NCT07203391
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
Recruiting · Phase 1 · St Vincent's Hospital, Sydney · registry updated 2026-04-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
Inclusion
- Male or female participants must be aged 18 years or over at the time, to be eligible to participate in this study.
- Histologically or cytologically confirmed metastatic UM or unresectable UM patients
- HLA-A\*02:01 positive
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Currently undergoing first-line treatment for mUM with tebentafusp
- Tebentafusp related toxicity, including cytokine release syndrome that has resolved to grade ≤ 1 as per CTCAE v5.0.
Exclusion
- Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:
- Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and/or radiation).
- Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry
- Ongoing Grade 2 or greater treatment related toxicity due to tebentafusp
- Prior treatment with a PI3Kδ inhibitor
- Prior Grade 4 cytokine release syndrome related to Tebentafusp