OncoMatch

OncoMatch/Clinical Trials/NCT07203391

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

Is NCT07203391 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies roginolisib for uveal melanoma, metastatic.

Phase 1RecruitingSt Vincent's Hospital, SydneyNCT07203391Data as of Jun 2026Location: Australia

Treatment: roginolisibThis is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib

Check if I qualify

Extracted eligibility criteria

Treatments studied

Other

roginolisib

Cancer type

Melanoma

Biomarker criteria

Required: HLA-A A*02:01 positive (A*02:01 positive)

HLA-A*02:01 positive

Disease stage

Required: Stage IV

Metastatic disease required

metastatic UM or unresectable UM patients

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: tebentafusp (tebentafusp) — first-line

Cannot have received: pi3kδ inhibitor

Lab requirements

Blood counts

Platelet count < 75 × 10^9/L; Hemoglobin < 9 g/dL

Kidney function

Creatinine clearance < 30 mL/minute

Liver function

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; ALT > 5 × ULN in the presence of liver metastases; > 3 × ULN if not; AST > 5 × ULN in the presence of liver metastases; > 3 × ULN if not

Cardiac function

Congestive heart failure (NYHA Class ≥ 3); QTcF > 470msec at baseline; uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 110 mmHg); acute myocardial infarction or unstable angina pectoris < 6 months prior to the planned first dose

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 < 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 × 10^9/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; Acute myocardial infarction or unstable angina pectoris < 6 months prior to the planned first dose of program intervention.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07203391 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior pi3kδ inhibitor disqualifies patients from enrollment.

Does this trial require HLA-A?

Yes, HLA-A A*02:01 positive is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify

Related pages

Melanoma trials