Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial
Summary
This phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy. 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.
Timeline
- Start
- 2015-07-02
- Primary completion
- 2025-07-28
- Completion
- 2026-10-08
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm I (Nivolumab) vs Arm II (Observation); p = 0.38; Hazard Ratio (HR) 0.92 (95% CI 0.54 to 1.56); Log Rank; note: One-sided p-value NCT02275533 ↗
paper Nivo maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized phase 2 study. PMID 39928953 ↗
Publications
- Pyzer AR, Dillon LW, Sharon E, Karrison TG, Zha Y, Fulton N, Gui G, Andrew G, Streicher H, Sweet K, Yaghmour G, Liu JJ, Jonas BA, Schimmer AD, Grant S, Zeidan AM, Hildebrandt GC, Lowrey CH, Mattison RJ, Palmisiano N, Salhotra A, Tzachanis D, Baer MR, Lin TL, Patel P, Chen H, Stadler WM, Odenike O, Larson RA, Gajewski TF, Hourigan CS, Stock W, Liu H. Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia. Blood Adv. 2025 May 13;9(9):2144-2152. doi: 10.1182/bloodadvances.2024015176.
- Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |