GOG-3133 Lilly FRAmework-01 - J5E-MC-JZXB

What is the Purpose of this Study?

If you join this study, you will first go through screening to make sure the study is a good fit for you. After that, you will receive treatment and be followed over time. People are placed into treatment groups by chance and will get either a study medicine or a usual cancer treatment. The study has two parts. One part is for people whose cancer does not respond to platinum medicine, and the other part is for people whose cancer still responds to platinum medicine. Treatments are given through a vein, usually once every three weeks. During the study, you will go to regular clinic visits for checkups, blood tests, scans, and safety checks. Treatment will continue as long as it helps and the side effects stay manageable.

What is the Condition Being Studied?

This study is for people who have advanced ovarian cancer. The cancer may be in the ovaries, fallopian tubes, or the lining inside the belly. Some people in the study have cancer that still responds to a medicine called platinum, and some have cancer that no longer responds to it. The study is testing different treatments to see which ones work best for these types of ovarian cancer.

Who Can Participate in the Study?

People can join this study if they are 18 years old or older and have a serious type of ovarian cancer. The cancer can be in the ovaries, fallopian tubes, or the lining inside the belly. The cancer must be high grade and either not responding to platinum medicine or returning after platinum treatment and another cancer treatment. Participants must have received some cancer treatments before joining. They also need to be in fairly good health and able to do most daily activities on their own.

Age Group
Adults

What is Involved?

This study is being done to see if a new medicine called sofetabart mipitecan can help women with advanced ovarian cancer live longer without their cancer getting worse. Researchers will compare this new medicine to standard treatments to find out which one works better.

Study Details

Full Title
FRAmework-01: A Two-Part Phase 3 Study of LY4170156 versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer
Principal Investigator
Professor of Obstetrics and Gynecology
Protocol Number
IRB: PRO00119658
NCT: NCT07213804
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF