Pembrolizumab (MK-3475) as First-line Therapy for High Risk T1 Non-Muscle-Invasive Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03504163|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Pembrolizumab (MK-3475)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase II trial of Pembrolizumab (MK-3475) as first-line therapy.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab (MK-3475) as First-Line Therapy for High Risk T1 Non-Muscle-Invasive Bladder Cancer|
|Actual Study Start Date :||June 27, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Pembrolizumab (MK-3475)
Patients will receive Pembrolizumab (MK-3475) administered after TUR as single agent initial therapy. Pembrolizumab (MK-3475) will be administered as a 200 mg IV infusion at 3-week intervals for 9 doses over a 24 week period, unless there is unacceptable toxicity or other reasons to discontinue treatment occur.
Drug: Pembrolizumab (MK-3475)
Pembrolizumab (MK-3475) will be administered as a 200 mg IV infusion at 3-week intervals for 9 doses over a 24 week period.
- The proportion of patients who are disease-free [ Time Frame: 6 months ]Response will be assessed utilizing urine cytology, cystoscopy, and TUR biopsies.
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): NCT03504163
|Contact: Dean Bajorin, MDemail@example.com|
|Contact: Guido Dalbagni, MD||646-422-4394|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Dean Bajorin, MD 646-422-4333|
|Contact: Guido Dalbagni, MD 646-422-4394|
|Principal Investigator: Dean Bajorin, MD|
|Principal Investigator:||Dean Bajorin, MD||Memorial Sloan Kettering Cancer Center|