GS-US-682-6769_GOG - 3104_ENGOT-en26: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physicians Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
Sponsor: |
Gilead Sciences, Inc and GOG Partners |
Enrolling: |
Female Patients Only |
Study Length: |
2 Years |
Clinic Visits: |
12 |
IRB Number: |
AAAV3402 |
U.S. Govt. ID: |
NCT06486441 |
Contact: |
Reena Vattakalam, MPA, CCRP: 212-342-6895 / rmv2110@cumc.columbia.edu |
The purpose of this research study is to learn if sacituzumab govitecan (also called SG) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel). Sacituzumab govitecan is a type of drug called an antibody-drug conjugate. An antibody-drug conjugate (ADC) is a cancer treatment that combines a monoclonal antibody (mAb) with a drug to deliver chemotherapy directly to cancer cells. Antibodies are proteins normally made by the immune system. The antibody part attaches to a certain type of protein called Trop-2, which is found in many cancers including endometrial cancer, to release the anti-cancer drug part to target and kill cancer cells. SG is not approved by the FDA. Doxorubicin and paclitaxel are each approved by the Food and Drug Administration (FDA) in the US for the treatment of several types of cancer. Doxorubicin and paclitaxel have not been formally approved by the FDA in the US for this use.
Investigator
Jason Wright, MD
Are you 18 or older? |
Yes |
No |
Do you have a confirmed diagnosis of recurrent endometrial cancer? |
Yes |
No |
Have you relapsed after 1-3 prior lines of therapy like carboplatin? |
Yes |
No |