Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia
Bibliographic record
Abstract
ABSTRACT: We conducted a multicenter, open-label, randomized phase 2 study to assess the efficacy of nivolumab (Nivo) as maintenance therapy for patients with acute myeloid leukemia (AML) in first complete remission (CR) or CR with incomplete hematologic recovery who were not candidates for stem cell transplant. Patients were stratified and randomized to observation (Obs) or Nivo (3 mg/kg IV every 2 weeks for 46 doses). The primary end point was progression-free survival (PFS) defined as time to disease relapse or death due to any reason. Secondary end points included overall survival (OS), and evaluation of adverse events (AEs) after Nivo administration. Eighty patients were enrolled with median duration of follow-up of 24 months (33 months among survivors). PFS was 13.2 months in the Nivo arm and 10.9 months in the Obs arm. Overall PFS curves were not statistically significantly different. The median OS was 53.9 months in the Nivo arm and 30.9 months in the Obs arm. There were more AEs of any type (regardless of attribution) on the Nivo arm; 27 patients (71%) on the Nivo arm had a grade ≥3 AE compared with 5 patients (12%) on the Obs arm (P < .001). Nivo maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized phase 2 study. There were increased AEs and serious AEs (SAEs) with Nivo, but these AEs and SAEs were expected and manageable. This trial was registered at www.ClinicalTrials.gov as #NCT02275533.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".