What side effects are associated with this type of intervention?

The most common treatments for Uveal Melanoma, including Protein Kinase C inhibitors like IDE196 (darovasertib), can have various side effects. These may include ocular toxicities such as blurred vision, dry eye, and retinopathy. MEK inhibitors, often used in combination with other therapies, can cause transient retinopathy, subretinal detachments, and visual disturbances like altered color perception and light sensitivity. Systemic chemotherapy can lead to conjunctivitis, dry eyes, and corneal epithelial defects. Regular ophthalmologic monitoring is recommended to manage and mitigate these side effects.

What prior FDA approvals exist?

As of now, there are no FDA-approved Protein Kinase C (PKC) inhibitors specifically for the treatment of Uveal Melanoma. However, other targeted therapies and immunotherapies have been explored and approved for related conditions. For instance, immune checkpoint inhibitors like pembrolizumab and nivolumab have been used in the treatment of metastatic melanoma, including cases of Uveal Melanoma. Additionally, therapies targeting specific genetic mutations, such as MEK inhibitors, have shown promise in clinical trials. The ongoing study of IDE196 (darovasertib) represents a novel approach in targeting PKC for Uveal Melanoma.

What other types of research exist?

Promising novel alternatives to IDE196 (darovasertib) for Uveal Melanoma patients include MEK inhibitors such as trametinib and cobimetinib, which have shown efficacy in targeting related pathways. Additionally, investigational therapies targeting specific genetic mutations, such as IDH inhibitors (e.g., ivosidenib) and dual mutant-IDH1/2 inhibitors (e.g., vorasidenib), are being explored. Immunotherapies, including checkpoint inhibitors and anti-KIR antibodies, are also under investigation and may offer new treatment avenues.

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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

Must not have

Concurrent malignant disease

Malabsorption disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose to end of follow-up, approximately 44 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IDE196 (darovasertib) in patients with primary uveal melanoma needing surgery or radiation. The medication is given to help shrink the tumor and prevent it from coming back.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any other types of cancer.

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I have a condition that affects how my body absorbs nutrients.

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I have heart problems that affect my daily activities.

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I have an active HIV, Hepatitis B, or Hepatitis C infection.

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I have been treated with a PKC inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose to end of follow-up, approximately 44 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assessment of visual acuity loss

Evaluate tumor response to neoadjuvant IDE196

Rate of local disease recurrence

+1 more

Other study objectives

Overall survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: darovasertibExperimental Treatment1 Intervention

IDE196 (darovasertib) oral open label

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Uveal Melanoma include Protein Kinase C (PKC) inhibitors, such as IDE196 (darovasertib), which target the PKC pathway involved in cell proliferation and survival. By inhibiting PKC, these drugs can reduce tumor growth and potentially lead to tumor regression. This is particularly important for Uveal Melanoma patients as the disease is often aggressive and resistant to conventional therapies. Other treatments may include immune checkpoint inhibitors, which enhance the body's immune response against tumor cells, and targeted therapies that focus on specific genetic mutations within the tumor. These mechanisms are crucial as they offer more personalized and effective treatment options, improving the prognosis and quality of life for patients with Uveal Melanoma.