Melanoma Clinical Trial

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

Summary

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).

View Full Description

Full Description

This study is designed as a multi-stage Phase 2 study within a Phase 3 study to evaluate the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor activity of IDE196 in combination with crizotinib compared to the comparator arm of investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

The Phase 2a dose optimization stage will evaluate two doses of IDE196 in combination with crizotinib compared to the comparator arm. Participants will be randomized to the three treatment arms. At the point of optimal IDE196 + crizotinib dose selection, the other dose arm will be dropped with discontinuation of enrollment to that arm. Participants receiving the IDE196 dose (in combination with crizotinib) that is not selected, will be offered the choice to remain on the same dose or change to the chosen optimal dose.

The optimal dose will be chosen to complete the Phase 2b portion. The Phase 2b part of the study will continue to enroll the chosen combination dose of IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to the two treatment arms.

The Phase 3 part of the study will continue to enroll the chosen combination dose of IDE196 + crizotinib compared with the comparator arm. Participants will be randomized to the two treatment arms.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histological or cytological confirmed Metastatic Uveal Melanoma
HLA-A*02:01 negative
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
Measurable disease per RECIST 1.1
Able to be safely administered and absorb study therapy
ECOG performance status 0 or 1
Life expectancy of ≥3 months
Adequate organ function

Exclusion Criteria:

Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11
Concurrent malignant disease
AEs from prior anti-cancer therapy that have not resolved to Grade ≤1
Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids
Active HIV infection or Hep B/C
Active adrenal insufficiency, active colitis, or active inflammatory bowel disease
History of interstitial lung disease, active pneumonitis, or history of pneumonitis
Active infection requiring systemic antibiotic therapy
Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug
Females who are pregnant or breastfeeding
History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
Contraindication for treatment with investigator's choice therapies as per applicable labelling
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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

380

Study ID:

NCT05987332

Recruitment Status:

Recruiting

Sponsor:

IDEAYA Biosciences

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There are 60 Locations for this study

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Honor Health
Scottsdale Arizona, 85258, United States More Info
Oncology Clinical Trials Nurse Navigator
Contact
480-323-1791
[email protected]
Contact
833-354-6667
Moores Cancer Center
La Jolla California, 92093, United States More Info
Katie O'Neil, BA
Contact
858-822-5354
[email protected]
Jazelle Molina
Contact
858-822-5354
[email protected]
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]
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Saba Mukarram
Contact
310-231-2181
[email protected]
California Pacific Medical Center (CPMC)
San Francisco California, 94115, United States More Info
Denise Fortun
Contact
415-600-1775
[email protected]
CPMC Clinical Research Group
Contact
[email protected]
University of California San Francisco
San Francisco California, 94143, United States More Info
Sonia Contreras Martinez, BSN
Contact
415-514-6427
[email protected]
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
SCRI at HealthONE
Denver Colorado, 80218, United States More Info
SCRI Front Desk
Contact
720-754-2610
[email protected]
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Moffitt Cancer Center
Tampa Florida, 33612, United States
Northside Hospital Atlanta
Atlanta Georgia, 30342, United States More Info
Central Research Department
Contact
404-303-3355
[email protected]
University of Iowa
Iowa City Iowa, 52242, United States More Info
Asad Javed, MD
Contact
319-467-5156
[email protected]
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Kamaneh Montazeri, MD
Contact
617-724-4000
[email protected]
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Rizwan Haq
Contact
617-632-6168
[email protected]
Linnea Drew
Contact
617-632-6705
[email protected]
The Cancer and Hematology Centers
Grand Rapids Michigan, 49546, United States More Info
The Cancer and Hematology Centers
Contact
616-954-5550
[email protected]
Jessica Miller, RN
Contact
616-954-5550
[email protected]
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 More Info
Benjamin Switzer, DO
Contact
716-845-7668
[email protected]
igor Puzanov, MD
Contact
716-845-7505
[email protected]
Northwell Health
Manhasset New York, 11030, United States More Info
Richard Carvajal, MD
Contact
[email protected]
Tracy Green, BS
Contact
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Alexander Shoushtari, MD
Contact
646-888-4161
[email protected]
James Smithy, MD
Contact
929-623-0275
[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]
University of Cincinnati
Cincinnati Ohio, 45267, United States More Info
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Lucy Kennedy, MD
Contact
216-317-5561
[email protected]
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Marlana Orloff
Contact
215-955-9980
[email protected]
Kristie Hensel
Contact
215-955-9980
[email protected]
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States More Info
Amy Rose, RN,BSN
Contact
412-647-8587
[email protected]
Jennifer Cleric, ND, RN
Contact
412-864-7893
[email protected]
SCRI- Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
SCRI Front Desk
Contact
844-482-4812
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Sanjay Chandrasekaran, MD
Contact
833-722-6237
[email protected]
Desiree Pierre, BS
Contact
214-648-3111
[email protected]
Houston Methodist Cancer Center
Houston Texas, 77030, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Sapna Patel, MD
Contact
713-792-2921
[email protected]
Westmead Hospital
Sydney New South Wales, 2145, Australia More Info
Matteo Carlino, MD
Contact
+61 288 905 200
[email protected]
Princess Alexander Hospital
Brisbane Queensland, 4102, Australia More Info
Janine Thomas
Contact
+61(0)731767578
[email protected]
Alfred Health
Melbourne Victoria, 3168, Australia
Sir Charles Gairdner Hospital
Perth Western Australia, 6009, Australia More Info
Joanne Tonkin
Contact
0863833185
[email protected]
Rose McDowell
Contact
0863833190
[email protected]
Queen Elizabeth Hospital
Adelaide , , Australia
Cliniques Universitaires Saint Luc
Brussels , 1200, Belgium More Info
Jean Francois Baurain, MD
Contact
[email protected]
Cross Cancer Institute, University of Alberta
Edmonton Alberta, T6G 1, Canada More Info
John Walker, MD,PhD,FRCPC
Contact
780-577-8082
[email protected]
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Marcus Butler
Contact
416-946-4501
[email protected]
Centre Hospitalier de l'Universite de Montreal- CHUM
Montréal Quebec, H2X 0, Canada More Info
Rahima Jamal, MD
Contact
514-890-8444
[email protected]
Chantal Gosselin
Contact
514-890-8000
[email protected]
The Leon Berard Center
Lyon , , France More Info
Eve-Marie Neidhardt, MD
Contact
[email protected]
Institut Curie
Paris , 75005, France More Info
Sophie Piperno-Neumann, MD
Contact
+33 0 1 44 32 40 68
[email protected]
NCT Heidelberg
Heidelberg Baden- Württemberg, 69120, Germany More Info
Jessica Hassel, Prof. Dr. med
Contact
[email protected]
Universitätsklinikum Essen (AöR)
Essen North Rhine-Westphalia, 45147, Germany More Info
Halime Kalkavan, Dr. med
Contact
+49 201 72384150
[email protected]
Universitätsklinikum Köln
Köln North Rhine-Westphalia, 50937, Germany More Info
Nicole Kreuzberg, MD
Contact
[email protected]
Universitätsklinikum Carl Gustav Carus Dresden
Dresden Saxony, 1307, Germany More Info
Friedegund Meier, Prof. Dr. med
Contact
+49 (0) 351 458 19782
[email protected]
Charité - Universitätsmedizin Berlin
Berlin , 12203, Germany More Info
Caroline Anna Peuker, MD
Contact
+49 30 450 513470
[email protected]
Hadassah Medical Center
Jerusalem , 91120, Israel More Info
Jonathan Cohen, MD
Contact
972 50 5172537
[email protected]
Annaelle Dynovisz, SC
Contact
972-58-4820222
[email protected]
Sheba Medical Center
Ramat-Gan , 52621, Israel More Info
Ronnie Shapira, MD
Contact
972 3-5302243
[email protected]
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy More Info
Lorenza DiGuardo, MD
Contact
0039 02 23905000
[email protected]
Istituto Nazionale dei Tumori Fondazione Pascale
Napoli , 80131, Italy More Info
Paolo Ascierto, MD
Contact
+39 081 17770810
[email protected]
Fondazione Policlinico Gemelli IRCCS
Roma , 00168, Italy More Info
Ernesto Rossi, MD
Contact
+39 06 30156318
[email protected]
AOUS Policlinico Le Scotte
Siena , 53100, Italy More Info
Michele Maio, MD
Contact
+39 0577586304
[email protected]
LUMC (Leids Universitair Medisch Centrum)
Leiden , 2333 , Netherlands More Info
Ellen Kapiteijn, MD
Contact
+31 (0)71 526 1093
[email protected]
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdańsk , 80-21, Poland More Info
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy
Warsaw , 02-78, Poland More Info
Catalan Institute of Oncology
L'Hospitalet de Llobregat , 8908, Spain More Info
Josep Maria Piulats, MD
Contact
+34 932607744
[email protected]
Hospital Universitario La Paz
Madrid , 28046, Spain More Info
Yolanda Alvarez, BSc
Contact
[email protected]
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela , 15706, Spain More Info
Estiban Mendez, Bsc
Contact
+34 663 609 134
[email protected]
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain More Info
María del Carmen Álamo, MD
Contact
+34 629 310 196 (611565)
[email protected]
María Candón, SC
Contact
+34 629 310 196 (611565)
[email protected]
Hospital General Universitario Valencia
Valencia , 46014, Spain More Info
Alfonso Berrocal, MD
Contact
+34 96 313 18 00
[email protected]
Dermatologische Klinik, USZ Flughafen Geschoss 7 - Klinische Forschung
Zuerich , 8058, Switzerland More Info
Reinhard Dummer, Prof. Dr. med
Contact
0041 44 255 25 88
[email protected]
The Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom More Info
Mount Vernon Cancer Centre East & North Herts NHS Trust
Northwood , HA6 2, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral , CH63 , United Kingdom More Info
Joseph Sacco, Professor
Contact
0151 556 5000
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

380

Study ID:

NCT05987332

Recruitment Status:

Recruiting

Sponsor:


IDEAYA Biosciences

How clear is this clinincal trial information?

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