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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Haematological Malignancy
• Intervention / Treatment: Drug: Nivolumab Injection

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: David Ritchie, FRACP, PhD, Melbourne Health

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: RMH 2016.281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared by researchers outside of this clinical trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes