Study on IDE196 (Darovasertib) Treatment Before and After Surgery for Localized Eye Melanoma
Sponsor: IDEAYA Biosciences
ClinicalTrials ID:NCT05907954
This clinical trial is testing the use of the drug IDE196 (Darovasertib) before and after surgery or radiation therapy in patients with localized eye melanoma, specifically uveal melanoma. The study aims to evaluate the drug's effectiveness in preventing cancer recurrence and spread.
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Program Overview
The study is investigating the use of IDE196 (Darovasertib) in patients with primary uveal melanoma, a type of eye cancer. The treatment is given before surgery or radiation therapy to shrink the tumor and possibly after to prevent the cancer from coming back or spreading. The trial will follow patients for up to three years to monitor their vision, check for cancer recurrence, and see if the cancer spreads to other parts of the body.
Description
This Phase 2 study involves multiple centers and is open-label, meaning both the researchers and participants know what treatment is being given. Patients with primary uveal melanoma, which is a type of eye cancer, will receive IDE196 (Darovasertib) before their main treatment, which could be surgery to remove the eye (enucleation) or radiation therapy (plaque brachytherapy). This initial treatment phase can last up to six months or until the maximum benefit is achieved. After the main treatment, patients may continue to receive IDE196 for another six months to help prevent the cancer from returning or spreading. The study will include long-term follow-up for up to three years to assess the impact on vision, check for any return of the cancer, and monitor for the development of metastatic disease, which is when cancer spreads to other parts of the body.
Eligibility Criteria
Inclusion Criteria
- Have primary localized uveal melanoma that requires surgery or radiation therapy.
- Be able to take medication by mouth.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have no other significant eye diseases.
- Have adequate organ function as determined by medical tests.
- Not be pregnant, nursing, or planning to become pregnant, and agree to use birth control during the study.
Exclusion Criteria
- Have previously been treated with a Protein Kinase C (PKC) inhibitor.
- Have another active cancer.
- Have an active HIV infection or hepatitis B or C.
- Have a disorder that affects the absorption of medication.
- Be unable to stop taking certain prohibited medications.
- Have impaired heart function or significant heart disease.
- Have any other condition that might interfere with the study results or interpretation.
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