None listed
Conditions
Brief summary
This study aims to evaluate the safety of nivolumab for relapsed or residual haematological cancers after blood or bone marrow transplantation Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed relapse or persistent haematological malignancy post allogeneic transplant. Study details All participants in this study will be administered a drug called nivolumab every 2 weeks for up to 48 weeks. Each time you will receive the same dose (3mg/kg) intravenously (through a vein). Assessments will be carried out throughout the 48 week period to evaluate occurrence of graft versus host disease and to measure tumour response to nivolumab therapy. Study significance There is a lack of effective treatment for relapse or persistence of haematological cancer after allogeneic transplant. This study will investigate a promising new approach to treat cancer for these patients, by using the harnessing the immune system to eliminate cancer cells.
Interventions
Nivolumab C1 and C2 1.5mg/kg intravenously every 2 weeks
After cycle 2 (but pre-cycle 3), perform interim response assessment, and determine subsequent dosing as follows:
If CR or PR and less than or equal to grade 1 acute GVHD or less than or equal to mild chronic GVHD, continue 1.5mg/kg intravenously every 2 weeks for remainder of dosing for up to 48 weeks.
If SD or no response and no GVHD, increase future doses to 3mg/kg intravenously for up to 48 weeks
If SD or no response and grade 1 acute
Nivolumab C1 and C2 1.5mg/kg intravenously every 2 weeks After cycle 2 (but pre-cycle 3), perform interim response assessment, and determine subsequent dosing as follows: If CR or PR and less than or equal to grade 1 acute GVHD or less than or equal to mild chronic GVHD, continue 1.5mg/kg intravenously every 2 weeks for remainder of dosing for up to 48 weeks. If SD or no response and no GVHD, increase future doses to 3mg/kg intravenously for up to 48 weeks If SD or no response and grade 1 acute GVHD or mild chronic GVHD, continue 1.5mg/kg intravenously for up to 48 weeks If grade 2 or greater acute GVHD or moderate/severe chronic GVHD, discontinue nivolumab
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age > 18 years Prior allogeneic stem cell transplant for a haematological malignancy Confirmed relapse or persistent haematological malignancy post allogeneic transplant Immunosuppression cessation for minimum 2 weeks
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 Known autoimmune disease Positive hepatitis B virus surface antigen Positive hepatitis C virus antibody Known HIV infection
Outcome results
None listed