Uveal Melanoma study: Darovasertib vs Crizotinib
Official title Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT07804186
What this study is testing
What is Darovasertib?
Darovasertib is an investigational medicine, taken by mouth, being studied as a potential treatment for uveal melanoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether giving these drugs after primary treatment can prevent the cancer from coming back.
- Who it's for
- Adults who have had primary uveal melanoma that has not spread to other parts of the body.
- What's involved
- Participants will take oral darovasertib and crizotinib and attend scheduled clinic visits for monitoring and tests.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)
- Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)
- ECOG performance status of 0 or 1
- Adequate organ function
- Age 18 or older
You likely can't join if
- Previous systemic treatment for Uveal Melanoma
- Clinical or radiological evidence of metastatic UM
- Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to...
- Known AIDS related illness
- History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
- History of syncope may be exclusionary, but will be reviewed on a case-by-case basis
See the full eligibility criteria
- Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)
- Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)
- ECOG performance status of 0 or 1
- Adequate organ function
- Age 18 or older
- Written informed consent and ability to comply
- Primary local therapy completed within 120 days before C1D1/randomization.
- Contraception requirements
- Previous systemic treatment for Uveal Melanoma
- Clinical or radiological evidence of metastatic UM
- Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin...
- Known AIDS related illness
- History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
- History of syncope may be exclusionary, but will be reviewed on a case-by-case basis
- Active Hepatitis B or C infection
- Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow
- Females who are pregnant or breastfeeding
- Impaired cardiac function
- History of stroke within the last 6 months of randomization
- Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib
- allergy to mammalian meat products or gelatin
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Raleigh, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Raleigh, North Carolina, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.