CheckMate 602: An open-label, randomized, phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide and dexamethasone in relapsed/refractory multiple myeloma.
Bibliographic record
Abstract
TPS8052 Background: Multiple myeloma (MM) cells may evade immune surveillance by suppressing immune responses through the PD-1 pathway, via upregulation of PD-L1.1Nivolumab (nivo), a PD-1 immune checkpoint inhibitor that blocks PD-L1 interaction and disrupts MM-mediated PD-1 signaling, demonstrated modest activity as monotherapy in patients (pts) with relapsed/refractory multiple myeloma (RRMM) in a phase 1b study.2 Pomalidomide, an immunomodulatory drug (IMiD), may sensitize MM cells to PD-1 blockade, and has shown efficacy with dexamethasone (Pd) for RRMM. Elotuzumab (elo), an anti-SLAMF7 monoclonal antibody, directly activates natural killer cells and facilitates antibody-dependent cell-mediated cytotoxicity. Preclinical work suggests PD-1 blockade may enhance elo efficacy3; thus nivo + Pd + elo may increase clinical benefit. Methods: CheckMate 602 (NCT02726581) is a phase 3, open-label, randomized study of efficacy and safety of nivo + Pd (N-Pd) vs Pd in pts with RRMM. Nivo combined with elo + Pd (NE-Pd) will be evaluated in an exploratory arm. Eligible pts must have measurable MM after ≥2 prior lines of therapy (LoTs) that included an IMiD and proteasome inhibitor, each for ≥2 consecutive cycles, alone or combined, and be refractory to their last LoT. Pts with prior elo are eligible. A planned 406 pts will be randomized 3:3:1 to N-Pd, Pd and NE-Pd, stratified by LoT (2 vs 3+) and International Staging System disease stage (I–II vs III). Pts in the Pd arm may cross over to the NE-Pd arm at disease progression. Pts are enrolled at 119 sites in 13 countries. Coprimary endpoints (N-Pd and Pd arms): objective response rate (ORR) and progression-free survival (PFS), assessed by an independent review committee. Secondary endpoints (N-Pd and Pd arms): time to response, duration of response, investigator-assessed ORR and PFS. Exploratory endpoints include ORR and PFS (NE-Pd arm), and safety/tolerability and minimal residual disease status (all arms). 1. Liu et al. Blood 2007;110:296–304 2. Lesokhin et al. JCO 2016;34:2698–704 3. Bezman et al. Haematologica 2016;101:161–2 [S450] Study support: BMS. Writing support: A Gill, Caudex, funded by BMS. Clinical trial information: NCT02726581.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".