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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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

  • Alfred Hospital

    Melbourne, Victoria

    Mark Shackleton, MBBS PhD

    Not yet recruiting

  • St Vincents Hospital

    Sydney, New South Wales, 2010

    Robert Kent, 61293555611, svhs.cancerresearch@svha.org.au

    Recruiting

Other trials in Australia

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

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 groups in NCT07203391
Study groupRoleWhat they receive
CombinationExperimentalTebentafusp/ Roginolisib
Receives: Drug: roginolisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • 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

  2. • 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.

  1. First posted2 Oct 2025
  2. Study start1 Feb 2026
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing roginolisib in people with Uveal Melanoma, Metastatic, run by St Vincent's Hospital, Sydney at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• To determine the safety and tolerability of roginolisib and tebentafusp in HLA-A*02:01 positive patients advanced uveal melanoma (UM). (time frame: Through study completion, estimated average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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