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

Study Overview
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Brief Summary
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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.

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

Conditions
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Haematological Malignancy

Intervention / Treatment
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* Drug: Nivolumab Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab treatment arm<br>Nivolumab injection 3mg/kg intravenously every 2 weeks | Drug: Nivolumab Injection<br>* Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft versus host disease | Cumulative incidence of graft versus host disease | 8 weeks | 
| Graft versus host disease | Cumulative incidence of graft versus host disease | 24 weeks | 
| Graft versus host disease | Cumulative incidence of graft versus host disease | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | Complete remission and partial remission | 8 weeks | 
| Overall response rate | Complete remission and partial remission | 16 weeks | 
| Overall response rate | Complete remission and partial remission | 24 weeks | 
| Overall response rate | Complete remission and partial remission | 48 weeks |