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New drug cocktail aims to fight deadly eye cancer

NCT ID NCT05987332

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a combination of two oral drugs, darovasertib and crizotinib, against standard treatments (immunotherapy or chemotherapy) in 420 people with a specific type of advanced eye melanoma that has spread. Participants must have a certain genetic marker (HLA-A2 negative) and not have had prior systemic therapy. The goal is to see if the new combo improves how long people live without their cancer growing or overall survival.

What this could mean

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

Active substance
Darovasertib (IDE196) plus crizotinib
What this could lead to
If successful, this combination could become a new first-line treatment option for people with a specific type of metastatic eye melanoma, potentially improving survival.
What could go wrong
This is an early-to-mid stage trial (Phase 2/3) with no results yet. The combination may not work better than existing therapies, and side effects from the drugs could be significant.
Why investors are watching

Ideaya Biosciences runs this trial to test whether IDE196 plus crizotinib controls metastatic uveal melanoma better than existing options in patients who are HLA-A2 negative. For a small company, this readout matters because it is a late-stage test of its lead drug in a disease with few good treatments.

If it works: A positive result may support regulatory discussions and give Ideaya a larger role in treating metastatic uveal melanoma.

If it fails: A failure or delay may set back the program and force the company to depend on earlier-stage assets. Most oncology trials do not succeed.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 420 people

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

Started

Oct 2023

Expected to finish

Jan 2028

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: * Histological or cytological confirmed Metastatic Uveal Melanoma * HLA-A\*02:01 negative * No prior systemic therapy in the metastatic or advanced setting regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy is allowed * Measurable disease per RECIST 1.1 * Able to be safely administered and absorb study therapy * ECOG performance status 0 or 1 * Life expectancy of ≥3 months * Adequate organ function Exclusion Criteria: * Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11 * Concurrent malignant disease * AEs from prior anti-cancer therapy that have not resolved to Grade ≤1 * Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids * High risk of syncope or falls * Known AIDS related illness * Active adrenal insufficiency, active colitis, or active inflammatory bowel disease * History of interstitial lung disease, active pneumonitis, or history of pneumonitis requiring steroids * Active infection requiring systemic antibiotic therapy or active Hepatitis B/C * Major surgery, radiotherapy, or use of hematopoietic colony-stimulating factors (CSF) within 2 weeks prior to start of study drug * Females who are pregnant or breastfeeding * History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies * Contraindication for treatment with investigator's choice therapies as per applicable labelling * History of stroke within the last 6 months of the first dose of study drug * Impaired Cardiac function or clinically significant cardiac diseases, including angina pectoris or acute myocardial infarction \<= 6 months prior to start of study treatment * Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the participant inappropriate for entry into the study, including institutionalization on the basis of an official or court order

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma uveal melanoma

As listed by the trial registrant

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

Metastatic uveal melanoma

Contacts and locations

Locations

  • AOUS Policlinico Le Scotte

    Siena, 53100, Italy

  • Alfred Health

    Melbourne, Victoria, 3168, Australia

  • Algemene Medische Oncologie UZ

    Leuven, 3000, Belgium

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z4C2, Canada

  • California Pacific Medical Center (CPMC)

    San Francisco, California, 94115, United States

  • Catalan Institute of Oncology

    L'Hospitalet de Llobregat, 8908, Spain

  • Centre Hospitalier de l'Universite de Montreal- CHUM

    Montreal, Quebec, H2X 0C1, Canada

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Cross Cancer Institute, University of Alberta

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung

    Zurich, 8058, Switzerland

  • Duke University Health System

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione Policlinico Gemelli IRCCS

    Roma, 00168, Italy

  • Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Honor Health

    Scottsdale, Arizona, 85258, United States

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital General Universitario Valencia

    Valencia, 46014, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Institut Curie

    Paris, 75005, France

  • Istituto Nazionale dei Tumori Fondazione Pascale

    Naples, 80131, Italy

  • LUMC (Leids Universitair Medisch Centrum)

    Leiden, 2333 ZA, Netherlands

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota, 55337, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Moores Cancer Center

    La Jolla, California, 92093, United States

  • Mount Vernon Cancer Centre East & North Herts NHS Trust

    Northwood, HA6 2RN, United Kingdom

  • NCT Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • Northside Hospital Atlanta

    Atlanta, Georgia, 30342, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne w Gdańsku

    Gdansk, 80-214, Poland

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Alexander Hospital

    Brisbane, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital

    Adelaide, Australia

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • SCRI at HealthONE

    Denver, Colorado, 80218, United States

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Sir Charles Gairdner Hospital

    Perth, Washington, 6009, Australia

  • Texas Oncology- DFW

    Dallas, Texas, 75246, United States

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025, United States

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan, 49546, United States

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Leon Berard Center

    Lyon, France

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Medical Center

    Los Angeles, California, 90024, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 1307, Germany

  • Universitätsklinikum Essen (AöR)

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Westmead Hospital

    Sydney, New South Wales, 2145, Australia

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Other studies related to the condition(s) this trial covers.