MER-XMT-1536-3/ GOG 3049: : A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-PlatinumMaintenance Therapy for Participants with Recurrent, Platinum-Sensitive OvarianCancer (UP-NEXT)
Study of Upifitamab Rilsodotin (XMT-1536) in Patients with Recurrent Ovarian Cancer
Sponsor: Mersana Therapeutics and GOG foundation
Enrolling: Male and Female Patients
IRB Number: AAAU0810
U.S. Govt. ID: NCT05329545
Contact: Reena Vattakalam: 212-342-6895 / rmv2110@cumc.columbia.edu
Additional Study Information: XMT-1536 (upifitamab rilsodotin) is a targeted therapy, which means that it is directed specifically at a tumor. It is a type of antibody-drug conjugate; this means it has 2 parts that are joined together into one drug. The first part is an antibody that binds to NaPi2b (sodium-dependent phosphate transporter), a protein on the surface of the cells of your tumor. The second part is a cancer medicine that is attached to the antibody. When the antibody binds to NaPi2b, it carries the cancer medicine directly into the tumor cells to kill them. XMT-1536 is the study drug and a placebo is an inactive drug or treatment used in a clinical trial. Subjects will be randomized and blinded into the two groups after you finish your treatment with carboplatin and taxol. A computer will decide which group you are put in. You have an equal chance of getting XMT-1536 or placebo. You, your study doctor, and the study staff won't know whether you are getting XMT-1536 or placebo. In case of a health emergency, they can find out. The purpose of the study is to compare progression-free survival (the length of time that participants live without their disease getting worse) for participants with ovarian cancer with high NaPi2b level on their tumor cells treated with XMT-1536 versus placebo following standard chemotherapy, compare response to treatment and overall survival, compare safety and tolerability of treatment with XMT-1536 versus treatment with placebo, compare the time to the start of next cancer treatment after study treatment with XMT-1536 or placebo and the time to worsening of participants cancers following next cancer treatment, understand quality of life through participant questionnaires, and evaluate if blood levels of XMT-1536 and proteins your body may produce that can bind to XMT-1536 are related to response to treatment or side effects of treatment.
This study is closed
Investigator
Jason Wright, MD
Do You Qualify?
Have you been diagnosed with ovarian, fallopian tube or primary peritoneal cancer that has worsened/come back after treatment? Yes No
Do you have tissue available from previous surgery or willing to undergo biopsy to obtain tumor tissue? Yes No
Do you have at least one measurable lesion on scans? Yes No
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You may be eligible for this study

Place Holder




For more information, please contact:
Reena Vattakalam
rmv2110@cumc.columbia.edu
212-342-6895