Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-09 @ 5:33 AM
Study NCT ID:
NCT02925533
Status:
TERMINATED
Last Update Posted:
2017-06-27
First Post:
2016-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph 1B B-701 in Combination With Pembrolizumab in Metastatic Transitional Cell Carcinoma of the Urothelial Tract
Sponsor:
Mark Pomerantz, MD
Organization:
Study Overview
Official Title:
A Phase 1B Study of B-701 in Combination With Pembrolizumab in Relapsed or Refractory Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to safety concerns.
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 combination of two experimental drugs as a possible treatment for Bladder Cancer that recurred after treatment with standard therapy, or Bladder Cancer that got worse while on treatment with standard therapy.
The following interventions will be involved in this study:
* B-701
* Pembrolizumab
The following interventions will be involved in this study:
* B-701
* Pembrolizumab
Detailed Description:
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved B-701 as a treatment for any disease.
The FDA has not approved Pembrolizumab for Bladder Cancer but it has been approved for other uses.
This is the first time that B-701 in combination with Pembrolizumab will be given to humans.
In this research study, Investigators are...
* Testing the effectiveness and safety of the combination of two experimental drugs (B-701 and Pembrolizumab);
* Learning about the good and/or bad effects the drugs have on participants and their cancer;
* Administering B-701 and Pembrolizumab, which are antibodies (proteins that bind to other molecules), because...
* B-701 binds to a protein receptor called FGFR3 (fibroblast growth factor receptor 3). FGFR3 has been found to be present (expressed) or changed (mutated) on the surface of in many types of cancer cells. Targeting FGFR3 may inhibit cancer growth.
* Pembrolizumab binds to a protein cell surface receptor called PD-1, which is found on certain types of lymphocytes and which are also involved in many types of cancer;
* Treating participants with Pembrolizumab, which is approved by the FDA for the treatment of Metastatic Melanoma, a Cancer of the skin;
* Collecting blood and tissue samples and other related medical information to learn more about the development of cancer and predictors of response;
* And hoping to learn how the combination of study drugs work in the treatment of cancer to help develop new treatments.
The FDA (the U.S. Food and Drug Administration) has not approved B-701 as a treatment for any disease.
The FDA has not approved Pembrolizumab for Bladder Cancer but it has been approved for other uses.
This is the first time that B-701 in combination with Pembrolizumab will be given to humans.
In this research study, Investigators are...
* Testing the effectiveness and safety of the combination of two experimental drugs (B-701 and Pembrolizumab);
* Learning about the good and/or bad effects the drugs have on participants and their cancer;
* Administering B-701 and Pembrolizumab, which are antibodies (proteins that bind to other molecules), because...
* B-701 binds to a protein receptor called FGFR3 (fibroblast growth factor receptor 3). FGFR3 has been found to be present (expressed) or changed (mutated) on the surface of in many types of cancer cells. Targeting FGFR3 may inhibit cancer growth.
* Pembrolizumab binds to a protein cell surface receptor called PD-1, which is found on certain types of lymphocytes and which are also involved in many types of cancer;
* Treating participants with Pembrolizumab, which is approved by the FDA for the treatment of Metastatic Melanoma, a Cancer of the skin;
* Collecting blood and tissue samples and other related medical information to learn more about the development of cancer and predictors of response;
* And hoping to learn how the combination of study drugs work in the treatment of cancer to help develop new treatments.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: