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New pill could save eyes from melanoma surgery

NCT ID NCT05907954

Disease control Sponsor: IDEAYA Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests darovasertib, a daily pill, in 160 people with uveal melanoma (a rare eye cancer). The drug is given before and after standard treatments like surgery or radiation. The main goals are to see if the pill can shrink tumors enough to avoid eye removal, reduce radiation dose to healthy eye parts, and control small tumors. Researchers are also checking for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Darovasertib (also called IDE196), a pill that blocks a protein involved in melanoma growth
What this could lead to
If it works, this could offer a way to treat uveal melanoma without removing the eye, possibly saving vision and reducing radiation damage.
What could go wrong
This is a mid-stage trial with 160 people, so results are not final. The drug may cause side effects or not shrink tumors enough to change standard care.
Why investors are watching

Ideaya Biosciences is testing its drug darovasertib in patients with localized uveal melanoma, a rare eye cancer, in a phase 2 trial with 160 planned participants. For a small company, this readout matters because darovasertib is a key pipeline asset, and a positive result could support its use before or after surgery. The outcome will help investors gauge whether the drug works beyond the advanced disease settings where it is also being studied.

If it works: A positive result could strengthen the case for darovasertib as a treatment for earlier-stage uveal melanoma, potentially expanding its market and supporting regulatory discussions. That could increase the drug's commercial value for Ideaya.

If it fails: A failure or delay could set back the drug's development timeline and hurt the company's prospects, since small companies often depend on a single lead asset. Trials fail often, so a negative readout is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy * Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is \< 4 mm in thickness requiring treatment * Able to dose orally * ECOG Performance status of 0-1 * No other significant underlying ocular disease * Adequate organ function * Not pregnant/nursing or planning to become pregnant. Willing to use birth control Exclusion Criteria: * Previous treatment with a Protein Kinase C (PKC) inhibitor * Concurrent malignant disease * Active HIV infection or Hep B/C * Malabsorption disorder * Unable to discontinue prohibited medication * Impaired cardiac function or clinically significant cardiac disease * Any other condition which may interfere with study interpretation or results

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Conditions

The condition(s) this trial relates to.

Plaque, Amyloid uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uveal melanoma

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168, Italy

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • Institute Curie

    Paris, 75005, France

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Moores Cancer Center

    La Jolla, California, 92093, United States

  • Northwell

    Manhasset, New York, 11030, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2M9, Canada

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • St. Vincent's Health Sydney

    Sydney, New South Wales, 2010, Australia

  • Stanford Cancer Institute

    Palo Alto, California, 94305, United States

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan, 49546, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

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