Window-of-opportunity trial of nivolumab with or without the IDO inhibitor BMS-986205 in patients with resectable squamous cell carcinoma of the head and neck (SCCHN).
Bibliographic record
Abstract
TPS6595 Background: Indoleamine 2,3-dioxygenase (IDO1) catabolizes tryptophan to kynurenine and is highly expressed in multiple malignancies including SCCHN. Elevated IDO1 activity may contribute to an immunosuppressive tumor microenvironment and compromise therapeutic responses to immune checkpoint therapy. We designed a window-of-opportunity trial to test whether the IDO inhibitor BMS-986305 improves treatment responses and T cell function in SCCHN patients treated with nivolumab. Methods: Patients with previously untreated, resectable, pathologically confirmed SCCHN are eligible. Primaries of the oral cavity, oropharynx, larynx, hypopharynx, or nasal cavity/paranasal sinuses must be AJCC 8th edition stage II or higher (M0). Stage I oropharyngeal cancers with lymphadenopathy are also eligible. Patients are randomized 3:1 to receive either A) nivolumab 480 mg IV x 1 plus BMS-986205 100 mg PO daily starting a week prior to nivolumab and continuing for 4 more weeks (total of 5 weeks) or B) nivolumab 480 mg IV alone for 4 weeks. At the 5th week of treatment patients are assessed for response with physical exam and repeat CT scans for tumor volumes: if there is greater than 10% reduction in volume of either primary tumor or lymph node metastases, patients will be considered responders and receive another cycle of their originally assigned treatment, i.e. nivolumab 480 mg IV for a second dose +/- BMS-986205 100 mg PO daily for an additional 4 weeks followed by surgery in week 9. If tumor volume is stable or progression is noted in either the primary site or lymph nodes, patients are considered non-responders followed by definitive surgery in week 5 (i.e. after only one cycle of treatment). The primary endpoint of this study is the response rate after cycle 1 (using the criteria defined above). The projected sample size is 48 patients (36 in arm A and 12 in arm B). Secondary endpoints include safety, pathologic treatment effect and metabolic and molecular correlates of treatment in the tumor microenvironment. Clinical trial information: NCT03854032 .
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".