RecruitingPhase 1NCT07203391
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
TRIUMPH - Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
Sponsor
St Vincent's Hospital, Sydney
Enrollment
8 participants
Start Date
Feb 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing whether adding a drug called roginolisib to an existing cancer immunotherapy (tebentafusp) can help improve outcomes for people with metastatic uveal melanoma — a rare eye cancer that has spread. The combination is designed to help the immune system stay active and keep fighting the cancer longer.
**You may be eligible if...**
- You are 18 or older with metastatic or inoperable uveal melanoma
- You carry a specific immune marker called HLA-A*02:01 (a blood test can determine this)
- You are currently receiving tebentafusp as your first-line treatment
- Any side effects from tebentafusp have resolved to mild or no symptoms
- Your overall health and ability to function is rated good (ECOG 0 or 1)
- You are willing to use highly effective contraception during and for 6 months after treatment
**You may NOT be eligible if...**
- You have untreated or symptomatic brain metastases
- You have significant heart, liver, or immune-related health conditions
- You are pregnant or breastfeeding
- You have previously received certain immunosuppressive treatments
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGroginolisib
Investigational combination - initially at 40mg (Dose 1) then 80mg (Dose 2)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07203391
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