Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04724018
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sacituzumab Govitecan Plus EV in Metastatic UC
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Combinations of Sacituzumab Govitecan Plus Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Carcinoma: the Double Antibody Drug Conjugate (DAD) and Double Antibody Drug Conjugate With Immunotherapy (DAD-IO) Phase I/II Trial
Status:
RECRUITING
Status Verified Date:
2025-11
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:
Phase I of 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). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination.
The names of the study drugs in these investigational combinations are:
* Enfortumab Vedotin
* Sacituzumab Govitecan
* Pembrolizumab
The names of the study drugs in these investigational combinations are:
* Enfortumab Vedotin
* Sacituzumab Govitecan
* Pembrolizumab
Detailed Description:
Phase I of this study was 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 expand to a phase 2 trial looking how effective (how well the drug works)the combination in slowing down the growth of metastatic urothelial carcinoma (mUC) progressing on platinum-based chemotherapy and PD1/L1 inhibitors and in combination with PD1/PDL1 inhibitors in treatment naive disease.
Phase II of this study is a multicenter phase 2 trial to to test the efficacy of Sacituzumab Govitecan in combination with Enfortumab Vedotin in patients with treatment refractory urothelial carcinoma (Cohort A). Phase II will also study the efficacy of the combination of Enfortumab Vedotin, Sacituzumab Govitecan, and Pembrolizumab in patients who have not yet received systemic therapy for metastatic carcinoma and are more than 6 months from completion of any immunotherapy in the perioperative setting (Cohort B).
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.
Gilea, 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 Phase I of this research study and up to 41 people will take part in each of the two Phase II cohorts.
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 expand to a phase 2 trial looking how effective (how well the drug works)the combination in slowing down the growth of metastatic urothelial carcinoma (mUC) progressing on platinum-based chemotherapy and PD1/L1 inhibitors and in combination with PD1/PDL1 inhibitors in treatment naive disease.
Phase II of this study is a multicenter phase 2 trial to to test the efficacy of Sacituzumab Govitecan in combination with Enfortumab Vedotin in patients with treatment refractory urothelial carcinoma (Cohort A). Phase II will also study the efficacy of the combination of Enfortumab Vedotin, Sacituzumab Govitecan, and Pembrolizumab in patients who have not yet received systemic therapy for metastatic carcinoma and are more than 6 months from completion of any immunotherapy in the perioperative setting (Cohort B).
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.
Gilea, 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 Phase I of this research study and up to 41 people will take part in each of the two Phase II cohorts.
Study Oversight
Has Oversight DMC:
True
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?: