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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03146468




Registration number
NCT03146468
Ethics application status
Date submitted
7/05/2017
Date registered
10/05/2017
Date last updated
23/09/2021

Titles & IDs
Public title
Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell 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] 0 0
RMH 2016.281
Universal Trial Number (UTN)
Trial acronym
NIVALLO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological Malignancy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab Injection

Experimental: Nivolumab treatment arm - Nivolumab injection 3mg/kg intravenously every 2 weeks


Treatment: Drugs: Nivolumab Injection
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Graft versus host disease
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Graft versus host disease
Timepoint [2] 0 0
24 weeks
Primary outcome [3] 0 0
Graft versus host disease
Timepoint [3] 0 0
48 weeks
Secondary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Overall response rate
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Overall response rate
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Overall response rate
Timepoint [4] 0 0
48 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
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

- 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

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



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03146468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Ritchie, FRACP, PhD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03146468