Sacituzumab Govitecan Plus EV in Metastatic UC
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ClinicalTrials.gov Identifier: NCT04724018 |
Recruitment Status :
Active, not recruiting
First Posted : January 26, 2021
Last Update Posted : November 7, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 20, 2021 | ||||||||||||||
First Posted Date ICMJE | January 26, 2021 | ||||||||||||||
Last Update Posted Date | November 7, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | May 20, 2021 | ||||||||||||||
Estimated Primary Completion Date | October 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Sacituzumab Govitecan Plus EV in Metastatic UC | ||||||||||||||
Official Title ICMJE | Sacituzumab Govitecan Plus Enfortumab Vedotin for Metastatic Urothelial Carcinoma Progressing on Platinum-based Chemotherapy and PD1/L1 Inhibitors: the Double Antibody Drug Conjugate (DAD) Phase I Trial | ||||||||||||||
Brief Summary | This research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). The names of the study drugs in this investigational combination are:
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Detailed Description | This study is a single-center, open-label, nonrandomized phase I trial testing the safety and efficacy as well as defining the appropriate dose for future studies of Sacituzumab Govitecan and Enfortumab for people with metastatic urothelial carcinoma (mUC) progressing on platinum-based chemotherapy and PD1/L1 inhibitors The U.S. Food and Drug Administration (FDA) has approved Enfortumab Vedotin for the treatment of metastatic urothelial carcinoma (mUC) (bladder cancer). The FDA has not approved Sacituzumab Govitecan for metastatic urothelial carcinoma (mUC) (bladder cancer) but it has been approved for other uses. The FDA has approved Sacituzumab Govitecan to treat a type of breast cancer at this time. Sacituzumab Govitecan has appeared promising in patients with bladder cancer that has spread and works by a different mechanism than Enfortumab Vedotin. Therefore, the researchers believe that combining these 2 drugs may control the cancer better than each drug does on its own. This will be done through testing different combinations and checking for serious side effects; if there are no serious side effects a different dose combination will be explored. Once the best combination has been determined, the study will look to see how effective (how well the drug works) it is in slowing down the growth of metastatic urothelial carcinoma (mUC) progressing on platinum-based chemotherapy and PD1/L1 inhibitors and define the most appropriate level of the drugs to use for further studies. The research study procedures include screening for eligibility, study treatment, and safety follow-up visits, in addition to general health status follow-up after study treatment. Participants will receive study treatment for as long as they do not have serious side effects and their disease does not get worse. However, the duration may vary depending on how long the treatment works to control the cancer and how someone's body tolerates the side effects. Immunomedics, a pharmaceutical company, is supporting this research study by providing funding for the research study, tests required for research purposes only, and the study drug Sacituzumab Govitecan. It is expected that up to 24 people will take part in this research study. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Dose Escalation Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV),
Participants will be given the study drugs Enfortumab Vedotin and then Sacituzumab Govitecan on Days 1 and 8 of a 21-day study cycle. Dose escalation and de-escalation for the Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination will be guided using the Bayesian optimal interval (BOIN) design with up to 4 dose level escalations.
Interventions:
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
24 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | May 1, 2026 | ||||||||||||||
Estimated Primary Completion Date | October 1, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Patients with locally advanced unresectable disease are eligible.
Exclusion Criteria: Subjects meeting any of the following exclusion criteria at Screening/Day 1 of treatment will not be enrolled in the study.
All subjects with carcinomatous meningitis are excluded regardless of clinical stability.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04724018 | ||||||||||||||
Other Study ID Numbers ICMJE | 20-614 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Bradley A. McGregor, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Guru P. Sonpavde, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Gilead Sciences | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | November 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |