RecruitingPhase 1

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

Australia8 participantsStarted 2026-02-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

Exclusion criteria

✕. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:
✕. 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
✕. Prior Grade 4 cytokine release syndrome related to Tebentafusp
✕. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions:
✕. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent.

What they're measuring

• To determine the safety and tolerability of roginolisib and tebentafusp in HLA-A*02:01 positive patients advanced uveal melanoma (UM).

Timeframe: Through study completion, estimated average of 1 year

• 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).

Timeframe: Through study completion, estimated average of 1 year

Trial details

NCT IDNCT07203391

SponsorSt Vincent's Hospital, Sydney

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Uveal Melanoma, Metastatic trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

Exclusion criteria

✕. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:
✕. 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
✕. Prior Grade 4 cytokine release syndrome related to Tebentafusp
✕. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions:
✕. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent.

What they're measuring

• To determine the safety and tolerability of roginolisib and tebentafusp in HLA-A*02:01 positive patients advanced uveal melanoma (UM).

Timeframe: Through study completion, estimated average of 1 year

• 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).

Timeframe: Through study completion, estimated average of 1 year