Actively Recruiting
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
Led by St Vincent's Hospital, Sydney · Updated on 2026-04-23
8
Participants Needed
2
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
CONDITIONS
Official Title
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically or cytologically confirmed metastatic or unresectable uveal melanoma
- Positive for HLA-A*02:01
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Currently receiving first-line treatment with Tebentafusp
- Tebentafusp-related toxicity, including cytokine release syndrome, resolved to grade 1 or lower per CTCAE v5.0
- Participants of childbearing potential who are sexually active with non-sterilized partners agree to use highly effective contraception from screening until 6 months after last dose
- Pregnant or lactating women are not eligible
- Male participants agree not to donate sperm from enrollment until 6 months after last dose
You will not qualify if you...
- Untreated or symptomatic central nervous system metastases, leptomeningeal disease, or spinal cord compression
- Treated CNS lesions must be stable for at least 4 weeks and participant neurologically stable without systemic corticosteroids for at least 2 weeks
- Ongoing grade 2 or higher treatment-related toxicity from Tebentafusp
- Prior treatment with a PI3K delta inhibitor
- Prior grade 4 cytokine release syndrome from Tebentafusp
- Systemic steroid or immunosuppressive drug use within 2 weeks before first dose, except limited adrenal insufficiency treatment, local/topical steroids, or allergy premedication
- Any medical condition preventing safe participation or compliance
- Inability to swallow or conditions preventing oral medication intake
- Chronic viral infections unless controlled and stable per specified criteria for HIV, HBV, and HCV
- Abnormal screening lab values including low creatinine clearance, elevated bilirubin, elevated liver enzymes, low platelet count, or low hemoglobin
- Significant cardiac disease including severe heart failure, prolonged QT interval, uncontrolled hypertension, recent heart attack, or unstable angina
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
St Vincents Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
2
Alfred Hospital
Melbourne, Victoria, Australia
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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