This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\*02:01-positive patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
3 mg/kg ideal body weight (max 220 mg) infused via hepatic artery catheter.
20 mcg IV day 1, 30 mcg day 8, 68 mcg day 15, then weekly thereafter.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGProgression Free Survival (PFS)
PFS will be studied as time-to-event defined by the first documented disease progression or death due to any cause, whichever occurs first, from the start date of the study treatment. PFS will be determined based on tumor assessment (RECIST version 1.1 criteria).
Time frame: Up to 24 months
Objective Response Rate (ORR)
ORR defined as the percentage of patients achieving a confirmed complete or partial response, as defined by RECIST version 1.1 criteria.
Time frame: Up to 24 months
Clinical Benefit Rate (CBR)
CBR defined as the percentage of patients achieving confirmed SD at 26 weeks, OR any confirmed CR or PR. As defined by RECIST version 1.1 criteria.
Time frame: Up to 24 months
Hepatic PFS (hPFS)
hPFS is defined as the time-to-event defined by the first documented disease progression in the liver or death due to any cause, whichever occurs first, from the start date of the study treatment. hPFS will be determined based on tumor assessment (RECIST version 1.1 criteria).
Time frame: Up to 24 months
Overall Survival (OS)
OS is calculated as the time-to-event defined by death due to any cause from the start date of the study treatment.
Time frame: Up to 24 months
Melanoma-Specific Survival (MSS)
MSS is calculated as the time-to-event defined by death due to uveal melanoma from the start date of the study treatment.
Time frame: Up to 24 months
Time to Response (TTR)
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TTR calculated as the time-to-event defined by the first documented CR or PR from the start date of the study treatment.
Time frame: Up to 24 months
Duration of Response (DOR)
DOR calculated as the time-to-event defined by the first documented progression or death due to underlying cancer from the first document CR or PR.
Time frame: Up to 24 months