Study on Darovasertib and Crizotinib for Treating Non-Metastatic Uveal Melanoma

Sponsor: IDEAYA Biosciences

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Honor Health Research Institute85258ScottsdaleArizona
UCLA Medical Center90024Los AngelesCalifornia
Dana Farber Cancer Institute02215BostonMassachusetts
Cancer Hematology Centers Western Michigan49503Grand RapidsMichigan
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Northwell Health10075New YorkNew York
Duke Cancer Center27710RaleighNorth Carolina
Cleveland Clinic44195ClevelandOhio
Wills Eye Hospital at Thomas Jefferson University19107PhiladelphiaPennsylvania
Sarah Cannon Research Institute (SCRI)37203NashvilleTennessee

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