Health TrialsbyHealthPanel

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

ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIDEAYA Biosciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Darovasertib

    Drug

    Oral, selectively targets key proteins

  • Crizotinib (Xalkori)

    Drug

    Oral small molecule

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 2 interventions
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Median relapse-free survival

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

Time frame
Approximately 5 years

Secondary outcomes

1

Median metastasis-free survival

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

Time frame
Approximately 5 years
2

Overall survival

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

Time frame
Approximately 5 years
3

Median UM specific survival

Median UM specific survival defined as the time from randomization to the date of death due to UM

Time frame
Approximately 5 years
4

Median metastasis-free survival

Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator

Time frame
Approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IDEAYA Biosciences

Lead sponsor

Source ClinicalTrials.gov
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