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Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis (TRIUMPH)

NCT 07203391

Brief Summary

This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib.

Intervention / Treatment 

  • Drug: Roginolisib.

Inclusion Criteria

  1. Male or female participants must be aged 18 years or over at the time, to be eligible to participate in this study.
  2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients
  3. HLA-A*02:01 positive
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  5. Currently undergoing first-line treatment for mUM with tebentafusp
  6. Tebentafusp related toxicity, including cytokine release syndrome that has resolved to grade ≤ 1 as per CTCAE v5.0.
  7. 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 screening date until 6 months after the final dose of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician.
  8. Pregnant or lactating women are prohibited from enrolling on this program.
  9. Male participants are not allowed to donate sperm from the time of enrolment until 6 months post- administration of program interventions.

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