Charité - Universitätsmedizin Berlin 12203 Berlin (Berlin) GermanyRekrutierend» Google-Maps Ansprechpartner: Julia Koester-Schuster Phone: 4930450554388 E-Mail: studien-augenklinik-cbf@charite.de» Ansprechpartner anzeigenUniversity Hospital Essen - West German Cancer Center 45147 Essen (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-MapsHonorHealth Research Institute 85258 Scottsdale United StatesRekrutierend» Google-Maps Ansprechpartner:
Moores Cancer Center 92093 La Jolla United StatesRekrutierend» Google-Maps Ansprechpartner: Catherine O'Neil Phone: 858-822-6575 E-Mail: croneil@health.ucsd.edu
Jazelle Molina Phone: (858) 822-5354 E-Mail: jgmolina@health.ucsd.edu» Ansprechpartner anzeigenUCLA Medical Center 90024 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Adyel Annelus Phone: 310-794-4955 E-Mail: aannelus@mednet.ucla.edu
Elizabeth Seja Phone: 310-794-6892 E-Mail: eseja@mednet.ucla.edu» Ansprechpartner anzeigenStanford Cancer Institute 94305 Palo Alto United StatesRekrutierend» Google-Maps Ansprechpartner: Claire A Billman, B.S Phone: 650-736-6425 E-Mail: cbillman@stanford.edu
Denise Haas, MBA Phone: 650-736-1252 E-Mail: dhaas@stanford.edu» Ansprechpartner anzeigenSarah Cannon Research Institute 80218 Denver United StatesRekrutierend» Google-Maps Ansprechpartner: Sarah Cannon Phone: 720-754-2610 E-Mail: cann.ddudenvergeneral@sarahcannon.com» Ansprechpartner anzeigenUniversity of Miami 33146 Miami United StatesRekrutierend» Google-Maps Ansprechpartner: Clinical Trials Group E-Mail: CRSCutaneous@miami.edu» Ansprechpartner anzeigenThe Cancer and Hematology Centers 49546 Grand Rapids United StatesRekrutierend» Google-Maps Ansprechpartner: The Cancer and Hematology Centers of Western Michigan Phone: 616-954-5550 E-Mail: ClinicalTrials@chcwm.com
Jessica Miller, RN Phone: 616-954-5550 Phone (ext.): 1651 E-Mail: jmiller@chcwm.com» Ansprechpartner anzeigenMayo Clinic Rochester 55905 Rochester United StatesRekrutierend» Google-Maps Ansprechpartner: Clinical Trials Referral Office Phone: 855-776-0015 E-Mail: mayocliniccancerstudies@mayo.edu» Ansprechpartner anzeigenNorthwell 11030 Manhasset United StatesRekrutierend» Google-Maps Ansprechpartner: Leila Nasr, BS Phone: 646-785-8203 E-Mail: lnasr@northwell.edu» Ansprechpartner anzeigenDuke University Health System 27710 Durham United StatesRekrutierend» Google-Maps Ansprechpartner: Carol Ann Wiggs, BSN Phone: 919-684-0281 E-Mail: carolann.wiggs@duke.edu
Emily Bolch Phone: 919-668-6359 E-Mail: emily.bolch@duke.edu» Ansprechpartner anzeigenThomas Jefferson University 19107 Philadelphia United StatesRekrutierend» Google-Maps Ansprechpartner: Marlana Orloff, MD Phone: 215-955-9980 E-Mail: Marlana.Orloff@Jefferson.edu
Liam Hulse, BS Phone: 215-520-5206 E-Mail: liam.hulse@jefferson.edu» Ansprechpartner anzeigenSarah Cannon Research Institute 37203 Nashville United StatesRekrutierend» Google-Maps Ansprechpartner: Ask Sarah Phone: 844-482-4812» Ansprechpartner anzeigenUniversity of Texas Southwestern Medical Center 75390 Dallas United StatesRekrutierend» Google-Maps Ansprechpartner: James Harbour, MD Phone: 214-648-3407 E-Mail: William.Harbour@UTSouthwestern.edu
Juan Mo, PhD Phone: (214) 645-3087 E-Mail: Juan.Mo@UTSouthwestern.edu» Ansprechpartner anzeigenSt. Vincent's Health Sydney 2010 Sydney AustraliaRekrutierend» Google-Maps Ansprechpartner:
Phone: 02 9355 5611 E-Mail: SVHS.CancerResearch@svha.org.au» Ansprechpartner anzeigenAlfred Health 3004 Melbourne AustraliaRekrutierend» Google-Maps Ansprechpartner: Chris Brooks E-Mail: chr.brooks@alfred.org.au» Ansprechpartner anzeigenPrincess Margaret Cancer Centre M5G2M9 Toronto CanadaRekrutierend» Google-Maps Ansprechpartner: Melissa Dalva Phone: 416-946-4501 Phone (ext.): 5485 E-Mail: Melissa.Dalva@uhn.ca» Ansprechpartner anzeigenInstitute Curie 75005 Paris FranceRekrutierend» Google-Maps Ansprechpartner: Sophie Piperno-Neumann, MD Phone: +33(0)1 44 32 40 68 E-Mail: sophie.piperno-neumann@curie.fr» Ansprechpartner anzeigenInstituto Nazionale Tumori di Milano 20133 Milano ItalyNoch nicht rekrutierend» Google-MapsInstituto Nazionale Tumori IRCCS - Fondazione Pascale 80131 Napoli ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner:
E-Mail: melanoma.immunoterapia@istitutotumori.na.it» Ansprechpartner anzeigenFondazione Policlinico Universitario Agostino Gemelli IRCCS 00168 Rome ItalyRekrutierend» Google-Maps Ansprechpartner: Ernesto Rossi E-Mail: oncomedsperimentali@policlinicogemelli.it» Ansprechpartner anzeigenLeiden University Medical Center 2333 ZA Leiden NetherlandsRekrutierend» Google-Maps Ansprechpartner: Ellen Kapiteijn, MD, PhD Phone: 0031 71 5261093 E-Mail: H.W.Kapiteijn@lumc.nl» Ansprechpartner anzeigenUniversity College London Hospital - NHS Foundation Trust NW1 2PG London United KingdomNoch nicht rekrutierend» Google-Maps Ansprechpartner: Heather Shaw Phone: 0203 447 5369 E-Mail: uclh.randd@nhs.net» Ansprechpartner anzeigenThe Clatterbridge Cancer Centre NHS Foundation Trust CH63 4JY Wirral United KingdomNoch nicht rekrutierend» Google-Maps Ansprechpartner: Joseph Sacco Phone: 0151 556 5212 E-Mail: j.j.sacco@liverpool.ac.uk» Ansprechpartner anzeigen
1. Incidence of Adverse Events (AEs) and significant laboratory abnormalities (Time Frame - from first dose to last dose of adjuvant therapy, approximately 12 months): 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.
2. Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation (Time Frame - from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months): Rate of eye salvage as determined by the ocular oncologist based on tumor response to
neoadjuvant therapy
3. Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose (Time Frame - from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months): Change in modeled radiation dose at critical eye structures before and after neoadjuvant
therapy
Secondary outcome:
1. Evaluate tumor response to neoadjuvant IDE196 (Time Frame - from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months): 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)
2. Assessment of visual acuity loss (Time Frame - from time of primary local therapy to one year after surgery, approximately 12 months): Best corrected visual acuity loss over time
3. Rate of local disease recurrence (Time Frame - from date of primary local therapy to end of follow-up, approximately 36 months): Evaluate uveal melanoma progression or recurrence
4. Rate of metastatic disease (Time Frame - from date of primary local therapy to end of follow-up, approximately 36 months): Evaluate occurrence of metastatic uveal melanoma
