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

NCT07203391 | Recruiting Phase 1 DMC

• 1 other identifier: TRIUMPH
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Uveal Melanoma, Metastatic

Keywords

tebentafusp; Roginolisib

Outcome Measures

Primary Outcomes (2)

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

  CTCAE V5.0

  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).

  As determined by DSMB

  Through study completion, estimated average of 1 year

Study Arms (1)

Combination

EXPERIMENTAL

Tebentafusp/ Roginolisib

Drug: roginolisib

Interventions

roginolisib DRUG

Investigational combination - initially at 40mg (Dose 1) then 80mg (Dose 2)

Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Local or topical steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.
• Premedication for allergy to contrast reagent.
• Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.
• Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
• Chronic viral infections as indicated below. NOTE: Testing for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.
• Known HIV infection unless all of the following are applicable:
• Receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥3 months prior to the planned first study intervention

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead

Study Sites (2)

St Vincents Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Uveal Melanoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Joshua, MBBS PhD FRACP

  St Vinents Hospital sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Standard Tebentafusp with the addition of Roginlisib

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: October 2, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)