Darovasertib for Eye Cancer

Recruiting at 75 trial locations

Overseen By Mwe Mwe Chao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: IDEAYA Biosciences

Disqualifiers: Metastatic UM, Previous UM treatment, Others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by treatment type

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called darovasertib for individuals with uveal melanoma, a type of eye cancer. The goal is to determine if darovasertib, when used before standard treatments like radiation or surgery, improves outcomes. Participants will either receive standard treatment immediately or try darovasertib first. Those with uveal melanoma that hasn't spread and who haven't yet received treatment may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that darovasertib is likely to be safe for humans?

Research has shown that darovasertib has promising safety results in earlier studies with patients who have uveal melanoma, a type of eye cancer. One study found that 83% of patients experienced some shrinkage in their eye tumors, with over half seeing a significant reduction. Importantly, most patients retained their eyes, suggesting the treatment is generally well-tolerated.

Although detailed safety data from these studies are not provided, the testing of darovasertib in a later-phase trial indicates that earlier tests demonstrated it to be reasonably safe for humans. This is a positive sign for those considering joining the trial, as it means the treatment has passed initial safety checks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for eye cancer, such as surgery, radiation, or chemotherapy, Darovasertib offers a novel approach by specifically targeting the molecular pathways involved in the growth of cancer cells. This targeted therapy works by inhibiting certain proteins that promote tumor growth, potentially leading to more effective and less toxic outcomes. Researchers are excited about Darovasertib because it could provide a more precise treatment with fewer side effects, offering new hope for patients with eye cancer.

What evidence suggests that darovasertib might be an effective treatment for eye cancer?

Previous studies have shown promising results for darovasertib in treating uveal melanoma, a type of eye cancer. About 83% of patients experienced a reduction in their eye tumors, with over half seeing tumors shrink by 20% or more. This treatment also preserved the eyes in 57% of patients who might have otherwise needed removal. Additionally, darovasertib improved vision in 65% of patients. In this trial, participants in the treatment arm will receive darovasertib followed by definitive primary local therapy. These findings suggest that darovasertib could effectively reduce tumors and improve eye health for people with this condition. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with primary non-metastatic uveal melanoma, which is a type of eye cancer. Participants should be in good physical condition (ECOG 0 or 1), have their major organs functioning well, and must agree to follow the study's procedures after giving informed consent.

Inclusion Criteria

Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements

My cancer is uveal melanoma and has not spread.

I am fully active or can carry out light work.

Exclusion Criteria

I have had treatment for uveal melanoma.

My cancer has spread from the original site.

I need my eye removed regardless of treatment outcomes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant darovasertib followed by definitive primary local therapy (e.g., plaque brachytherapy, proton beam radiation, or enucleation)

Varies by treatment type

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on vision and tumor recurrence

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Darovasertib

Trial Overview The study tests darovasertib as a neoadjuvant treatment, meaning it's given before the main treatment for eye cancer. It's a Phase 3 trial where patients are randomly assigned to receive darovasertib or another therapy before surgery or radiation.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)

Group II: Control Arm Active Control 1 Intervention

Immediate Primary Local therapy

Who Is Running the Clinical Trial?

IDEAYA Biosciences

Lead Sponsor

Trials

6

Recruited

1,300+

Citations

1. ir.ideayabio.com ir.ideayabio.com/2025-09-08-IDEAYA-Biosciences-Announces-Positive-Interim-Phase-2-Data-for-Darovasertib-in-the-Neoadjuvant-Setting-of-Primary-Uveal-Melanoma

News Releases Treatment with darovasertib resulted in robust ocular tumor shrinkage, lower simulated radiation doses to the eye and meaningful visual ...

2. prnewswire.com prnewswire.com/news-releases/ideaya-biosciences-announces-positive-phase-2-data-for-darovasertib-in-the-neoadjuvant-setting-of-primary-uveal-melanoma-in-a-proffered-paper-oral-presentation-at-esmo-2025-302588310.html

IDEAYA Biosciences Announces Positive Phase 2 Data for ... 83% (78/94) of patients demonstrated ocular tumor shrinkage, with 54% (51/94) achieving ≥20% tumor shrinkage · 57% (24/42) eye preservation rate ...

3. onclive.com onclive.com/view/neoadjuvant-darovasertib-produces-preliminary-responses-in-uveal-melanoma

Neoadjuvant Darovasertib Produces Preliminary ... Darovasertib demonstrated significant ocular tumor shrinkage and reduced radiation dose in uveal melanoma patients, improving visual outcomes.

4. firstwordpharma.com firstwordpharma.com/story/6327486

ESMO25: IDEAYA's darovasertib impresses in twin ocular ... Ocular tumours shrank in 83% of patients, with over half (54%) seeing reductions of 20% or more. Among those initially slated for eye removal, ...

5. targetedonc.com targetedonc.com/view/darovasertib-delivers-promising-antitumor-activity-in-uveal-melanoma

Darovasertib Delivers Promising Antitumor Activity in ... The efficacy results also showed that darovasertib was associated with at least some visual improvement in 65% of patients. Using a vision tool, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05907954

NCT05907954 | (Neo)Adjuvant IDE196 (Darovasertib) in ... Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10419210/

Darovasertib, a novel treatment for metastatic uveal ... Based on the efficacy and safety data, a multi-center, open-label phase I/II trial will be conducted to determine the efficacy and safety of ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.9510

A phase 2 safety and efficacy study of neoadjuvant ... The results suggest that PKC inhibition with darovasertib can induce clinically meaningful tumor shrinkage in patients with primary UM patients who otherwise ...