Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation (NIVALLO)
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ClinicalTrials.gov Identifier: NCT03146468 |
Recruitment Status :
Active, not recruiting
First Posted : May 10, 2017
Last Update Posted : September 23, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Haematological Malignancy | Drug: Nivolumab Injection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 14 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation |
Actual Study Start Date : | May 8, 2017 |
Estimated Primary Completion Date : | March 1, 2022 |
Estimated Study Completion Date : | March 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Nivolumab treatment arm
Nivolumab injection 3mg/kg intravenously every 2 weeks
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Drug: Nivolumab Injection
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
Other Name: Opdivo |
- Graft versus host disease [ Time Frame: 8 weeks ]Cumulative incidence of graft versus host disease
- Graft versus host disease [ Time Frame: 24 weeks ]Cumulative incidence of graft versus host disease
- Graft versus host disease [ Time Frame: 48 weeks ]Cumulative incidence of graft versus host disease
- Overall response rate [ Time Frame: 8 weeks ]Complete remission and partial remission
- Overall response rate [ Time Frame: 16 weeks ]Complete remission and partial remission
- Overall response rate [ Time Frame: 24 weeks ]Complete remission and partial remission
- Overall response rate [ Time Frame: 48 weeks ]Complete remission and partial remission

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146468
Australia, Victoria | |
Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 |
Principal Investigator: | David Ritchie, FRACP, PhD | Melbourne Health |
Responsible Party: | Melbourne Health |
ClinicalTrials.gov Identifier: | NCT03146468 |
Other Study ID Numbers: |
RMH 2016.281 |
First Posted: | May 10, 2017 Key Record Dates |
Last Update Posted: | September 23, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | IPD will not be shared by researchers outside of this clinical trial |
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 |
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Nivolumab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |