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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
roginolisib
DrugInvestigational combination - initially at 40mg (Dose 1) then 80mg (Dose 2)
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: CombinationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
• To determine the safety and tolerability of roginolisib and tebentafusp in HLA-A*02:01 positive patients advanced uveal melanoma (UM).
CTCAE V5.0
Time frame
Through study completion, estimated average of 1 year2
• To establish a maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of roginolisib and tebentafusp in HLA-A*02:01 positive patients advanced uveal melanoma (UM).
As determined by DSMB
Time frame
Through study completion, estimated average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov