Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma

Inclusion Criteria:

• Be willing and able to provide written informed consent for the trial and adhere totrial procedures.
• Have histologically confirmed relapsed (disease progression after most recent therapy)or refractory (failure to achieve complete response [CR] or partial response [PR] tomost recent therapy) classical Hodgkin Lymphoma).
• Must have received at least standard first line chemotherapy for classical HodgkinLymphoma, containing an anthracycline.
• Must have failed or declined autologous stem cell transplantation (ASCT), or not be acandidate for ASCT.
• May have received prior therapy with pembrolizumab (or an equivalent checkpointinhibitor or anti-PD-L1 antibody), but not in combination with bendamustine.
• May have received a prior autologous stem cell transplant but must be at least ≥100days post-auto-transplant, and all transplant- related adverse events must haveresolved to a grade 1 or less, and patients are not on immunosuppression, and meet allother eligibility criteria.
• Must have measurable or evaluable disease.
• Must have Eastern Cooperative Group (ECOG) performance status 0-1.
• Must have an estimated life expectancy of greater than 90 days.
• Demonstrate adequate organ and bone marrow function.
• If female of child-bearing potential, must have a negative pregnancy test within 72hours prior to the first dose of study treatment.
• All participants must be willing to use adequate contraception for the duration oftreatment with study drugs and continue for 120 days after the last dose of studydrug.
• Must be available for treatment, assessment and follow-up.

Exclusion Criteria:

• There is known severe (≥ Grade 3) hypersensitivity to pembrolizumab or bendamustine.
• Patient receiving any other investigational agents, or has participated in a study ofan investigational agent and has received study therapy or used an investigationaldevice within 4 weeks of the first dose of treatment.
• Patient is receiving any other, non-investigational, chemotherapy, radiotherapy, smallmolecule, or biologic agent within 4 weeks of the first dose of treatment, or who hasnot recovered from adverse events due to a previously administered agent.
• Patient has had a prior monoclonal antibody within 4 weeks prior to first dose oftherapy in the study, or who has not recovered from adverse events due to agentsadministered more than 4 weeks earlier.
• Patient has received pembrolizumab, or another anti-PD1, or anti-PD-L1, anti-PD-L2,anti-CD137, anti-CTLA-4, or anti-OX-40 antibody, or any other antibody or drugspecifically targeting T-cell co-stimulation or checkpoint pathways, with diseaseprogression whilst on therapy, or within 3 months of completion of this line oftherapy, without intervening systemic therapy (including chemotherapy, antibody drugconjugates or other targeted agents).
• Patient has received prior treatment with bendamustine, either as monotherapy or aspart of a combination regimen.
• Patient has undergone prior allogeneic hematopoietic stem cell transplant.
• Patient has another concurrent active malignancy (excluding non-melanoma skin canceror carcinoma in situ of the cervix that has undergone potentially curative therapy),and must be disease-free and off treatment for > 3 years.
• Patient has known active central nervous system or meningeal disease.
• Patients with active or past documented autoimmune disease that has required treatmentin the past 2 years.
• Patient is receiving systemic steroid therapy at a dose of > 10 mg/day of prednisone (or equivalent) for 7 days prior to day 1 of study treatment.
• Has an uncontrolled co-existing illness, including but not limited to: ongoing oractive infection requiring systemic therapy; systemic congestive heart failure ClassIII or IV by NYHA criteria; unstable angina pectoris or cardiac arrhythmia; inpatients status post allogeneic transplantation uncontrolled GVHD.
• Patient has a history of (non-infectious) pneumonitis that has required steroidtreatment, or concurrent active pneumonitis.
• Patient is pregnant, or nursing, or expecting to conceive or father children withinthe projected duration of the trial, starting with the screening visit through 120days after the last dose of pembrolizumab and/or bendamustine.
• Has a known history of Human Immunodeficiency Virus (HIV), active tuberculosis (TB,Mycobacterium tuberculosis), or active hepatitis B or hepatitis C.
• Patient has received a live vaccine within 30 days prior to first dose of study drugs.
• Patient is eligible for autologous or allogeneic stem cell transplant, unless patienthas declined this, therefore rendering themselves ineligible for stem celltransplantation.