Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome
|Recurrent Mycosis Fungoides and Sezary Syndrome Stage IB Mycosis Fungoides and Sezary Syndrome Stage IIA Mycosis Fungoides and Sezary Syndrome Stage IIB Mycosis Fungoides and Sezary Syndrome Stage IIIA Mycosis Fungoides and Sezary Syndrome Stage IIIB Mycosis Fungoides and Sezary Syndrome Stage IVA Mycosis Fungoides and Sezary Syndrome Stage IVB Mycosis Fungoides and Sezary Syndrome||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of MK-3475 for the Treatment of Relapsed/Refractory Mycosis Fungoides / Sezary Syndrome|
- Objective response rate (ORR), defined as a confirmed partial response (PR) or CR using global assessment standard response criteria for MF and SS [ Time Frame: Up to 5 years ]A generalized linear model for the objective response rate will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.
- DOR [ Time Frame: The time interval between the date of first response (CR/PR) and the date of progression as assessed by standard MF and SS response criteria, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
- Incidence of adverse events graded using the Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 90 days after last dose of trial treatment ]Adverse experiences will be summarized as counts and frequencies by toxicity grade. Summary statistics (median and range) for time to onset of first drug-related toxicity will be provided.
- OS [ Time Frame: The time from randomization to death due to any cause, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
- PFS [ Time Frame: The time from allocation to the first documented disease progression or death due to any cause, whichever occurs first, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
|Actual Study Start Date:||October 15, 2014|
|Estimated Primary Completion Date:||January 31, 2018 (Final data collection date for primary outcome measure)|
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
Correlative studiesBiological: Pembrolizumab
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02243579
|United States, California|
|Stanford Cancer Institute|
|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|