Clinical trial NCT05907954: (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Official title: (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Uveal Melanoma
Keywords: Uveal Melanoma
Plaque brachytherapy
Enucleation
Neoadjuvant
Adjuvant
Protein Kinase C
Ophthalmology
Ocular Oncology
Darovasertib
IDE196
Ocular melanoma
Choroid melanoma
Plaque
Brachytherapy
Lead sponsor: IDEAYA Biosciences
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Detailed description: Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Eligibility criteria: Inclusion Criteria:

* Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
* Able to dose orally
* ECOG Performance status of 0-1
* No other significant underlying ocular disease
* Adequate organ function
* Not pregnant/nursing or planning to become pregnant. Willing to use birth control

Exclusion Criteria:

* Previous treatment with a Protein Kinase C (PKC) inhibitor
* Concurrent malignant disease
* Active HIV infection or Hep B/C
* Malabsorption disorder
* Unable to discontinue prohibited medication
* Impaired cardiac function or clinically significant cardiac disease
* Any other condition which may interfere with study interpretation or results

Primary outcomes:
measure: Incidence of Adverse Events (AEs) and significant laboratory abnormalities
timeFrame: from first dose to last dose of adjuvant therapy, approximately 12 months
measure: Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
timeFrame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
measure: Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
timeFrame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary outcomes:
measure: Evaluate tumor response to neoadjuvant IDE196
timeFrame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
measure: Assessment of visual acuity loss
timeFrame: from time of primary local therapy to one year after surgery, approximately 12 months
measure: Rate of local disease recurrence
timeFrame: from date of primary local therapy to end of follow-up, approximately 36 months
measure: Rate of metastatic disease
timeFrame: from date of primary local therapy to end of follow-up, approximately 36 months
Other outcomes:
measure: Overall survival
timeFrame: from date of first dose to end of follow-up, approximately 44 months
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: La Jolla
country: United States
facility: Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Grand Rapids
country: United States
facility: The Cancer and Hematology Centers
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Manhasset
country: United States
facility: Northwell
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Sydney
country: Australia
facility: St. Vincent's Health Sydney
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Paris
country: France
facility: Institute Curie
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Essen
country: Germany
facility: University Hospital Essen - West German Cancer Center
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Napoli
country: Italy
facility: Instituto Nazionale Tumori IRCCS - Fondazione Pascale
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: London
country: United Kingdom
facility: University College London Hospital - NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
Study officials:
affiliation: IDEAYA Biosciences
name: Jasgit Sachdev, MD
role: STUDY_DIRECTOR
References: