Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma
|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: NCT02837042|
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Penile Squamous Cell Carcinoma||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 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|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
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.
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): NCT02837042
|Contact: Lisle Nabell, MDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Pam Dixon, RN, OCN, CCRP 205-975-5387 email@example.com|
|Principal Investigator: Lisle Nabell, MD|
|Sub-Investigator: Amitkumar Mehta, MD|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Arlet Minassian 323-865-0802 firstname.lastname@example.org|
|United States, Georgia|
|Winship Cancer Institute at Emory University||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Marsha Williams 404-778-4063 email@example.com|
|Principal Investigator:||Lisle Nabell, MD||University of Alabama at Birmingham|