RECRUITING

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

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Conditions

Metastatic Uveal MelanomaIDE196DarovasertibProtein Kinase CMelanomaOcular OncologyOphthalmologyCrizotinibOcular melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A\*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

Official Title

IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)

Quick Facts

Study Start:2023-10-31
Study Completion:2028-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05987332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histological or cytological confirmed Metastatic Uveal Melanoma
  2. * HLA-A\*02:01 negative
  3. * No prior systemic therapy in the metastatic or advanced setting or regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy is allowed
  4. * Measurable disease per RECIST 1.1
  5. * Able to be safely administered and absorb study therapy
  6. * ECOG performance status 0 or 1
  7. * Life expectancy of ≥3 months
  8. * Adequate organ function
  1. * Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11
  2. * Concurrent malignant disease
  3. * AEs from prior anti-cancer therapy that have not resolved to Grade ≤1
  4. * Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids
  5. * High risk of syncope
  6. * Known AIDS related illness or active Hep B/C
  7. * Active adrenal insufficiency, active colitis, or active inflammatory bowel disease
  8. * History of interstitial lung disease, active pneumonitis, or history of pneumonitis
  9. * Active infection requiring systemic antibiotic therapy
  10. * Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug
  11. * Females who are pregnant or breastfeeding
  12. * History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
  13. * Contraindication for treatment with investigator's choice therapies as per applicable labelling
  14. * History of stroke within the last 6 months of the first dose of study drug
  15. * 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

Contacts and Locations

Study Contact

IDEAYA Clinical Trials
CONTACT
1 650-534-3616
IDEAYAClinicalTrials@ideayabio.com
Hetal Patel, MD, MSHS, CHCQM
CONTACT
650-741-3856
hpatel@ideayabio.com

Principal Investigator

Hetal Patel, MD, MSHS, CHCQM
STUDY_DIRECTOR
IDEAYA Biosciences

Study Locations (Sites)

Honor Health
Scottsdale, Arizona, 85258
United States
Moores Cancer Center
La Jolla, California, 92093
United States
UCLA Medical Center
Los Angeles, California, 90024
United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
United States
California Pacific Medical Center (CPMC)
San Francisco, California, 94115
United States
University of California San Francisco
San Francisco, California, 94143
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
SCRI at HealthONE
Denver, Colorado, 80218
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Northside Hospital Atlanta
Atlanta, Georgia, 30342
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49546
United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Northwell Health
Manhasset, New York, 11030
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University Health System
Durham, North Carolina, 27710
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology- DFW
Dallas, Texas, 75246
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Houston Methodist Cancer Center
Houston, Texas, 77030
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: IDEAYA Biosciences

  • Hetal Patel, MD, MSHS, CHCQM, STUDY_DIRECTOR, IDEAYA Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-31
Study Completion Date2028-01-15

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2028-01-15

Terms related to this study

Keywords Provided by Researchers

  • IDE196
  • Darovasertib
  • Protein Kinase C
  • Metastatic Uveal Melanoma
  • Melanoma
  • Ocular Oncology
  • Ophthalmology
  • Crizotinib
  • Ocular melanoma

Additional Relevant MeSH Terms

  • Metastatic Uveal Melanoma