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Phase 2 N=24 Treatment

Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome

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

Enrolled (actual)
24
Serious AEs
45.8%
Results posted
Feb 2019
Primary outcome: Primary: 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 — 2; 7; 9; 6 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Pembrolizumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
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
2; 7; 9; 6
SECONDARY
Duration of Response
1.0; 0.8571
SECONDARY
Progression Free Survival (PFS)
0.7380; 0.6457
SECONDARY
Overall Survival (OS)
0.95; 0.7917; 0.5429
SECONDARY
Time to Onset of First Drug-related Toxicity
64.5
SECONDARY
Incidence of Adverse Events Graded Using the Common Terminology Criteria for Adverse Events Version 5.0
2; 7; 9; 6

Summary

This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IVB mycosis fungoides or Sezary syndrome that has returned after a period of improvement or has not responded to at least one type of treatment. Monoclonal antibodies, such as pembrolizumab, may block cancer growth in different ways by targeting certain cells.

Eligibility Criteria

Inclusion Criteria

  • This trial will include subjects with stage IB-IVB MF/SS (maximal stage since diagnosis will determine eligibility), and who have relapsed, are refractory, or progressed after at least one standard systemic therapy; current disease stage at time of entry will also be documented but will not be used for eligibility
  • Subjects must have the following minimum wash-out and adverse event (AE) recovery period from previous treatments without treatment between documentation of relapse/progression and enrollment of specifically:
  • >= 2 weeks for local radiation therapy
  • >= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 8 weeks
  • >= 15 weeks for anti-cluster of differentiation (CD)137 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • >= 2 weeks from resolution (i.e., = = 2 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox, and therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteroids are allowed, topical corticosteroids are allowed)
  • >= 2 weeks for phototherapy
  • >= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Life expectancy of at least 6 months
  • Performed within 10 days of treatment initiation: Leukocytes >= 2,000/mcL
  • Performed within 10 days of treatment initiation: Absolute neutrophil count >= 1,500/mcL
  • Performed within 10 days of treatment initiation: Platelets >= 100,000/mcL
  • Performed within 10 days of treatment initiation: Hemoglobin >= 9 g/dL OR >= 5.6 mmol/L
  • Performed within 10 days of treatment initiation: Serum total bilirubin = 1.5 ULN
  • Performed within 10 days of treatment initiation: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = = 60 mL/min for subject with creatinine clearance (CrCl) levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl)
  • Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) = 1 year
  • Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MK-3475 administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients who have had chemotherapy or targeted small molecule therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Note: patients with = = 45 years of age and has not had menses for greater than 1 year will be considered postmenopausal), or 3) not heterosexually active for the duration of the study; the two birth control methods can be barrier method or a barrier method plus a hormonal method to prevent pregnancy; patients should start using birth control from the time of the pre-study visit, through the course of the study and for 120 days after the last dose of study medication; the following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), copper intrauterine device, sponge, or spermicide; appropriate hormonal contraceptives will include any registered and marketed contr
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02243579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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