Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Inclusion Criteria31

• Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.
• Stage I-III Hodgkin lymphoma (part 3)
• Relapse or refractory disease following 1 line of multi-agent chemotherapy (not including pembro-GVD).
• Eligible for HDT/ASCT
• Achieved complete response (Deauville 3 or better) per clinical review following 2 cycles of pembro-GVD
• Be willing and able to provide written informed consent/assent for the trial.
• Be ≥ 18 years of age on day of signing informed consent.
• Have measurable disease based on Lugano 2014 criteria
• Have a performance status of 0 or 1 on the ECOG Performance Scale
• Demonstrate adequate organ function as defined in table below
• Demonstrate adequate organ function as defined in table below. Hematological\*
• Absolute neutrophil count (ANC) ≥1000 /mcL
• Platelets ≥50,000 / mcL
• Hemoglobin ≥8 g/dL Renal
• Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR
• Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Hepatic\*
• Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for subjects with liver metastases
• AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Pulmonary
• Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is \>/= 50% then there is no need to calculate adjusted) Cardiac
• Ejection fraction ≥45% Coagulation
• International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
• \*Lab values for eligibility should be based upon labs prior to Cycle 1 treatment of Pembro-GVD.
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. On the day of planned treatment, if a blood pregnancy test has not been performed within the two week window, a stat pregnancy test (urine or blood) should be performed and the results reviewed before treatment is begun.
• Female subjects of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).
• Male subjects of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).
• HIV-infected participants must have well-controlled HIV on ART, defined as:
• Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
• Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
• It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
• Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
• Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.