An open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD).
Bibliographic record
Abstract
TPS3126 Background: Although multiple new agents have been approved for mCRPC over the last decade, median survival remains unsatisfactory at ~12-35 months. Immunotherapy targeted solely at programmed death-1 (PD-1)/PD-1 ligand-1 (PD-L1) interactions has shown limited evidence of antitumor activity in patients (pts) with prostate cancer, likely due to the immunologically “cold” nature of the tumor and low PD-L1 expression on tumor cells. However, if existing prostate cancer treatments can trigger an adaptive immune response, attracting infiltrating immune cells and increasing tumor PD-L1 expression, there is a rationale for combination with anti-PD-1/PD-L1 inhibitors to improve outcomes. The current phase 2 study will evaluate combinations of the PD-1 inhibitor nivolumab with either rucaparib (PARP inhibitor), docetaxel, or enzalutamide (androgen receptor inhibitor) in men aged ≥18 years with mCRPC (NCT03338790). Methods: Key inclusion criteria: Histologic confirmation of adenocarcinoma of the prostate, evidence of metastatic disease, ongoing androgen deprivation therapy, and evaluable tumor biopsy. Key exclusion criteria: Active brain metastases, active malignancy in prior 3 years (except apparently cured locally-curable cancers), and major surgery ≤14 days before treatment assignment. Pts will be assigned to nivolumab + rucaparib, nivolumab + docetaxel, or nivolumab + enzalutamide based on prior systemic treatment history and the presence/absence of measurable disease and homologous recombination deficiency (HRD). Nivolumab, rucaparib, and enzalutamide treatment will continue until disease progression/unacceptable toxicity (nivolumab treatment ≤2 years); docetaxel will be given for ≤10 cycles. Co-primary endpoints: Objective response per Prostate Cancer Clinical Trials Working Group 3 criteria and prostate-specific antigen response in HRD+ pts and all treated pts; secondary endpoints: Overall survival, progression-free survival, and response kinetics in HRD+ pts and all treated pts, and safety/tolerability in all treated pts. Enrollment began December 2017 with a target of ~300 pts. Clinical trial information: NCT03338790.
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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 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.002 |
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".