IMMU-132 versus chemotherapy in metastatic or locally advanced UC
Research type
Research Study
Full title
A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer
IRAS ID
1003505
Contact name
Diane Whiteley
Sponsor organisation
Immunomedics, Inc.
Eudract number
2020-002964-29
Clinicaltrials.gov Identifier
Research summary
This study is researching a potential new medication called sacituzumab govitecan to determine if it is safe and effective in controlling urothelial cancer because earlier studies of this study medication have shown that patients with urothelial cancer treated with this drug have responded to it. This study is being investigated in metastatic or locally advanced unresectable (cannot be removed surgically) urothelial (urinary system) cancer that has progressed after having received previous treatment with platinum-based chemotherapy (e.g. cisplatin or carboplatin) and immunotherapy.
Sacituzumab govitecan is composed of a drug attached to an antibody. The drug is the active ingredient of irinotecan. Irinotecan is a type of chemotherapy that has been approved to treat colon and rectal cancer. Antibodies are proteins normally made by the immune system. The antibody in this medication binds to a protein that is present on cancer cells including urothelial cancer cells. The study is being conducted to determine if sacituzumab govitecan is better than standard of care (SoC) chemotherapy in controlling metastatic or locally advanced unresectable urothelial cancer. The 3 SoC options that will be used in this study are, paclitaxel, docetaxel, and vinflunine.
The main purpose of this study is to determine whether treatment with sacituzumab govitecan can improve survival (the amount of time you live) in patients with metastatic or locally advanced unresectable urothelial cancer who have already received platinum-containing chemotherapy (e.g. cisplatin or carboplatin) and immunotherapy. Information on overall safety, clinical benefit and quality of life, and other basic information and supporting data, will also be collected during the study.
This is a randomised (50% chance that you will receive either study medication or SoC treatment) open-label phase III study. Approximately 600 participants, who are 18 years and older will be enrolled in this study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0078
Date of REC Opinion
19 May 2021
REC opinion
Further Information Favourable Opinion