(Neo)adjuvant IDE196 (darovasertib) in patients with localised ocular melanoma
Research type
Research Study
Full title
(Neo)adjuvant IDE196 (darovasertib) in patients with localised ocular melanoma
IRAS ID
1008546
Contact name
Lillian Chu
Contact email
Sponsor organisation
Ideaya Biosciences, Inc
Eudract number
2023-506683-14
Clinicaltrials.gov Identifier
Research summary
Patients with large, localized uveal melanomas (a cancer in the middle of the eye wall) currently are treated with either removal of the eyeball(enucleation) or radiation directed at the tumor to kill or shrink it. In uveal melanoma, targeted radiation therapy (brachytherapy) is commonly used, where small radioactive beads are targeted to the eye for a few days using a plaque implant. Enucleation and radiation therapy often result in loss of useful vision.New treatments are needed to help reduce the frequency and severity of this vision loss.
IDE196 (also known as darovasertib) has been shown to shrink uveal melanoma tumors in clinical trial patients who have cancer only in the eye and/or cancer that has spread outside the eye (metastatic cancer). For patients with cancer in the eye, IDE196 treatment
improved the visual symptoms associated with the melanoma. Based on clinical trial results, it is thought that treatment with IDE196 may help to avoid the need to remove the eye and/or decrease the amount of radiation given during brachytherapy. Hence, the eye
may be preserved and/or useful vision improved.By reducing the amount of local therapy given directly into the tumor, this may also improve any potential symptoms, side effects, and treatment complications of current therapies.
This clinical trial will test the effect of IDE196 treatment before (as neoadjuvant therapy) and after (as adjuvant therapy) the planned enucleation or radiation therapy. The adjuvant therapy with IDE196 may serve to kill any tumor that might be left after the previous treatment.
Previous studies of IDE196 showed that a dose of 300 mg taken twice daily was tolerable and safe profile for uveal melanoma patients.REC name
North East - York Research Ethics Committee
REC reference
23/NE/0190
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion