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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000473369
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
31/03/2017
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial to evaluate the safety of nivolumab for relapsed or residual haematological cancers after blood or bone marrow transplantation
Scientific title
Pilot study of the tolerability of nivolumab for relapsed or residual haematological malignancies after allogeneic haematopoietic stem cell transplantation
Secondary ID [1] 291582 0
None
Universal Trial Number (UTN)
Trial acronym
NIVALLO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological malignancies 302697 0
Condition category
Condition code
Cancer 302209 302209 0 0
Hodgkin's
Cancer 302210 302210 0 0
Leukaemia - Acute leukaemia
Cancer 302211 302211 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 297649 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301623 0
The primary outcome is the safety of nivolumab post-allogeneic transplant, as measured by the cumulative incidence of acute and chronic graft versus host disease. Established criteria for acute (Glucksberg criteria) and chronic (NIH consensus criteria) will be used to assess the severity of GVHD.
Timepoint [1] 301623 0
2, 4, 8, 16, 24, 48 weeks after the first dose of nivolumab
Secondary outcome [1] 333327 0
Tumour response to nivolumab therapy using various established response criteria specific to the relevant primary haematological malignancy
Timepoint [1] 333327 0
8, 16, 24, 48 weeks after first dose of nivolumab

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
Descriptive statistics of response rate using established criteria. Survival analyses using Kaplan-Meier method. Cumulative incidence of acute and chronic GVHD calculated taking into account non-GVHD mortality as a competing risk.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296070 0
Commercial sector/Industry
Name [1] 296070 0
Bristol-Myers Squibb
Address [1] 296070 0
4 Nexus Court, Mulgrave, VIC, Australia 3170
Country [1] 296070 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Grattan Street, Parkville, VIC, Australia 3050
Country
Australia
Secondary sponsor category [1] 294963 0
None
Name [1] 294963 0
Address [1] 294963 0
Country [1] 294963 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297328 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 297328 0
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Australia
Ethics committee country [1] 297328 0
Australia
Date submitted for ethics approval [1] 297328 0
Approval date [1] 297328 0
10/11/2016
Ethics approval number [1] 297328 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73718 0
Prof David Ritchie
Address 73718 0
Royal Melbourne Hospital
300 Grattan Street, Parkville, VIC 3050
Australia
Country 73718 0
Australia
Phone 73718 0
+61 3 93422520
Fax 73718 0
Email 73718 0
david.ritchie@mh.org.au
Contact person for public queries
Name 73719 0
Prof David Ritchie
Address 73719 0
Royal Melbourne Hospital
300 Grattan Street, Parkville, VIC 3050
Australia
Country 73719 0
Australia
Phone 73719 0
+61 3 93422520
Fax 73719 0
Email 73719 0
david.ritchie@mh.org.au
Contact person for scientific queries
Name 73720 0
Prof David Ritchie
Address 73720 0
Royal Melbourne Hospital
300 Grattan Street, Parkville, VIC 3050
Australia
Country 73720 0
Australia
Phone 73720 0
+61 3 93422520
Fax 73720 0
Email 73720 0
david.ritchie@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results