18 Years and up
Accepting Healthy Volunteers?
- Has relapsed (disease progression after most recent therapy) or refractory (failure to
achieve Complete Response [CR] or Partial Response [PR] to most recent therapy)
classical Hodgkin Lymphoma.
- Has responded (achieved a CR or PR) to BV or BV-containing regimens, if previously
treated with BV.
- Has measurable disease defined as ≥1 lesion that can be accurately measured in ≥2
dimensions with spiral computed tomography (CT) scan or combined CT/positron emission
tomography (PET) scan. Minimum measurement must be >15 mm in the longest diameter or
>10 mm in the short axis.
- Is able to provide an evaluable core or excisional lymph node biopsy for biomarker
analysis from an archival (>60 days) or newly obtained (within 60 days) biopsy at
Screening (Visit 1).
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
- Has adequate organ function
- Female participants of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 120 days (for participants
receiving pembrolizumab) or 180 days (for participants receiving BV) after the last
dose of study drug.
- Male participants of childbearing potential must be willing to use an adequate method
of contraception starting with the first dose of study drug through 120 days (for
participants receiving pembrolizumab) or 180 days (for participants receiving BV)
after the last dose of study drug.
- Has hypersensitivity to the active substance or to any of the excipients in BV or
- 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 study drug.
- 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 study
- Has had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose of study
drug in the study or who has not recovered (i.e., ≤ Grade 1 or at baseline) from
adverse events (AEs) due to agents administered more than 4 weeks earlier.
- 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
- Has undergone prior allogeneic hematopoietic stem cell transplantation within the last
5 years. Note: Participants who have had a transplant greater than 5 years ago are
eligible as long as there are no symptoms of graft-versus-host disease (GVHD).
- Has a known additional malignancy that is progressing or requires active treatment in
the last 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or in situ cervical cancer that has undergone potentially
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Participants with previously treated brain metastases may participate
provided they are radiologically stable (i.e., without evidence of progression by
repeat imaging), clinically stable and without requirement of steroid treatment for
≥14 days prior to the first dose of study drug.
- 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
- Has a history of (non-infectious) pneumonitis that required steroids, or current
- Has an active infection requiring intravenous systemic therapy.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- 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
(for participants receiving pembrolizumab) or 180 days (for participants receiving BV)
after the last dose of study drug.
- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1),
anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4) antibody (including ipilimumab) or OX-40
(Tumor necrosis factor receptor superfamily, member 4 [TNFRSF4]), or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Has a known history of human immunodeficiency virus (HIV)
- Has active hepatitis B (HBV) or hepatitis C (HCV).
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
- Has received a live vaccine within 30 days prior to first dose of study drug.