MK-3475 (pembrolizumab) in subjects with Classical Hodgkin Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

-Be willing and able to provide written informed consent/assent for the trial. The subject
may also provide consent/assent for Future Biomedical Research. However, the subject
may participate in the main trial without participating in Future Biomedical Research.
-Be 18 years of age on day of signing informed consent.
-Must have a performance status of 0 or 1 on the ECOG Performance Scale.
-Must demonstrate adequate organ function as defined in the protocol, all screening labs
should be performed within 7 days of treatment initiation.
-Have relapsed or refractory de novo classical Hodgkin lymphoma and meet the requirements specified for one of the three cohorts in the protocol.
-Have measurable disease by CT scan, as described in the protocol.
-Be able to provide a core or excisional lymph node biopsy from an archival or newly obtained biopsy.
-Female subjects of childbearing potential must test negative for pregnancy within 72 hours of the first dose.
-Female subjects of childbearing potential and male subjects must use appropriate contraception as specified in the protocol through 120 days after the last dose of study medication.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

-Is currently participating in or has participated in a study of an investigational agent or
using an investigational device within 4 weeks of the first dose of treatment.
-Has a diagnosis of immunosuppression or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of trial
treatment.
-Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not
recovered (i.e. = Grade 1 or at baseline) from adverse events due to agents administered
more than 4 weeks earlier.
-Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)
-Additional exclusion criteria specified in the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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