Tebentafusp-tebn with Liver-Directed Therapy for Metastatic Uveal Melanoma
This study is testing a combination of treatments for metastatic uveal melanoma (a type of eye cancer that has spread to other parts of the body), specifically when it has spread to the liver. You might be eligible if you are at least 18 years old and have uveal melanoma that has spread to your liver, with at least one measurable tumor there. The study is investigating the safety and effectiveness of tebentafusp-tebn (an immunotherapy drug) combined with liver-directed therapies (treatments focused on the liver). These liver treatments include GM-CSF (Sargramostim) and BCNU (Carmustine), which are given directly into the liver artery. The researchers will look at how safe the treatments are and how well they shrink tumors or stop the cancer from growing. This study is for people who have a specific genetic marker called HLA-A*0201. The current status of this study is unclear.
- Study design
- This is a multicenter, open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 109 participants and has different parts, including a single-arm phase and a randomized phase.
- What's involved
- If you join, you will receive weekly doses of tebentafusp-tebn, with liver-directed treatments given every 4 weeks. You will have regular visits for treatment and monitoring, and the study will track your safety and how well the treatment works.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 30 days after your last treatment. The study will also track how long it takes for your disease to progress or for you to pass away, for up to 2.5 years after the last patient's last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Tebentafusp-tebn With LDT in Metastatic UM
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rino Seedor, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Part 1A: Safety lead-inFrom when the patient receives the first study treatment to 7 days (for non-serious AEs) or 30 days (for SAEs) after completion of study treatment or withdrawal from the study.
Adverse events (AEs) according to NCI CTCAE Version 5.0. Safety and tolerability data will be presented by treatment arm using the safety population. Safety data will be summarized descriptively and will not be formally analyzed. AE presentation will include incidence, severity, and relationship to study drug.
- Part 1A: EfficacyFrom when the patient receives the first study treatment to 6 months after first treatment
6-month progression-free survival rate as determined by response criteria (RECIST 1.1). Will be summarized by count and percentage along with the two-sided 90% exact confidence interval (CI).
- Part 1B: Progression-free SurvivalFrom when patient joins study until disease progression or death, up to 2.5 years after last patient's last treatment.
Defined as the time from the date of randomization until the date of objective disease progression or death by any cause. The primary Progression-free Survival (PSF) analysis will use a one-sided log-rank test, with a type I error of 0.05. In addition, PFS will be analyzed using Cox proportional hazards model and the estimated HR with 90% Confidence Interval (CI) will be reported. Kaplan-Meier curves of PFS will be presented by treatment arm along with estimated medians PFS (CIs).
- Part 2: 6-month progression-free survival rateFrom when the patient receives the first study treatment to 6 months after first treatment.
As determined by response criteria (RECIST 1.1). Defined as the proportion of patients alive and progression-free at 6 months after treatment initiation. Will be summarized by count and percentage. In addition, a two-sided 90% Confidence Interval (CI) based on the method of Koyama and Chen will be provided. This method is appropriate because it is proposed for Simon's 2-stage design, accounting for the inherent futility analysis.