CM-PRO Study_v1
Research type
Research Study
Full title
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
IRAS ID
363133
Contact name
Mandeep Singh Sagoo
Contact email
Sponsor organisation
Aura Biosciences Limited
Duration of Study in the UK
2 years, 4 months, 14 days
Research summary
Choroidal melanoma is a rare type of eye cancer that starts in the layer of the eye called the choroid. It is the most common eye cancer in adults. Many factors can affect someone’s outlook, such as their age, the size of the tumour, and what the cells look like under a microscope. Unfortunately, around half of people with choroidal melanoma may go on to develop cancer in other parts of the body.
Belzupacap sarotalocan (also called bel‑sar) is a new type of treatment being developed by Aura Biosciences. It is designed to treat early‑stage choroidal melanoma, including very small or indeterminate tumours that may be difficult to diagnose or treat with current methods. Earlier research (in a Phase 2 study) showed that giving bel‑sar into the space just above the choroid helped deliver the drug directly to the tumour. In that study, many people who responded to treatment had their tumour stop growing, kept good vision, and experienced acceptable side effects.
Based on these results, Aura is now running a large global Phase 3 clinical trial called CoMpass, which is testing how well bel‑sar works and how safe it is for people with early choroidal melanoma.
This patient‑reported outcome (PRO) study runs alongside the CoMpass trial. Its purpose is to understand how people feel and function during their treatment. For example, how symptoms affect daily life, how well they can carry out everyday activities, and how their overall quality of life is impacted. By collecting this information directly from patients, this study will help provide a more complete picture of how treatment affects people beyond the medical tests and scans.
REC name
West of Scotland REC 5
REC reference
26/WS/0024
Date of REC Opinion
16 Feb 2026
REC opinion
Further Information Favourable Opinion