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 \<12 months after frontline therapy
• •* Relapse ≥12 months after frontline therapy with extra-nodal disease
• •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 - 1.
• •Adequate hematologic function defined as all of the following:
• •* Absolute neutrophil count (ANC) ≥1000/μL
• •* Hemoglobin (Hgb) ≥8 g/dL (transfusions to reach this point are not permitted)
• •* Platelets ≥50,000/μL (transfusion is not permitted)
• •Adequate liver function defined as all of the following:
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN)
• •* Total bilirubin ≤1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
• •Adequate renal function defined as serum creatinine ≤1.5 mg/dL (133 μmol/L).
• •Females of childbearing potential must have a negative serum or urine pregnancy test result within 72 hours prior to the first dose of nivolumab and must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and for 7 months following their last dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
• •Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 7 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 7 months following last dose of study drug.
• •Pregnant or lactating
• •Acute or chronic liver, renal, or pancreatic disease.
• •Any of the following cardiac diseases currently or within the last 6 months:
• •* Left Ventricular Ejection Fraction (LVEF) \<45% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO)
• •* QTc interval \>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.