Testing a New Drug Before Eye Cancer Surgery to Help Prevent the Cancer from Coming Back
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
In Plain English
This study is testing whether giving you a new drug called darovasertib before your scheduled eye cancer treatment can help prevent your cancer from returning. Right now, doctors treat uveal melanoma (eye cancer) with either radiation seeds placed on your eye (plaque brachytherapy) or by removing the eye (enucleation). This trial asks: what if we give you darovasertib pills first to shrink or weaken the tumor, and then do the standard treatment? The hope is that this combination approach will work better than the standard treatment alone. You'll be randomly assigned to either receive darovasertib before your treatment (the new approach) or go straight to your standard treatment (the current approach). The drug is taken by mouth twice a day for cycles of 28 days. After your local therapy is complete, doctors will follow you for up to 3 years to check whether your cancer comes back, how well you can see, and how you're doing overall. This is a Phase 3 trial, which means the drug has already been tested in earlier studies and now researchers want to confirm it actually helps patients like you. You'll be cared for at multiple medical centers, and your doctors will know you're receiving the drug (it's not blinded).
What This Trial Does
This is a , randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non- uveal melanoma (OptimUM-10)
How It Works
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.
Who Can Join
Inclusion Criteria
- Primary non-metastatic uveal melanoma
- Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
- ECOG 0 or 1
- Adequate organ function
Exclusion Criteria
- Previous treatment for UM
- Evidence of metastatic UM
- Attributes that necessitate enucleation regardless of response to therapy
- Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
- Presence of a malignant disease other than the one being treated in this study
Treatments
Darovasertib (DRUG)
Dosed orally, twice daily (28-day/ cycle
Primary Local Therapy (PROCEDURE)
Plaque Brachytherapy or Enucleation
Trial Sites (87)
Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, United States
Odette Houghton, MD Principal Investigator
Not Yet RecruitingUCSD Moores Cancer Center
La Jolla, California, United States
Gregory Daniels, MD Principal Investigator
Not Yet RecruitingJules Stein Eye Institute
Los Angeles, California, United States
Tara McCannel, MD Principal Investigator
Not Yet RecruitingUniversity of California Irvine Medical Center
Orange, California, United States
Poorva Vaidya, MD Principal Investigator
Not Yet RecruitingStanford Comprehensive Cancer Center
Palo Alto, California, United States
Pauline Funchain, MD Principal Investigator
Not Yet RecruitingKaiser Permanente-Riverside Medical Center
Riverside, California, United States
Helen Moon, MD Principal Investigator
Not Yet RecruitingUniversity of Colorado Hospital
Aurora, Colorado, United States
Sapna Patel, MD Principal Investigator
Not Yet RecruitingThe Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Ryan Weight, MD Principal Investigator
Not Yet RecruitingMayo Clinic Jacksonville
Jacksonville, Florida, United States
Bently Doonan, MD Principal Investigator
Not Yet RecruitingUSF Health Eye Institute
Tampa, Florida, United States
Jorge Agi, MD Principal Investigator
Not Yet RecruitingWilmer Eye Institute
Baltimore, Maryland, United States
James Handa, MD Principal Investigator
Not Yet RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
Kamaneh Montazeri, MD Principal Investigator
Not Yet RecruitingW Kellogg Eye Center
Ann Arbor, Michigan, United States
Hakan Demirci, MD Principal Investigator
Not Yet RecruitingThe Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, United States
Sreenivasa Chandana, MD Principal Investigator
RecruitingMayo Clinic - PPDS
Rochester, Minnesota, United States
Lauren Dalvin, MD Principal Investigator
Not Yet RecruitingTIERING Percentiles
Omaha, Nebraska, United States
Pukhraj Rishi, MD Principal Investigator
Not Yet RecruitingHerbert Irving Comprehensive Cancer Center
New York, New York, United States
WithdrawnMemorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, United States
Jasmine Francis, MD Principal Investigator
Not Yet RecruitingNorthwell Health Cancer Institute
New York, New York, United States
Shaheer Khan, MD Principal Investigator
Not Yet RecruitingCole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, United States
Lucy Kennedy, MD Principal Investigator
Not Yet RecruitingOhio State Eye and Ear Institute
Columbus, Ohio, United States
Colleen Cebulla, MD Principal Investigator
Not Yet RecruitingJefferson Health Honickman Center
Philadelphia, Pennsylvania, United States
Marlana Orloff, MD Principal Investigator
Not Yet RecruitingUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Yana Najjar, MD Principal Investigator
Not Yet RecruitingSoutheastern Retina Associates-Hixson
Hixson, Tennessee, United States
WithdrawnSCRI Oncology Partners
Nashville, Tennessee, United States
Meredith McKean, MD Principal Investigator
RecruitingAustin Retina Associates - Central
Austin, Texas, United States
Shelley Ghafoori, MD Principal Investigator
RecruitingTexas Retina Associates - Dallas
Dallas, Texas, United States
Timothy Fuller, MD Principal Investigator
RecruitingUniversity of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, United States
James Harbour, MD Principal Investigator
Not Yet RecruitingRetina Consultants of Texas - (Houston)
Houston, Texas, United States
Amy Schefler, MD Principal Investigator
Not Yet RecruitingAugusta Health, Center for Cancer and Blood Disorders
Fishersville, Virginia, United States
Kelvin Rayborn, MD Principal Investigator
Not Yet RecruitingUniversity of Wisconsin Health
Madison, Wisconsin, United States
Michael Altaweel, MD Principal Investigator
Not Yet RecruitingThe Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Rachel Roberts-Thomson, MD Principal Investigator
Not Yet RecruitingThe Alfred Hospital
Melbourne, Victoria, Australia
Mark Shackleton, MD Principal Investigator
Not Yet RecruitingLKH-Universitätsklinikum Graz
Graz, Austria
Thomas Georgi, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Innsbruck
Innsbruck, Austria
Matus Rehak, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum AKH Wien
Vienna, Austria
Roman Dunavölgyi, MD Principal Investigator
Not Yet RecruitingCliniques Universitaires Saint-Luc - PPDS
Brussels, Belgium
Jean-Francois Baurain, MD Principal Investigator
Not Yet RecruitingUZ Leuven - PPDS
Leuven, Belgium
Joachim Van Calster, MD Principal Investigator
Not Yet RecruitingPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
Marcus Butler, MD Principal Investigator
RecruitingUstredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
Prague, Prague, Czechia
Zuzana Hradcova, MD Principal Investigator
Not Yet RecruitingRigshospitalet
Copenhagen O, Capital, Denmark
Jens Kiilgaard, MD Principal Investigator
Not Yet RecruitingAarhus Universitetshospital
Aarhus, Central Jutland, Denmark
Peter Skov Jensen, MD Principal Investigator
Not Yet RecruitingEast Tallinn Central Hospital-Pärnu road 104
Tallinn, Harju, Estonia
Elen Vettus, MD Principal Investigator
Not Yet RecruitingCHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, France
Sacha Nahon-Estève, MD Principal Investigator
Not Yet RecruitingCentre Retine Gallien - Bordeaux
Bordeaux, Gironde, France
Laurence Rosier, MD Principal Investigator
Not Yet RecruitingCHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Frederic Mouriaux, MD Principal Investigator
Not Yet RecruitingInstitut Curie - Hôpital de Paris
Paris, Paris, France
Alexandre Matet, MD Principal Investigator
Not Yet RecruitingCentre Hospitalier National D'ophtalmologie Des Quinze Vingts
Paris, France
Sarah Tick, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Daniela Süsskind, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Armin Wolf, MD Principal Investigator
Not Yet RecruitingHautklinik Erlangen
Erlangen, Bavaria, Germany
Carola Berking, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Halime Kalkavan, MD Principal Investigator
Not Yet RecruitingStädtisches Klinikum Dessau
Dessau, Saxony-Anhalt, Germany
Lothar Krause, MD Principal Investigator
Not Yet RecruitingCharité - Universitätsmedizin Berlin
Berlin, Germany
Antonia Joussen, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Bonn
Bonn, Germany
Thomas Ach, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Svenja Sonntag, Principal Investigator, MD
Not Yet RecruitingUniversitätsklinikum Giessen und Marburg - Marburg (UKGM)
Marburg, Germany
Walter Sekundo, MD Principal Investigator
Not Yet RecruitingUniversitätsklinikum Würzburg
Würzburg, Germany
Andreas Berlin, MD Principal Investigator
Not Yet RecruitingPAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, Greece
Efstathios Detorakis, MD Principal Investigator
Not Yet RecruitingUniversity General Hospital of Larissa
Larissa, Larissa, Greece
Sofia Androudi, MD Principal Investigator
Not Yet RecruitingAHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, Greece
Konstantinos Boboridis, MD Principal Investigator
Not Yet RecruitingThe Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, Israel
Vicktoria Vishnevskia-Dai, MD Principal Investigator
RecruitingHadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Shahar Frenkel, MD Principal Investigator
RecruitingIstituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, Campania, Italy
Paolo Ascierto, MD Principal Investigator
Not Yet RecruitingASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Milan, Italy
Marco Pellegrini, MD Principal Investigator
Not Yet RecruitingAzienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Perugia, Perugia, Italy
Mario Mandalà, MD Principal Investigator
Not Yet RecruitingAzienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Cinzia Mazzini, MD Principal Investigator
Not Yet RecruitingAzienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
Pisa, Italy
Federica Genovesi Ebert, MD Principal Investigator
Not Yet RecruitingFondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Italy
Ernesto Rossi, MD Principal Investigator
Not Yet RecruitingErasmus MC
Rotterdam, South Holland, Netherlands
Emine Kiliç-Ciğirci, MD Principal Investigator
Not Yet RecruitingAuckland Eye
Auckland, Auckland, New Zealand
Riyaz Bhikoo, MD Principal Investigator
Not Yet RecruitingUniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2
Poznan, Greater Poland Voivodeship, Poland
Iwona Rospond-Kubiak, MD Principal Investigator
Not Yet RecruitingWIM-PIB, Centralny Szpital Kliniczny MON
Warsaw, Masovian Voivodeship, Poland
Izabela Nowak-Gospodarowicz, MD Principal Investigator
Not Yet RecruitingUniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk, Pomeranian Voivodeship, Poland
Kamil Drucis, MD Principal Investigator
Not Yet RecruitingFakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, Slovakia
Ladislav Janco, MD Principal Investigator
Not Yet RecruitingInstitute of Oncology Ljubljana
Ljubljana, Ljubljana, Slovenia
Janja Ocvirk, MD Principal Investiagtor
Not Yet RecruitingHospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
Maria José Blanco Teijeiro, MD Principal Investigator
Not Yet RecruitingHospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Jose Maria Caminal Mitjana, MD Principal Investigator
Not Yet RecruitingClinica Universidad Navarra
Pamplona, Navarre, Spain
Alfredo Garcia Layana, MD Principal Investigator
Not Yet RecruitingHospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, Spain
Rafael Martínez-Costa Pérez, MD Principal Investigator
Not Yet RecruitingHospital Clinico Universitario de Valladolid
Valladolid, Valladolid, Spain
Ciro Garcia-Alvarez, MD Principal Investigator
Not Yet RecruitingHospital Universitario Virgen Macarena
Seville, Spain
Francisco Espejo-Arjona, MD Principal Investigator
Not Yet RecruitingUniversitätsspital Basel
Basel, Switzerland
Alexandra Steinemann-Inauen, MD Principal Investigator
Not Yet RecruitingUniversitätsspital Zürich
Zurich, Switzerland
Egle Ramelyte, MD Principal Investigator
Not Yet RecruitingClatterbridge Cancer Centre - Liverpool - NWCRN - PPDS
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Joseph Sacco, MD Principal Investigator
Not Yet RecruitingUniversity College Hospital
London, United Kingdom
Heather Shaw, MD Principal Investigator
Not Yet RecruitingWeston Park Cancer Centre - PPDS
Sheffield, United Kingdom
Krishnakumar Garadi, MD Principal Investigator
Not Yet Recruiting