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

11 september 2026 uppdaterad 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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

450

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Arizona
      • Scottsdale, Arizona, Förenta staterna, 85258
        • Rekrytering
        • Honor Health Research Institute
        • Kontakt:
    • California
      • Los Angeles, California, Förenta staterna, 90024
        • Har inte rekryterat ännu
        • UCLA Medical Center
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
        • Har inte rekryterat ännu
        • Dana Farber Cancer Institute
        • Kontakt:
    • Michigan
      • Grand Rapids, Michigan, Förenta staterna, 49503
        • Har inte rekryterat ännu
        • Cancer Hematology Centers Western Michigan
        • Kontakt:
    • New York
      • New York, New York, Förenta staterna, 10065
        • Har inte rekryterat ännu
        • Memorial Sloan Kettering Cancer Center
        • Kontakt:
      • New York, New York, Förenta staterna, 10075
        • Har inte rekryterat ännu
        • Northwell Health
        • Kontakt:
    • North Carolina
      • Raleigh, North Carolina, Förenta staterna, 27710
        • Har inte rekryterat ännu
        • Duke Cancer Center
        • Kontakt:
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Har inte rekryterat ännu
        • Cleveland Clinic
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • Rekrytering
        • Wills Eye Hospital at Thomas Jefferson University
        • Kontakt:
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37203
        • Rekrytering
        • Sarah Cannon Research Institute (SCRI)
        • Kontakt:
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53792
        • Har inte rekryterat ännu
        • University of Wisconsin Health
        • Kontakt:
  • Kanada
    • Ontario
      • Montréal, Ontario, Kanada, H2X0C1
        • Har inte rekryterat ännu
        • Universite de Montreal - Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
        • Kontakt:
      • Toronto, Ontario, Kanada, M5G 2M9
        • Rekrytering
        • Princess Margaret Cancer Centre
        • Kontakt:
          • Marcus Butler, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment
Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested
Läkemedel: Darovasertib
Oral, selectively targets key proteins
Läkemedel: Crizotinib (Xalkori)
Oral small molecule
Inget ingripande: Observation
Participant Group/Arm: Observation Standard of care observation & follow-up (no treatment)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Median relapse-free survival
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Median metastasis-free survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: [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)
Tidsram: [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]

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

IDEAYA Biosciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 mars 2034

Avslutad studie (Beräknad)

1 april 2034

Studieregistreringsdatum

Först inskickad

21 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

31 augusti 2026

Första postat (Faktisk)

4 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IDE196-011

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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