Melanoma Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT05907954

Recruitment Status:

Recruiting

Sponsor:

IDEAYA Biosciences

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There are 21 Locations for this study

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HonorHealth Research Institute
Scottsdale Arizona, 85258, United States More Info
UCLA Medical Center
Los Angeles California, 90024, United States More Info
Adyel Annelus
Contact
310-794-4955
[email protected]
Elizabeth Seja
Contact
310-794-6892
[email protected]
Sarah Cannon Research Institute
Denver Colorado, 80218, United States More Info
Sarah Cannon
Contact
720-754-2610
[email protected]
University of Miami
Miami Florida, 33146, United States More Info
Clinical Trials Group
Contact
[email protected]
The Cancer and Hematology Centers
Grand Rapids Michigan, 49546, United States More Info
The Cancer and Hematology Centers of Western Michigan
Contact
616-954-5550
[email protected]
Jessica Miller, RN
Contact
616-954-5550
[email protected]
Northwell
Manhasset New York, 11030, United States More Info
Leila Nasr, BS
Contact
646-785-8203
[email protected]
Duke University Health System
Durham North Carolina, 27710, United States More Info
Carol Ann Wiggs, BSN
Contact
919-684-0281
[email protected]
Emily Bolch
Contact
919-668-6359
[email protected]
Wills Eye Hospital/Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Ask Sarah
Contact
844-482-4812
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
James Harbour, MD
Contact
214-648-3407
[email protected]
Juan Mo, PhD
Contact
(214) 645-3087
[email protected]
St. Vincent's Health Sydney
Sydney New South Wales, 2010, Australia More Info
Alfred Health
Melbourne Victoria, 3004, Australia More Info
Chris Brooks
Contact
[email protected]
Princess Margaret Cancer Centre
Toronto Ontario, M5G2M, Canada More Info
Marcus Butler, MD
Contact
416-946-4501
[email protected]
Institute Curie
Paris , , France
Charite Comprehensive Cancer Center
Berlin , D-101, Germany
University Hospital Essen - West German Cancer Center
Essen , 45147, Germany
Instituto Nazionale Tumori di Milano
Milano , 20133, Italy
Instituto Nazionale Tumori IRCCS - Fondazione Pascale
Naples , 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome , 00168, Italy
Leiden University Medical Center
Leiden , 2333 , Netherlands
The Clatterbridge Cancer Centre NHS FT
Liverpool , L7 8Y, United Kingdom
University College London Hospital - NHS Foundation Trust
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT05907954

Recruitment Status:

Recruiting

Sponsor:


IDEAYA Biosciences

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