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Darovasertib + Crizotinib for Uveal Melanoma

Phase 2 & 3

Recruiting

Research Sponsored by IDEAYA Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior systemic therapy in the metastatic or advanced setting, regional or liver-directed therapy, ablations or surgical resection of oligometastatic disease, or neoadjuvant or adjuvant therapy is allowed

ECOG performance status 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Awards & highlights

Study Summary

This trial tests different treatments to treat metastatic uveal melanoma in people without certain proteins.

Who is the study for?

This trial is for people with metastatic uveal melanoma who are HLA-A*02:01 negative and haven't had systemic therapy for advanced cancer. They should have measurable disease, be able to take the study drugs safely, have good organ function and physical status, and a life expectancy of at least 3 months.Check my eligibility

What is being tested?

The trial is testing IDE196 combined with crizotinib against other treatments like pembrolizumab or ipilimumab + nivolumab. It's an open-label study where patients are randomly chosen to receive either the combination or one of the standard therapies.See study design

What are the potential side effects?

Possible side effects include allergic reactions similar to those from biologic drugs or monoclonal antibodies, lung issues such as pneumonitis, infections requiring antibiotics, liver problems due to prior treatments not resolved fully, and complications from CNS metastases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had systemic therapy for advanced or metastatic disease, but local treatments are okay.

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I am fully active or can carry out light work.

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My cancer is a type of eye melanoma that has spread.

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I do not have the HLA-A*02:01 gene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS) of IDE196 + Crizotinib compared to investigator's choice of treatment

Progression-Free Survival (PFS) by blinded independent central review (BICR) of IDE196 + Crizotinib compared to investigator's choice of treatment

Secondary outcome measures

Change from baseline over time and between treatment arms in EORTC QLQ-C30

Change from baseline over time and between treatment arms in EuroQoL (EQ)-5D-5L scores

Duration of Response (DOR) per BICR and Investigator assessment of IDE196 + Crizotinib compared to investigator's choice of treatment

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinibExperimental Treatment2 Interventions

Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.

Group II: Phase 2a Dose Optimization of IDE196 + crizotinibExperimental Treatment2 Interventions

Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.

Group III: Phase 2a / 2b / 3 Comparator ArmActive Control4 Interventions

Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Crizotinib

2014

Completed Phase 3

~2370

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

IDEAYA BiosciencesLead Sponsor

4 Previous Clinical Trials

558 Total Patients Enrolled

Oktay Kirak, MDStudy DirectorIDEAYA Biosciences

Matthew Maurer, MDStudy DirectorIDEAYA Biosciences

3 Previous Clinical Trials

408 Total Patients Enrolled

Media Library

Crizotinib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05987332 — Phase 2 & 3

Uveal Melanoma Research Study Groups: Phase 2a / 2b / 3 Comparator Arm, Phase 2a Dose Optimization of IDE196 + crizotinib, Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib

Uveal Melanoma Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT05987332 — Phase 2 & 3

Crizotinib (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05987332 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots to partake in this experiment?

"The details on clinicaltrials.gov display that this medical trial is no longer looking for participants; the study was first posted on July 31st 2023 and its latest update occurred a few days later, on August 3rd 2023. Nonetheless, there are still 735 other trials searching for volunteers as of now."

Answered by AI

What beneficial results are anticipated from this trial?

"This two-year study seeks to evaluate the Overall Survival (OS) of IDE196 + Crizotinib over Investigator's Choice treatments. Secondary objectives include assessing Dose Exposure Response for both IDE196 and Crizotinib in plasma, as well as Progression Free Survival per RECIST 1.1 standards."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

2023. "IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987332.