Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A biopsy is required to confirm the diagnosis of advanced or metastatic ocular/uveal melanoma.

Participants are randomly assigned to receive either roginolisib or a treatment chosen by the investigator.

The choice of treatment is based on the participant’s previous medical treatments and current health status.

If assigned to roginolisib, the medication is taken orally. The dosage and frequency are determined by the study protocol.

If assigned to the investigator’s choice, medications such as dacarbazine, nivolumab, pembrolizumab, or ipilimumab are administered through intravenous infusion. The specific medication and dosage depend on the participant’s treatment plan.

Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

This includes physical examinations, blood tests, and imaging studies to evaluate the response to treatment.

A follow-up biopsy is conducted at a specified point in the study to assess the tumor’s response to treatment.

Imaging studies are performed periodically to measure the size of the tumor and to detect any changes.

The treatment phase continues until the study’s end date or until the participant’s condition changes.

Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

After the treatment phase, participants enter a follow-up period to monitor long-term effects and overall survival.

Regular check-ups are scheduled to ensure ongoing health and to address any late-emerging side effects.