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Darovasertib for Ocular Melanoma

Phase 2
Recruiting
Research Sponsored by IDEAYA Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to dose orally
ECOG Performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose to end of follow-up, approximately 44 months
Awards & highlights

Study Summary

This trial tested a drug to treat uveal melanoma in its early stages.

Who is the study for?
This trial is for individuals with primary localized uveal melanoma who need enucleation or plaque brachytherapy. Participants should be in good physical condition (ECOG 0-1), not have other serious eye diseases, and must not be pregnant or nursing. They should agree to use birth control, be able to take oral medication, and have proper organ function. Those with concurrent cancer, significant heart issues, malabsorption disorders, active HIV/Hep B/C infections or previous PKC inhibitor treatments are excluded.Check my eligibility
What is being tested?
The trial is testing Darovasertib (IDE196) as a new treatment option for patients with localized ocular melanoma. It's given before (neoadjuvant) and after (adjuvant) standard procedures like enucleation or plaque brachytherapy to see if it can improve outcomes.See study design
What are the potential side effects?
Potential side effects of Darovasertib may include but are not limited to nausea, fatigue, skin rash, changes in liver enzymes indicating liver stress, vision disturbances due to the drug's effect on the eyes being treated for melanoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take medicine by mouth.
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I am fully active or can carry out light work.
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I do not have any major eye diseases.
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I need eye surgery or radiation for my eye melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose to end of follow-up, approximately 44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose to end of follow-up, approximately 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
Secondary outcome measures
Assessment of visual acuity loss
Evaluate tumor response to neoadjuvant IDE196
Rate of local disease recurrence
+1 more
Other outcome measures
Overall survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: darovasertibExperimental Treatment1 Intervention
IDE196 (darovasertib) oral open label

Find a Location

Who is running the clinical trial?

IDEAYA BiosciencesLead Sponsor
4 Previous Clinical Trials
856 Total Patients Enrolled
Matthew Maurer, MDStudy DirectorIDEAYA Biosciences
3 Previous Clinical Trials
706 Total Patients Enrolled
Jasgit Sachdev, MDStudy DirectorIDEAYA Biosciences
3 Previous Clinical Trials
433 Total Patients Enrolled

Media Library

darovasertib Clinical Trial Eligibility Overview. Trial Name: NCT05907954 — Phase 2
Uveal Melanoma Research Study Groups: darovasertib
Uveal Melanoma Clinical Trial 2023: darovasertib Highlights & Side Effects. Trial Name: NCT05907954 — Phase 2
darovasertib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05907954 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total sample size of participants in this investigation?

"Confirmed. According to the information on clinicaltrials.gov, this medical trial is presently enrolling participants. The study was initially published on June 1st 2023 and has since been updated as of June 14th 2023; 82 patients are required for just one site."

Answered by AI

Has darovasertib been ratified by the FDA?

"Based on our team's assessment, darovasertib is rated a 2 due to its Phase 2 trial status. This denotes that there are data points confirming safety but efficacy has yet to be confirmed."

Answered by AI

What goals has this trial articulated for its completion?

"This 12-month study will measure Cohort 1 (enucleation) and the number of patients that convert to radiation, as well as best corrected visual acuity loss, local disease recurrence rate, and metastatic disease rate."

Answered by AI

Is there room for additional participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this study - which was established on June 1st 2023 - is currently seeking volunteers. The research demands 82 participants from a single location."

Answered by AI

Who else is applying?

What site did they apply to?
Sarah Cannon Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am exploring adjuvant therapy for uveal melanoma. My oncologist suggested the possibility of a clinical trial and mentioned Sarah Cannon.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
2023. "(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05907954.
~55 spots leftby Jan 2026
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