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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

Locations
Other Locations
Australia
Alfred Hospital
NOT_YET_RECRUITING
Melbourne
St Vincents Hospital
RECRUITING
Sydney
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 8
Treatments
Experimental: Combination
Tebentafusp/ Roginolisib
Related Therapeutic Areas
Sponsors
Leads: St Vincent's Hospital, Sydney

This content was sourced from clinicaltrials.gov

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