(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Uveal Melanoma Clinical Trial

Official title:

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907954
• Other study ID #: IDE196-009
• Status: Recruiting
• Phase: Phase 2
• Start date: July 3, 2023
• Est. completion date: January 31, 2029

Study information

• Verified date: November 2023
• Source: IDEAYA Biosciences
• Contact: IDEAYA Clinical Trials
• Phone: 1 650-534-3616
• Email: IDEAYAClinicalTrials[@]ideayabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma

Intervention

Drug:
• Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria
Australia	St. Vincent's Health Sydney	Sydney	New South Wales
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
France	Institute Curie	Paris
Germany	Charite Comprehensive Cancer Center	Berlin
Germany	University Hospital Essen - West German Cancer Center	Essen
Italy	Instituto Nazionale Tumori di Milano	Milano
Italy	Instituto Nazionale Tumori IRCCS - Fondazione Pascale	Naples
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome
Netherlands	Leiden University Medical Center	Leiden
United Kingdom	The Clatterbridge Cancer Centre NHS FT	Liverpool
United Kingdom	University College London Hospital - NHS Foundation Trust	London
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Sarah Cannon Research Institute	Denver	Colorado
United States	Duke University Health System	Durham	North Carolina
United States	The Cancer and Hematology Centers	Grand Rapids	Michigan
United States	UCLA Medical Center	Los Angeles	California
United States	Northwell	Manhasset	New York
United States	University of Miami	Miami	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Wills Eye Hospital/Thomas Jefferson University	Philadelphia	Pennsylvania
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
IDEAYA Biosciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	Evaluate patient survival status	from date of first dose to end of follow-up, approximately 44 months
Primary	Incidence of Adverse Events (AEs) and significant laboratory abnormalities	Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.	from first dose to last dose of adjuvant therapy, approximately 12 months
Primary	Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation	Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy	from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Primary	Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose	Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy	from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary	Evaluate tumor response to neoadjuvant IDE196	Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters)	from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months
Secondary	Assessment of visual acuity loss	Best corrected visual acuity loss over time	from time of primary local therapy to one year after surgery, approximately 12 months
Secondary	Rate of local disease recurrence	Evaluate uveal melanoma progression or recurrence	from date of primary local therapy to end of follow-up, approximately 36 months
Secondary	Rate of metastatic disease	Evaluate occurrence of metastatic uveal melanoma	from date of primary local therapy to end of follow-up, approximately 36 months