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

NCT03146468 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: RMH 2016.281
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematological Malignancy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Overall response rate

  8 weeks

• Overall response rate

  16 weeks

• Overall response rate

  24 weeks

• Overall response rate

  48 weeks

Study Arms (1)

Nivolumab treatment arm

EXPERIMENTAL

Nivolumab injection 3mg/kg intravenously every 2 weeks

Drug: Nivolumab Injection

Interventions

Nivolumab Injection DRUG

Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor

Also known as: Opdivo

Nivolumab treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (1)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David Ritchie, FRACP, PhD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: May 8, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)