Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation

Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation

This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).

Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.

Inclusion Criteria:

• Prior allogeneic stem cell transplant for a haematological malignancy
• Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
• Immunosuppression cessation for minimum of 2 weeks
• Life expectancy > 2 months
• ECOG performance status 0-2
• Greater than or equal to 30% CD3+ donor chimerism
• Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
• AST and ALT ≤ 3 times upper limit of normal
• Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
• Signed written informed consent

Exclusion Criteria:

• Current evidence of any grade of GVHD
• Prior history of grade 2 or higher acute GVHD
• Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
• Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
• Positive hepatitis B virus surface antigen
• Positive hepatitis C virus antibody
• Known human immunodeficiency virus infection