Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305767
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-05
Brief Title:
A Clinical Study of V940 Treatment and Pembrolizumab in People With Bladder Cancer V940-005INTerpath-005
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 12 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma MIUC INTerpath-005
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma MIUC Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract such as part of the kidneys ureters and urethra People with MIUC usually have chemotherapy before surgery then surgery to remove the cancer Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing After surgery some people receive more treatment to prevent cancer from returning Pembrolizumab is an immunotherapy which is a treatment that helps the immune system fight cancer Enfortumab vedotin EV is an antibody drug conjugate ADC An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells Researchers want to learn if giving V940 the study treatment with pembrolizumab can prevent MIUC from returning after surgery V940 also called mRNA-4157 is designed to treat each persons cancer by helping the persons immune system identify and kill cancer cells based on certain proteins found on those cancer cells
The goals of this study are to learn if people who receive V940 and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab and to learn about the safety of V940 pembrolizumab and EV and if people tolerate them
The goals of this study are to learn if people who receive V940 and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab and to learn about the safety of V940 pembrolizumab and EV and if people tolerate them
Detailed Description:
Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned to start in approximately February of 2025
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| V940-005 | OTHER | None | None |
| U1111-1292-1952 | OTHER | None | None |
| 2023-505658-17 | OTHER | EU CT | None |