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Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

9. november 2026 oppdatert av: IDEAYA Biosciences

A Randomized, Phase 3, Open-label Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma

This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment.

The Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib.

The Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm)

Participants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.

Studietype

Intervensjonell

Registrering (Antatt)

450

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Har ikke rekruttert ennå
        • Alfred Health
        • Ta kontakt med:
  • Canada
    • Ontario
      • Montréal, Ontario, Canada, H2X0C1
        • Har ikke rekruttert ennå
        • Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
        • Ta kontakt med:
      • Toronto, Ontario, Canada, M5G 2M9
        • Rekruttering
        • Princess Margaret Cancer Centre
        • Ta kontakt med:
          • Marcus Butler, MD
  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85258
        • Rekruttering
        • Honor Health Research Institute
        • Ta kontakt med:
    • California
      • Los Angeles, California, Forente stater, 90024
        • Har ikke rekruttert ennå
        • UCLA Medical Center
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90025
        • Har ikke rekruttert ennå
        • Angeles Clinic
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92037
        • Har ikke rekruttert ennå
        • University of California, San Diego
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94158
        • Har ikke rekruttert ennå
        • University of California, San Francisco
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94115
        • Har ikke rekruttert ennå
        • Sutter Health CPMC
        • Ta kontakt med:
    • Florida
      • Miami, Florida, Forente stater, 33136
        • Har ikke rekruttert ennå
        • University of Miami
        • Ta kontakt med:
      • Tampa, Florida, Forente stater, 33612
        • Har ikke rekruttert ennå
        • USF Health Eye Institute
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Har ikke rekruttert ennå
        • Dana Farber Cancer Institute
        • Ta kontakt med:
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49503
        • Har ikke rekruttert ennå
        • Cancer Hematology Centers Western Michigan
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10065
        • Har ikke rekruttert ennå
        • Memorial Sloan Kettering Cancer Center
        • Ta kontakt med:
      • New York, New York, Forente stater, 10075
        • Har ikke rekruttert ennå
        • Northwell Health
        • Ta kontakt med:
      • New York, New York, Forente stater, 10032
        • Har ikke rekruttert ennå
        • Columbia University - Herbert Irving Comprehensive Cancer Center
        • Ta kontakt med:
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27710
        • Rekruttering
        • Duke Cancer Center
        • Ta kontakt med:
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Rekruttering
        • Cleveland Clinic
        • Ta kontakt med:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Rekruttering
        • Wills Eye Hospital at Thomas Jefferson University
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • Sarah Cannon Research Institute (SCRI)
        • Ta kontakt med:
    • Texas
      • Dallas, Texas, Forente stater, 75390
      • Houston, Texas, Forente stater, 77030
        • Har ikke rekruttert ennå
        • UT MD Anderson Cancer Center
        • Ta kontakt med:
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • Har ikke rekruttert ennå
        • University of Wisconsin Health
        • Ta kontakt med:
  • Israel
      • Jerusalem, Israel, 9112001
        • Har ikke rekruttert ennå
        • Hadassah Medical Center
        • Ta kontakt med:
      • Ramat Gan, Israel, 5265601
  • Storbritannia
      • Glasgow, Storbritannia, G120XH
        • Har ikke rekruttert ennå
        • Beatson West of Scotland Cancer Centre
        • Ta kontakt med:
      • Northwood, Storbritannia, HA62RN
        • Har ikke rekruttert ennå
        • Mount Vernon Hospital
        • Ta kontakt med:
  • Sveits
      • Zurich, Sveits, 8058
        • Har ikke rekruttert ennå
        • University of Zurich Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3)
  • Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy)
  • ECOG performance status of 0 or 1
  • Adequate organ function
  • Age 18 or older
  • Written informed consent and ability to comply
  • Primary local therapy completed within 120 days before C1D1/randomization.
  • Contraception requirements

Exclusion Criteria:

  • Previous systemic treatment for Uveal Melanoma
  • Clinical or radiological evidence of metastatic UM
  • Concurrent malignant disease with the following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)
  • Known AIDS related illness
  • History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
  • History of syncope may be exclusionary, but will be reviewed on a case-by-case basis
  • Active Hepatitis B or C infection
  • Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow
  • Females who are pregnant or breastfeeding
  • Impaired cardiac function
  • History of stroke within the last 6 months of randomization
  • Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib
  • allergy to mammalian meat products or gelatin

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment

Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
Legemiddel: Darovasertib

Oral, selectively targets key proteins

Legemiddel: Crizotinib (Xalkori)

Oral small molecule
Ingen inngripen: Observation

Participant Group/Arm: Observation Standard of care observation & follow-up (no treatment)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Median relapse-free survival
Tidsramme: Approximately 5 years

Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Approximately 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Median metastasis-free survival
Tidsramme: Approximately 5 years

Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) by BICR per RECIST v 1.1
Approximately 5 years
Overall survival
Tidsramme: Approximately 5 years

Overall survival with darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease who are at high-risk for recurrence
Approximately 5 years
Median UM specific survival
Tidsramme: Approximately 5 years

Median UM specific survival defined as the time from randomization to the date of death due to UM
Approximately 5 years
Median metastasis-free survival
Tidsramme: Approximately 5 years

Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator
Approximately 5 years
Safety, and severity of occurrence of adverse events (AEs) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V6.0 or later
Tidsramme: Approximately 3 years

To assess safety and tolerability of darovasertib + crizotinib in participants who have completed PLT for primary UM
Approximately 3 years
Change from baseline over time and across Treatment Arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)
Tidsramme: Approximately 5 years

Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Approximately 5 years
Recurrence-free suvival
Tidsramme: Approximately 5 years

Compare RFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Approximately 5 years
Metastasis-Free Survival
Tidsramme: Approximately 5 years

Compare MFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Approximately 5 years
Median Local Recurrence-Free Survival
Tidsramme: Approximately 5 years

Compare local RFS (LRFS) of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Approximately 5 years
Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.
Tidsramme: [Time Frame: Approximately 5 years]

Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
[Time Frame: Approximately 5 years]
Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)
Tidsramme: [Time Frame: Approximately 5 years]

Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
[Time Frame: Approximately 5 years]

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

IDEAYA Biosciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. september 2026

Primær fullføring (Antatt)

1. mars 2034

Studiet fullført (Antatt)

1. april 2034

Datoer for studieregistrering

Først innsendt

21. august 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IDE196-011

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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