Study on Darovasertib and Crizotinib for Treating Non-Metastatic Uveal Melanoma
Sponsor: IDEAYA Biosciences
ClinicalTrials ID:NCT07804186
This clinical trial is testing whether the combination of darovasertib and crizotinib can help prevent the return of uveal melanoma, a type of eye cancer, in patients who have already received initial treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if adding the drugs darovasertib and crizotinib after initial treatment can help prevent uveal melanoma from coming back in patients who are at high risk. Participants will either receive the drug combination or be monitored without it to compare outcomes over five years.
Description
This study involves patients with uveal melanoma, a type of eye cancer, who have already completed their initial treatment, such as surgery or radiation, and currently show no signs of cancer spread. Participants will be divided into two groups: one group will receive the drugs darovasertib and crizotinib, while the other group will be observed without additional treatment. The goal is to see if the drug combination can help prevent the cancer from returning. Both groups will be monitored for up to five years to assess long-term outcomes like cancer recurrence and survival rates.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with primary uveal melanoma at high risk of coming back (Stage II or III).
- Completed initial treatment like surgery or radiation.
- In good general health with an ECOG performance status of 0 or 1.
- Have good organ function.
- Aged 18 or older.
- Able to understand and sign a consent form.
- Completed initial treatment within 120 days before starting the study.
- Agree to use contraception if applicable.
Exclusion Criteria
- Have had previous systemic treatment for uveal melanoma.
- Show signs of cancer spread.
- Have another active cancer, except for certain skin cancers or other non-threatening cancers.
- Have AIDS-related illness.
- Have lung diseases like interstitial lung disease or pneumonitis.
- Have a history of fainting, which will be reviewed individually.
- Have active hepatitis B or C.
- Have digestive issues that affect medication absorption.
- Are pregnant or breastfeeding.
- Have heart problems.
- Had a stroke in the last 6 months.
- Are taking medications that interfere with the study drugs.
- Have allergies to certain meat products or gelatin.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Honor Health Research Institute | 85258 | Scottsdale | Arizona |
| UCLA Medical Center | 90024 | Los Angeles | California |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Cancer Hematology Centers Western Michigan | 49503 | Grand Rapids | Michigan |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Northwell Health | 10075 | New York | New York |
| Duke Cancer Center | 27710 | Raleigh | North Carolina |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| Wills Eye Hospital at Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
| Sarah Cannon Research Institute (SCRI) | 37203 | Nashville | Tennessee |
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