Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk

Inclusion Criteria

• Patients 18 years of age and older with Hodgkin Lymphoma who have received auto-HSCT in the previous 45-120 days.
• Complete response (CR), partial response (PR) or stable disease (SD) to salvage therapy prior to ASCT.
• High risk of residual HL post-ASCT, as determined by 1 of the following:
• Positive positron emission tomography (PET) scan defined by the Deauville scale 3-4 and within 2 months of start of high dose chemotherapy prior to ASCT
• Refractory to frontline therapy
• Relapse 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Use of a study drug ≤ 21 days or 5 half-lives (whichever is shorter) prior to the first dose of nivolumab. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of nivolumab is required.
• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
• Pregnant or lactating
• Acute or chronic liver, renal, or pancreatic disease.
• Uncontrolled diabetes mellitus. Patients with Type II diabetes are eligible if they require only oral hypoglycemic agents.
• Any of the following cardiac diseases currently or within the last 6 months:
• Left Ventricular Ejection Fraction (LVEF) 480 ms on screening electrocardiogram (ECG)
• Unstable angina pectoris
• Congestive heart failure (New York Heart Association (NYHA) ≥ Grade 2
• Acute myocardial infarction
• Conduction abnormality not controlled with pacemaker or medication
• Significant ventricular or supraventricular arrhythmias (patients with chronic rate- controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
• Valvular disease with significant compromise in cardiac function
• Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure (DBP) >100 mmHg) (patients with values above these levels must have their blood pressure (BP) controlled with medication prior to starting treatment).
• Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C. Testing at baseline is not required.
• Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.