Uveal Melanoma, MetastaticPhase 1TRIUMPHNCT07203391
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
A Phase 1 study testing roginolisib in people with Uveal Melanoma, Metastatic, run by St Vincent's Hospital, Sydney at 2 sites in Australia.
Trial summary
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Metastatic
- What is being tested?
- roginolisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Feb 2026to 1 Dec 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
- CD4 T-cell count >350 cells/µl
- CD4 T-cell nadir (lowest historical count) < 350 cells/µl
- Viral load confirmed as <50 copies/ml during Screening.
- Known HBV infection, unless on stable anti-viral therapy for > 4 weeks prior to the planned first dose of program intervention and viral load confirmed as undetectable during Screening.
- Known HCV infection, unless the participant has received curative treatment, and viral load was confirmed as undetectable during Screening.
- Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor.
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 30 mL/minute.
- Total bilirubin > 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN.
- Alanine aminotransferase > 5 × ULN in the presence of liver metastases; > 3 X ULN if not
- Aspartate aminotransferase > 5 × ULN in the presence of liver metastases ; > 3 X ULN if not
- Platelet count < 75 × 109/L
- Hemoglobin < 9 g/dL
- Clinically significant cardiac disease or impaired cardiac function, including any of the following:
- Congestive heart failure (New York Heart Association Class ≥ 3)
- QTcF>470msec at baseline
- Uncontrolled hypertension defined as systolic blood pressure [BP] > 160 mmHg or diastolic BP > 110 mmHg with the following requirements:
- If initial measurement is elevated, additional assessments should be taken where each assessment is the mean value of 3 measurements taken at least 5 minutes apart.
- Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart.
- Acute myocardial infarction or unstable angina pectoris < 6 months prior to the planned first dose of program intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Not yet recruiting
Alfred Hospital
Melbourne, Victoria
Mark Shackleton, MBBS PhD
- Recruiting
St Vincents Hospital
Sydney, New South Wales, 2010
Robert Kent, 61293555611, svhs.cancerresearch@svha.org.au
About this study
Official title: TRIUMPH - Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
Read the detailed description
Based on the established activity of Tebentafusp, and the promising action of Roginolisib, this trial combines the two drugs from cycle 4 onwards in patients with metastatic uveal melanoma
- Conditions
- Uveal Melanoma, Metastatic
- Being tested
- roginolisib
- Keywords
- tebentafusp, Roginolisib
- Medical subject headings
- Uveal Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roginolisibDrug
Investigational combination - initially at 40mg (Dose 1) then 80mg (Dose 2)
| Study group | Role | What they receive |
|---|---|---|
| Combination | Experimental | Tebentafusp/ Roginolisib Receives: Drug: roginolisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine the safety and tolerability of roginolisib and tebentafusp in HLA-A*02:01 positive patients advanced uveal melanoma (UM).
CTCAE V5.0
Measured: 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
Measured: Through study completion, estimated average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Feb 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal Melanoma, MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Standard Tebentafusp with the addition of Roginlisib
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Joshua, FRACP, St Vincent's Hospital, Sydney
- Investigators
- Anthony Joshua, MBBS PhD FRACP, Principal investigator, St Vinents Hospital sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203391
- Sponsor's protocol ID
- TRIUMPH
- Acronym
- TRIUMPH
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality