OncoMatch/Clinical Trials/NCT07203391
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
Is NCT07203391 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies roginolisib for uveal melanoma, metastatic.
Treatment: roginolisib — This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
Check if I qualifyExtracted eligibility criteria
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.
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