Brief Summary
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib.
Intervention / Treatment
- Drug: Roginolisib.
Inclusion Criteria
- 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 Oncologythe study, diagnosis and treatment of cancer 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 gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells ≤ 1 as per CTCAE v5.0.
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control (eg double barrier) from the trial screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening date until 6 months after the final dosethe amount of medication taken of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician.
- Pregnant or lactating women are prohibited from enrolling on this program.
- Male participants are not allowed to donate sperm from the time of enrolment until 6 months post- administration of program interventions.