Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma
|ClinicalTrials.gov Identifier: NCT02837042|
Recruitment Status : Terminated (Poor accrual)
First Posted : July 19, 2016
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Penile Squamous Cell Carcinoma||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||October 2019|
|Actual Study Completion Date :||October 2019|
Experimental: Pembrolizumab 200 mg
Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.
Pembrolizumab will be administered intravenously every 3 weeks.
Other Name: Keytruda
- Objective tumor response rate [ Time Frame: Baseline up to two years ]The response rate will be evaluated every 3 weeks using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in addition to immune related criteria based on patterns of response.
- Duration of response and stable disease [ Time Frame: From the first treatment up to two years ]Objective tumor response rates will be accumulated until disease progression by immune related criteria, death, or intolerable toxicities.
- Progression-free survival [ Time Frame: Baseline up to two years ]The duration of time from the start of treatment to the first documentation of tumor progression.
- Overall survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]Length of subject survival after starting study treatment
- Number of adverse events [ Time Frame: Baseline up to two years ]Adverse events reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837042
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Georgia|
|Winship Cancer Institute at Emory University|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Lisle Nabell, MD||University of Alabama at Birmingham|