Relapsed or refractory classical Hodgkin lymphoma MedDRA version: 20.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864
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: – =18 years of age – Relapsed or refractory classical Hodgkin lymphoma – Measurable disease on spiral computed tomography (CT) or combined CT/positron emission tomography (PET) scan – Evaluable core or excisional lymph node biopsy – Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 – Adequate organ function (laboratory studies) – Negative pregnancy/lactation – Adequate contraception (males and females) Refer to the protocol for more detail on each inclusion criterion. 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 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: 1. Has severe (= Grade 3) hypersensitivity to the active substance or to any of the excipients in BV or pembrolizumab. 2. Is currently participating in or has participated in a study of an investigational agent and is currently receiving study therapy or has participated in a study of an investigational agent and has received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 3. Has a diagnosis of immunosuppression or is receiving systemic steroid therapy (exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 4. Has had a prior monoclonal antibody within 4 weeks prior to first dose of therapy in the study or who has not recovered (i.e., =Grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier. 5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy including investigational agents within 4 weeks prior to study Day 1 or who has not recovered (i.e., =Grade 1 or at baseline) from AEs due to a previously administered agent. 6. Has undergone prior allo-SCT within the last 5 years. 7. Has a known additional malignancy that is progressing or has required active treatment in the last 3 years. 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of trial treatment. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs). 10. Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial. 13. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab or 180 days after the last dose of BV. 14. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, CTLA-4 antibody (including ipilimumab), or OX-40, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 15. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. 16. Has active hepatitis B (HBV) (e.g., HBsAg reactive) or hepatitis C (HCV) (e.g., HCV RNA [qualitative] is detected). 17. Has received a live vaccine within 30 days prior to first dose. 18. Has a known history of active tuberculosis (TB; Bacillus tuberculosis). 19. Is eligible for allogeneic or autologous stem cell transplantation per investigator assessment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Progression-free Survival (PFS - secondary) 2. Objective Response Rate (ORR));Timepoint(s) of evaluation of this end point: 1. Up to approximately 40 months | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression free survival (PFS) as assessed by blinded independent central review, according to the American Society of Clinical Oncology International Working Group (IWG) response criteria [Cheson, 2007] between the treatment arms (pembrolizumab or brentuximab vedotin), including clinical and imaging data following autologous stem-cell transplantation (auto-SCT) or allogeneic stem-cell transplantation (allo-SCT). To compare overall survival (OS) between treatment arms.;Secondary Objective: To compare PFS, (PFS-secondary), as assessed by blinded Independent central review, according to the IWG response criteria [Cheson, 2007] between treatment arms., excluding clinical and imaging data following auto-SCT or allo- SCT. To compare the complete remission rate (CRR) as assessed by blinded independent central review according to the IWG response criteria [Cheson, 2007] between treatment arms. To compare the overall response rate (ORR) as assessed by blinded independent central review according to the IWG response criteria [Cheson, 2007] between treatment arms. To evaluate PFS, CRR, and ORR as assessed by the investigator according to the IWG response criteria [Cheson, 2007] by treatment arm. To evaluate the safety and tolerability of pembrolizumab.;Primary end point(s): 1. Progression-free Survival (PFS) 2. Overall Survival (OS);Timepoint(s) of evaluation of this end point: 1. Up to approximately 40 months 2. Up to approximately 40 months | — |
Countries
Australia, Brazil, Canada, Colombia, Czechia, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, New Zealand, Poland, Russian Federation, Singapore, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed