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

Inclusion Criteria:

• Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapseddisease proven by biopsy at enrolling institution.

• Stage I-III Hodgkin lymphoma (part 3)

• Relapse or refractory disease following 1 line of multi-agent chemotherapy (notincluding pembro-GVD).

• Eligible for HDT/ASCT

• Achieved complete response (Deauville 3 or better) per clinical review following 2cycles 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 (GFR can also be used in place ofcreatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 Xinstitutional 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 livermetastases Pulmonary

• Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCOis >/= 50% then there is no need to calculate adjusted) Cardiac

• Ejection fraction ≥45% Coagulation

• International normalized ratio (INR) OR prothrombin time (PT), Activated partialthromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receivinganticoagulant therapy as long as PT or aPTT is within therapeutic range of intendeduse of anticoagulants

• Female subject of childbearing potential should have a negative urine or serumpregnancy within 2 weeks prior to receiving the first dose of study medication. Onthe day of planned treatment, if a blood pregnancy test has not been performedwithin the two week window, a stat pregnancy test (urine or blood) should beperformed and the results reviewed before treatment is begun.

• Female subjects of childbearing potential must be willing to use an adequate methodof contraception (see details in section 11.4.3).

• Male subjects of childbearing potential must agree to use an adequate method ofcontraception.(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 ofscreening

• Participants on ART must have achieved and maintained virologic suppressiondefined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below thelimit of detection) using the locally available assay at the time of screeningand for at least 12 weeks before screening

• It is advised that participants must not have had any AIDS-definingopportunistic infections within the past 12 months.

• Participants on ART must have been on a stable regimen, without changes indrugs or dose modification, for at least 4 weeks before study entry (Day 1) andagree to continue ART throughout the study

• Participants who have AEs due to previous anticancer therapies must have recoveredto ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequatelytreated with hormone replacement or participants who have ≤Grade 2 neuropathy areeligible.

Exclusion Criteria:

• Received more than 1 prior treatment (combined modality therapy represents 1treatment) for Hodgkin Lymphoma

• Known pregnancy or breast-feeding.

• Breast-feeding should be discontinued prior to treatment initiation.

• Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of theattending physician and/or principal investigator, makes participation in this studyinappropriate.

• Has received prior radiotherapy within 2 weeks of start of study treatment.Participants must have recovered from all radiation-related toxicities, not requirecorticosteroids, and not have had radiation pneumonitis.

• Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.

• Has active autoimmune disease that has required systemic treatment in the past 2years (i.e. with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency, etc.) is not considered a form of systemic treatment.

• Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

• Has received a live vaccine or live-attenuated vaccine within 30 days prior to thefirst dose of study drug. Administration of killed vaccines is allowed.

• Has a history of (non-infectious) pneumonitis that required steroids or has currentpneumonitis.

• Has an active infection requiring systemic therapy.

• Has not adequately recovered from major surgery or has ongoing surgicalcomplications

• Has undergone solid organ transplant at any time, or prior allogeneic hematopoieticstem cell transplantation within the last 5 years. (Subjects who have had anallogeneic hematopoietic transplant greater than 5 years ago are eligible as long asthere are no symptoms of GVHD.)

• Has a history or current evidence of any condition, therapy, or laboratoryabnormality or other circumstance that might confound the results of the study,interfere with the participant's participation for the full duration of the study,such that it is not in the best interest of the participant to participate, in theopinion of the treating investigator

• Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.