Clinical trial for Uveal Melanoma, Metastatic
Official title Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
ClinicalTrials.gov ID: NCT07203391
What this study is testing
What is roginolisib?
roginolisib is an investigational medicine, being studied as a potential treatment for uveal melanoma, metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with...
- 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
See the full eligibility criteria
Who can 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.
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.