Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04724018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-07
First Post:
2021-01-20
Brief Title:
Sacituzumab Govitecan Plus EV in Metastatic UC
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Sacituzumab Govitecan Plus Enfortumab Vedotin for Metastatic Urothelial Carcinoma Progressing on Platinum-based Chemotherapy and PD1L1 Inhibitors the Double Antibody Drug Conjugate DAD Phase I Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Enfortumab Vedotin
Sacituzumab Govitecan
The names of the study drugs in this investigational combination are
Enfortumab Vedotin
Sacituzumab Govitecan
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 PD1L1 inhibitors
The US 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 PD1L1 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 someones 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
The US 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 PD1L1 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 someones 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None