Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT03773666
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2018-12-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Feasibility Study of Durvalumab (MEDI4736) Alone or in Combination With Oleclumab (MEDI9447) as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)
Status:
COMPLETED
Status Verified Date:
2022-09
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 is studying a new anti-cancer drug durvalumab (MEDI4736) with or without another new anti-cancer drug Oleclumab (MEDI9447) before surgery for bladder cancer.
The drugs involved in this study are:
* Durvalumab (MEDI4736)
* Oleclumab (MEDI9447)
The drugs involved in this study are:
* Durvalumab (MEDI4736)
* Oleclumab (MEDI9447)
Detailed Description:
This research study is a Feasibility Study, which is the first time investigators are examining these drugs, Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in patients with muscle-invasive bladder cancer (MIBC) cancer prior to surgery. Cisplatin-containing chemotherapy given before surgery is the standard of care in patients with MIBC because it increases the rate of cure after surgery. Participants may still be eligible for this study if their doctor determines that participants are able to receive cisplatin-containing chemotherapy, but the participants elect not to undergo chemotherapy before surgery, understanding the potential benefits of chemotherapy. The FDA (the U.S. Food and Drug Administration) has not approved Durvalumab (MEDI4736) for localized bladder cancer prior to surgery, but it has been approved for other uses, including for locally advanced or metastatic bladder cancer after progression on platinum-containing chemotherapy. The FDA (the U.S. Food and Drug Administration) has not approved Oleclumab (MEDI9447) as a treatment for any disease. Durvalumab is a monoclonal antibody (an antibody is a protein produced by the body's immune system) that works by blocking the Programmed Cell Death Ligand 1 (PD-L1), a protein on cancer cells that stops the body's immune system from killing cancer cells, to increase the body's immune response to prevent or slow down cancer growth. Oleclumab is a monoclonal antibody that works by reducing the amount of adenosine, a small molecule called a metabolite that binds to adenosine receptors on immune cells to regulate the immune system and suppress the immune response. Reducing the amount of immunosuppressive adenosine can increase the body's immune response to kill cancer cells. It is hoped that by combining Oleclumab with Durvalumab, an even greater immune response against the tumor will be generated. This research study is designed to see if the new anti-cancer drug Durvalumab (MEDI4736) with or without another new anti-cancer drug Oleclumab (MEDI9447) can be safely administered before surgery for bladder cancer
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?: