Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)
Conditions
Interventions
Product Name: Pembrolizumab
Product Code: MK-3475
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
CAS Number: 1374853-91-4
Current Sponsor code: MK-3475
Other descriptive
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 28 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety, tolerability and Overall Response Rate (ORR) of pembrolizumab in each of the three cohorts listed below. Cohort 1: Subjects with relapsed/refractory classical Hodgkin Lymphoma that have failed to achieve a response, or progressed after auto stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin. Cohort 2: Subjects with relapsed/refractory classical Hodgkin Lymphoma that are ineligible for an auto-SCT (unable to achieve a complete or partial response to salvage therapy) and have relapsed after treatment with or failed to respond to brentuximab vedotin. Cohort 3: Subjects with relapsed/refractory classical Hodgkin Lymphoma that have failed to achieve a response, progressed after stem cell transplant and have not received treatment with brentuximab vedotin. These subjects could have received brentuximab vedotin as part of primary treatment or salvage therapy.;Secondary Objective: (1)Objective: To evaluate ORR of pembrolizumab by investigator assessment according to the IWG response criteria (Cheson, 2007) in subjects with relapsed/refractory classical Hodgkin lymphoma and additionally by independent central review using the 5-point scale according to the Lugano Classification. (2)Objective: To evaluate Complete Remission Rate (CRR) of pembrolizumab in subjects with relapsed/refractory classical Hodgkin lymphoma. (3)Objective: To evaluate Progression Free Survival (PFS) and Duration of Response (DOR) in subjects with relapsed/refractory classical Hodgkin lymphoma. (4)Objective: To evaluate the Overall Survival (OS) in subjects with relapsed/refractory classical Hodgkin lymphoma. ;Primary end point(s): Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received MK-3475, including serious adverse events (SAEs) and events of clinical interest (ECIs). The primary efficacy endpoint is the Overall Response Rate (ORR), defi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoints are duration of response, progression-free survival and overall survival.;Timepoint(s) of evaluation of this end point: At each cycle and as clinically deemed | — |
Countries
Australia, Austria, Brazil, Canada, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Russian Federation, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck
Outcome results
None listed