Spots Global Cancer Trial Database for Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
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Trial Identification
Brief Title: Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants With Recurrent, Platinum-Sensitive, Ovarian Cancer (UP-NEXT)
Study ID: NCT05329545
Study Description
Brief Summary: UP-NEXT is a double-blind, randomized, placebo-controlled study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC), including fallopian tube and primary peritoneal cancer, expressing high levels of NaPi2b.
Detailed Description: This is a multi-center randomized study of XMT-1536 (upifitamab rilsodotin) in patients with tumors expressing high levels of NaPi2b, focusing on patients with recurrent, platinum-sensitive high-grade serous ovarian cancer (HGSOC) including fallopian tube and primary peritoneal cancer. The randomized study design is a double-blind, placebo-controlled study, with a randomization ratio of 2:1. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Participants must have had 4 to 8 cycles of platinum-based chemotherapy in their most recent treatment regimen, including carboplatin or cisplatin ± paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine in the 2nd-4th line setting for the treatment of platinum-sensitive recurrent disease, with no evidence of disease (NED)/complete response (CR)/partial response (PR)/ or stable disease (SD) as best response.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
HonorHealth Research Institute - HonorHealth VGPCC Biltmore, Phoenix, Arizona, United States
The University of Arizona Cancer Center, Tucson, Arizona, United States
University of California Los Angeles, Gynecologic Oncology Clinic, Los Angeles, California, United States
University of California, Irvine Medical Center, Orange, California, United States
Sarasota Memorial Hospital, Sarasota, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
WK Physicians, Shreveport, Louisiana, United States
Karmanos Cancer Institute - Detroit, Detroit, Michigan, United States
Billings Clinic, Billings, Montana, United States
Methodist Hospital, Omaha, Nebraska, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Center of Hope, Reno, Nevada, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Southwest Women's Oncology, Albuquerque, New Mexico, United States
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland, Ohio, United States
Kettering Health Cancer Center, Kettering, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Legacy Good Samaritan Medical Center - Legacy Medical Group - Gynecologic Oncology, Portland, Oregon, United States
Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States
Sanford Gynecologic Oncology, Sioux Falls, South Dakota, United States
Avera McKennan d/b/a Avera Research Institute, Sioux Falls, South Dakota, United States
Texas Oncology P.A. - Austin, Austin, Texas, United States
Texas Oncology - DFWW, Bedford, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
VCU Massey Cancer Center, Richmond, Virginia, United States
University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Epworth Richmond, Richmond, Victoria, Australia
Sherbrooke University Hospital Centre, Quebec, Sherbrooke, Canada
Contact Details
Name: Robert Burger, MD
Affiliation: Mersana Therapeutics
Role: STUDY_DIRECTOR
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