Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome
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|ClinicalTrials.gov Identifier: NCT02243579|
Recruitment Status : Completed
First Posted : September 18, 2014
Results First Posted : February 5, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Mycosis Fungoides and Sezary Syndrome Refractory Mycosis Fungoides and Sezary Syndrome Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7 Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To assess the response rate of MK-3475 (pembrolizumab) in subjects with relapsed/refractory mycosis fungoides/Sezary syndrome (MF/SS).
I. To explore the clinical activity of MK-3475 in subjects with relapsed/refractory MF and SS with respect to the following endpoints: duration of response (DOR); progression-free survival (PFS); overall survival (OS).
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving complete response [CR]) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of MK-3475 for the Treatment of Relapsed/Refractory Mycosis Fungoides/Sezary Syndrome|
|Actual Study Start Date :||October 15, 2014|
|Actual Primary Completion Date :||January 4, 2018|
|Actual Study Completion Date :||April 1, 2019|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving CR) in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome [ Time Frame: Up to 3.2 years ]A generalized linear model for the objective response rate used a binominal error distribution. The model included as covariates all available baseline predictors of the missing outcomes.
- Duration of Response [ Time Frame: The time interval between the date of first response (CR/PR) and the date of progression as assessed by standard Mycosis Fungoides and Sezary Syndrome response criteria, assessed at 26 and 52 weeks ]Was estimated using the Kaplan-Meier method (Duration of Response Probability).
- Progression Free Survival (PFS) [ Time Frame: The time from allocation to the first documented disease progression or death due to any cause, whichever occurs first, assessed at 26 and 52 weeks ]Was estimated using the Kaplan-Meier method (Progression Free Survival Probability).
- Overall Survival (OS) [ Time Frame: The time from randomization to death due to any cause, assessed at 52, 104 and 156 weeks ]Was estimated using the Kaplan-Meier method (Overall Survival Probability).
- Time to Onset of First Drug-related Toxicity [ Time Frame: Up to 4 years ]Summary statistics (mean and SD) for time to onset of first drug-related toxicity was provided.
- Incidence of Adverse Events Graded Using the Common Terminology Criteria for Adverse Events Version 5.0 [ Time Frame: Up to 4 years ]Adverse events were summarized as counts and frequencies by toxicity grade.
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): NCT02243579
|United States, California|
|Stanford Cancer Institute Palo Alto|
|Palo Alto, California, United States, 94304|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pennsylvania/Abramson Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Youn Kim||Cancer Immunotherapy Trials Network|