Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis (NCT07203391) is a Phase 1 interventional studying Uveal Melanoma, Metastatic, sponsored by St Vincent's Hospital, Sydney. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Uveal Melanoma, Metastatic, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 8 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female participants must be aged 18 years or over at the time, to be eligible to participate in this study. 2. diagnosed by tissue sample (biopsy-confirmed) metastatic UM or unresectable UM patients 3. HLA-A\*02:01 positive 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. Currently undergoing first-line treatment for mUM with tebentafusp 6. Tebentafusp related toxicity, including cytokine release syndrome that has resolved to grade ≤ 1 as per CTCAE v5.0. 7. 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. 8. Pregnant or lactating women are prohibited from enrolling on this program. 9. Male participants are not allowed to donate sperm from the time of enrolment until 6 months post- administration of program interventions. Who Should NOT Join This Trial: 1. 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: 1. Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and/or radiation). 2. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry 2. Ongoing Grade 2 or greater treatment related toxicity due to tebentafusp 3. Prior treatment with a PI3Kδ inhibitor 4. Prior Grade 4 cytokine release syndrome related to Tebentafusp 5. 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male or female participants must be aged 18 years or over at the time, to be eligible to participate in this study. 2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients 3. HLA-A\*02:01 positive 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. Currently undergoing first-line treatment for mUM with tebentafusp 6. Tebentafusp related toxicity, including cytokine release syndrome that has resolved to grade ≤ 1 as per CTCAE v5.0. 7. 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. 8. Pregnant or lactating women are prohibited from enrolling on this program. 9. Male participants are not allowed to donate sperm from the time of enrolment until 6 months post- administration of program interventions. Exclusion Criteria: 1. 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: 1. Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and/or radiation). 2. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry 2. Ongoing Grade 2 or greater treatment related toxicity due to tebentafusp 3. Prior treatment with a PI3Kδ inhibitor 4. Prior Grade 4 cytokine release syndrome related to Tebentafusp 5. 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: 1. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent. 2. Local or topical steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable. 3. Premedication for allergy to contrast reagent. 6. 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. 7. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications. 8. 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. 9. Known HIV infection unless all of the following are applicable: 1. Receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥3 months prior to the planned first study intervention 2. CD4 T-cell count \>350 cells/µl 3. CD4 T-cell nadir (lowest historical count) \< 350 cells/µl 4. Viral load confirmed as \<50 copies/ml during Screening. 10. 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. 11. Known HCV infection, unless the participant has received curative treatment, and viral load was confirmed as undetectable during Screening. 12. 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. 1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 30 mL/minute. 2. 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. 3. Alanine aminotransferase \> 5 × ULN in the presence of liver metastases; \> 3 X ULN if not 4. Aspartate aminotransferase \> 5 × ULN in the presence of liver metastases ; \> 3 X ULN if not 5. Platelet count \< 75 × 109/L 6. Hemoglobin \< 9 g/dL 13. Clinically significant cardiac disease or impaired cardiac function, including any of the following: 1. Congestive heart failure (New York Heart Association Class ≥ 3) 2. QTcF\>470msec at baseline 3. Uncontrolled hypertension defined as systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 110 mmHg with the following requirements: 4. 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. 5. Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart. 6. Acute myocardial infarction or unstable angina pectoris \< 6 months prior to the planned first dose of program intervention.

Treatments Being Tested

DRUG

roginolisib

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

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St Vincents Hospital
Sydney, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07203391), the sponsor (St Vincent's Hospital, Sydney), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07203391 clinical trial studying?

This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07203391?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07203391?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07203391. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07203391. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.