Ph 1B B-701 in Combination With Pembrolizumab in Metastatic Transitional Cell Carcinoma of the Urothelial Tract
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|ClinicalTrials.gov Identifier: NCT02925533|
Recruitment Status : Terminated (Terminated due to safety concerns.)
First Posted : October 6, 2016
Last Update Posted : June 27, 2017
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:
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: B-701 Drug: Pembrolizumab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 14, 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: B-701 and Pembrolizumab
B-701 is a phage-derived, affinity-matured, human monoclonal antibody (mAb) specific for FGFR3. It is based on a human immunoglobulin G1 (IgG1) framework containing heavy chain VHIII and light chain VκI subgroup sequences.
Pembrolizumab is an mAb that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with programmed death-ligand 1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
Other Name: Keytruda, MK-3475
- Preliminarily Evaluate The Safety Of B-701 In Combination With Pembrolizumab For The Treatment Of TCC [ Time Frame: 2 years ]Safety will be assessed through summaries of AEs (adverse events), changes in laboratory test results, ECGs (electrocardiograms), and changes in vital signs
- To Assess The Efficacy Of B-701 In Combination With Pembrolizumab For The Treatment Of TCC [ Time Frame: 2 years ]Measured by RECIST-based assessment of response and progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925533
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Mark Pomerantz, MD||Dana-Farber Cancer Institute|