Neoadjuvant Darovasertib in Primary Uveal Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Darovasertib, Primary Local Therapy.
- Who it may be relevant to
- Registry conditions: Uveal Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Belgium, Canada +16
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
Overview
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Detailed description
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.
Interventions
- Drug Darovasertib
Dosed orally, twice daily (28-day/ cycle - Procedure Primary Local Therapy
Plaque Brachytherapy or Enucleation
Primary outcome measures
- Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm [Time frame: Approximately 3 years]
- Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm [Time frame: Approximately 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 35 centers
- Mayo Clinic Scottsdale - PPDS — Scottsdale
- UCSD Moores Cancer Center — La Jolla
- Jules Stein Eye Institute — Los Angeles
- USC Norris Comprehensive Cancer Center — Los Angeles
- University of California Irvine Medical Center — Orange
- Stanford Comprehensive Cancer Center — Palo Alto
- Kaiser Permanente-Riverside Medical Center — Riverside
- UCSF Wayne and Gladys Valley Center for Vision — San Francisco
- … and 27 more centers
Germany · 10 centers
- Universitätsklinikum Tübingen — Tübingen
- Universitätsklinikum Ulm — Ulm
- Hautklinik Erlangen — Erlangen
- Universitätsklinikum Essen — Essen
- Städtisches Klinikum Dessau — Dessau
- Charité - Universitätsmedizin Berlin — Berlin
- Universitätsklinikum Bonn — Bonn
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck — Lübeck
- … and 2 more centers
Italy · 6 centers
- Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale — Naples
- ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco — Milan
- Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia — Perugia
- Azienda Ospedaliera Universitaria Careggi — Florence
- Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia — Pisa
- Fondazione Policlinico Universitario A Gemelli - Rome - PPDS — Rome
Spain · 6 centers
Center list to be confirmed — check the primary protocol.
France · 5 centers
- CHU de Nice-Hôpital Pasteur — Nice
- Centre Retine Gallien - Bordeaux — Bordeaux
- CHU de Rennes - Hôpital Pontchaillou — Rennes
- Institut Curie - Hôpital de Paris — Paris
- Centre Hospitalier National D'ophtalmologie Des Quinze Vingts — Paris
Australia · 4 centers
- Gallipoli Medical Research Foundation — Greenslopes
- The Queen Elizabeth Hospital — Woodville South
- The Alfred Hospital — Melbourne
- The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214 — Westmead
Austria · 3 centers
- LKH-Universitätsklinikum Graz — Graz
- Universitätsklinikum Innsbruck — Innsbruck
- Universitätsklinikum AKH Wien — Vienna
Greece · 3 centers
- PAGNI-University General Hospital of Heraklion — Heraklion
- University General Hospital of Larissa — Larissa
- AHEPA University General Hospital of Thessaloniki — Thessaloniki
Poland · 3 centers
- Uniwersytecki Szpital Kliniczny w Poznaniu- Dluga 1/2 — Poznan
- WIM-PIB, Centralny Szpital Kliniczny MON — Warsaw
- … and 1 more center
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Belgium · 2 centers
- Cliniques Universitaires Saint-Luc - PPDS — Brussels
- UZ Leuven - PPDS — Leuven
Canada · 2 centers
- Cross Cancer Institute — Edmonton
- Princess Margaret Cancer Centre — Toronto
Denmark · 2 centers
- Rigshospitalet — Copenhagen O
- Aarhus Universitetshospital — Aarhus
Israel · 2 centers
- The Chaim Sheba Medical Center - PPDS — Ramat Gan
- Hadassah Medical Center - PPDS — Jerusalem
Switzerland · 2 centers
Center list to be confirmed — check the primary protocol.
Czechia · 1 center
- Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha — Prague
Estonia · 1 center
- East Tallinn Central Hospital-Pärnu road 104 — Tallinn
Netherlands · 1 center
- Erasmus MC — Rotterdam
New Zealand · 1 center
- Auckland Eye — Auckland
Slovakia · 1 center
Center list to be confirmed — check the primary protocol.
Slovenia · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07015190 · IDE196-010