Spots Global Cancer Trial Database for A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
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Trial Identification
Brief Title: A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
Official Title: A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
Study ID: NCT06365853
Study Description
Brief Summary: The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression.
Detailed Description: Participants will be randomized (1:1) to 1 of 2 ocular adverse event (AE) risk mitigation strategy arms (primary prophylactic steroid eye drops versus primary prophylactic vasoconstricting eye drops).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP), Aurora, Colorado, United States
Yale School of Medicine - Yale Gynecologic Oncology, New Haven, Connecticut, United States
Holy Cross Hospital, Silver Spring, Maryland, United States
Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology, Springfield, Massachusetts, United States
New York Oncology Hematology, Albany, New York, United States
Women's Cancer Care Associates, LLC, Albany, New York, United States
New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion, New York, New York, United States
Duke Cancer Institute (DCI) - Duke Cancer Center, Durham, North Carolina, United States
University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic, Dallas, Texas, United States
Monash University - Monash Medical Centre (MMC) - Clayton, Clayton, Victoria, Australia
Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek, Edegem, Antwerp, Belgium
AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek, Gent, East Flanders, Belgium
Universitair Ziekenhuis Gent (UZ Gent), Gent, East Flanders, Belgium
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre, Montreal, Quebec, Canada
Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame, Montreal, Quebec, Canada
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin, Paris, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon, Paris, , France
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud, Pierre Benite, , France
Bon Secours Hospital - Dublin, Dublin, , Ireland
Mater Misericordiae University Hospital (MMUH) (START Dublin), Dublin, , Ireland
Istituto Europeo di Oncologia (IEO) (European Institute of Oncology), Milan, , Italy
Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location, Badalona, Barcelona, Spain
Parc Taulí, Barcelona, , Spain
Vall d'Hebron Institut d'Oncologia, Barcelona, , Spain
Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen), Jaen, , Spain
Contact Details
Name: Sheri Spunt, MD
Affiliation: ImmunoGen, Inc.
Role: STUDY_DIRECTOR
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