Phase 2
N=15
Nivolumab in AML in Remission at High Risk for Relapse
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome · Adult Acute Myeloid Leukemia in Remission · Blasts Under 10 Percent of Bone Marrow Nucleated Cells · Therapy-Related Myeloid Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT02532231 ↗Enrolled (actual)
15
Serious AEs
40.0%
Results posted
Oct 2024
Primary outcome: Primary: Recurrence-free Survival Rate — 8.5 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Nivolumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence-free Survival Rate |
8.5 | — |
| SECONDARY Number of Participants With Immunologic Responses to Nivolumab Among Patients With Acute Myeloid Leukemia (AML) in Complete Remission (CR) Status Post Standard Chemotherapy |
6 | — |
| SECONDARY Number of Participants Who Changed From MRD Postive to MRD Negative During Therapy With Nibolumab |
2 | — |
| SECONDARY Time to Relapse |
2 | — |
| SECONDARY Overall Survival |
NA | — |
Summary
This phase II trial studies how well nivolumab works in treating patients with acute myeloid leukemia that has decreased or disappeared but may still be in the body (remission), and is at high risk for returning (relapse). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Eligibility Criteria
Inclusion Criteria
- Patients with AML in remission (defined as CR, CR with incomplete platelet recovery -CRp-, CR with incomplete hematologic recovery -CRi-, or partial remission defined as a bone marrow with 10 mg/day or equivalent) or immune suppression medications
- Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis])
- Patients with a history of inflammatory bowel disease such as Crohn's disease and ulcerative colitis
- Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months), or with known human immunodeficiency virus (HIV) infection
- Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents
- Females who are pregnant or lactating
- Patients with history of previous immunomodulatory therapy (not including lenalidomide or thalidomide)
Data sourced from ClinicalTrials.gov (NCT02532231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.