Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
ConditionUveal Melanoma, Metastatic
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt Vincent's Hospital, Sydney
About this trial
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- roginolisib
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov