- Histological confirmation of classical Hodgkin's Lymphoma (cHL) with relapsed or
refractory disease who, for the lead-in phase, either have had a prior autologous or
allogeneic HSCT or are not eligible for HSCT, and , for the expansion phase, have had
a prior allogeneic HSCT. In the expansion phase there must be a documented CD3+ donor
chimerism of ≥20%.
- Patients must be off previous cHL therapy for at least 28 days prior to randomization
in the lead-in phase/first dose of study treatment in the expansion phase.
- At least 1 fluorodeoxyglucose (FDG) PET avid (Deauville 4/5) measurable lesion >1.5 cm
on PET-CT scan as defined by the Response Criteria for Malignant Lymphoma (for the
lead-in phase) and the Lugano Classification (for the expansion phase) that has not
previously been irradiated.
- Expansion phase: Required "de novo" or "archival" tumor biopsy, as well as required on
treatment biopsy
- Estern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Patients with prior allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) who
have had:
1. Lead-in phase: allo HSCT performed
phase: allo-HSCT performed ?4 months prior to the first dose of study treatment.
NOTE: Patients who have had allo-HSCT performed >4 months prior to the first dose
of study treatment must have discontinued all immunosuppressive therapy, and must
have no clinical evidence of GVHD; or
2. Immunosuppressive treatment for acute or chronic GVHD within 3 months prior to
randomization for the lead-in phase or prior to the first dose of study treatment
for the expansion phase (with the exception of those patients who required 15
mg/day oral prednisone or equivalent). Patients who required 15 mg/day oral
prednisone or equivalent must have discontinued it within 7 days prior to first
dose of study treatment; or
3. Acute Grade 3 or Grade 4 GVHD at any time in the past (as defined by the modified
Seattle Glucksberg criteria (Consensus Conference on Acute GVHD Grading
Criteria); or
4. Prior chronic GVHD (as defined by the NIH Consensus Development Project) that
persisted for >6 months and required systemic immunosuppression (with the
exception of those patients who required 15 mg/day oral prednisone or
equivalent). Patients who required 15 mg/day oral prednisone or equivalent must
have discontinued it within 7 days prior to the first dose of study treatment; or
5. A donor lymphocyte infusion (DLI) within 3 months prior to randomization for the
lead-in phase or first dose of study treatment for the expansion phase.
- Prior therapy with an anti PD 1 or anti PD L1 mAb.
1. Lead-in Phase: May be enrolled if patient stopped prior anti PD1 or anti-PD-L1
therapy more than one year prior to randomization and had a documented prior
response.
2. Expansion Phase: Prior therapy with an anti-PD-1 or anti-PD-L1 agent following
allo-HSCT is prohibited unless the therapy was stopped more than one year prior
to the first dose of study treatment, and the patient had a documented prior
response. NOTE: Prior therapy with an anti-PD-1 or anti-PD-L1 agent prior to
allo-HSCT is permitted with no time limits and irrespective of a documented
response.
3. Patients with a history of ?Grade 3 anti-PD-1 or anti-PD-L1-related immune
toxicity are not eligible.