Spots Global Cancer Trial Database for REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
Official Title: REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)
Study ID: NCT05870748
Study Description
Brief Summary: A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.
Detailed Description: This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1. Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen. Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy. Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arizona Oncology Associates, PC-Hope, Tucson, Arizona, United States
Sutter Health, Daly City, California, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Baptist Health South Florida (BHSF) - Miami Cancer Institute, Miami, Florida, United States
USF Research & Innovation, Tampa, Florida, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States
Minnesota Oncology Hematology, Minneapolis, Minnesota, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Optimum Clinical Research Group, Albuquerque, New Mexico, United States
NYU Langone Health, New York, New York, United States
Good Samaritan Hospital Medical Center, West Islip, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Ohio State University Center, Columbus, Ohio, United States
Kettering Health, Kettering, Ohio, United States
Oklahoma Cancer Specialists and Research Institute- Tulsa Cancer Center, Tulsa, Oklahoma, United States
Oncology Associates of Oregon, PC, Eugene, Oregon, United States
Providence Gynecologic Oncology Clinic, Portland, Oregon, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Texas Oncology, Dallas, Texas, United States
Texas Oncology-DFW, Dallas, Texas, United States
Texas Oncology-San Antonio, San Antonio, Texas, United States
Texas Oncology - The Woodlands, The Woodlands, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
McGill University Health Centere (MUHC)-Glen Site, Montréal, Quebec, Canada
Princess Margaret Cancer Center, Toronto, , Canada
Sheba Medical Center, Ramat Gan, , Israel
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Yonsei University, Severance Hospital, Seoul, , Korea, Republic of
Curie Centre, Oncology centre, Novena, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
