Active, not recruiting
http://inclinicaltrials.com/melanoma/NCT03528408/
A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma
This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment.
NCT02678572 — Melanoma, Ocular
Status: Completed
http://inclinicaltrials.com/melanoma-ocular/NCT02678572/
Sorafenib and Radioembolization With Sir-Spheres® for the Treatment of Metastatic Ocular Melanoma
The best way to combine a loco-regional procedure such as chemoembolisation or radioembolization combined with an anti-angiogenic drug is not clear. This phase I trial aims to establish, first, the tolerability of the combination of liver radioembolization with SirSpheres® and sorafenib in uveal melanoma patients with liver metastasis studying different schedules of administration of sorafenib after and before radioembolization. Secondly, we aim to evaluate angiogenic markers modifications during these different schedules, either in the serum or radiologicaly. Dose of Sorafenib will be 400 mg BID and the timing of introduction will differ for one cohort to the other, given after the radioembolization for initials cohorts and finally, before and concomitantly to radioembolization for the last cohort.
NCT01893099 — Ocular Melanoma
Status: Completed
http://inclinicaltrials.com/ocular-melanoma/NCT01893099/
Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.
NCT01835145 — Stage IV Uveal Melanoma AJCC v7
Status: Completed
http://inclinicaltrials.com/stage-iv-uveal-melanoma-ajcc-v7/NCT01835145/
Phase II Study in Patients With Metastatic Ocular Melanoma Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Autologous Tumor-Infiltrating Lymphocytes With or Without High Dose Aldesleukin
Background: - The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. This study will use chemotherapy to prepare the immune system before this white blood cell treatment. After receiving the cells, the drug aldesleukin (IL-2) may be given to help the cells stay alive longer. Objectives: - To see if chemotherapy and white blood cell therapy is a safe and effective treatment for advanced ocular melanoma. Eligibility: - Individuals at least greater than or equal to 16 years to less than or equal to 75 years who have advanced ocular melanoma. Design: - Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. - Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. - Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. - Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.
NCT01814046 — Metastatic Uveal Melanoma
Status: Terminated
http://inclinicaltrials.com/metastatic-uveal-melanoma/NCT01814046/