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.
Treatment: roginolisib — This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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 qualifyRelated pages