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

Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03146468

Acronym

NIVALLO

Enrollment

Registered

2017-05-10

Start date

2017-05-08

Completion date

2022-03-01

Last updated

2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological Malignancy

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.

Interventions

DRUGNivolumab Injection

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Graft versus host disease	8 weeks	Cumulative incidence of graft versus host disease

Secondary

Measure	Time frame	Description
Overall response rate	8 weeks	Complete remission and partial remission

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026