Abstract PO-009: Phase 3 KEYNOTE-630 study of adjuvant pembrolizumab in high-risk locally advanced cutaneous squamous cell carcinoma
Bibliographic record
Abstract
Abstract Introduction: Among patients with high-risk locally advanced (LA) cutaneous squamous cell carcinoma (cSCC), approximately 20% experience local disease recurrence within 5 years after standard-of-care surgical resection and adjuvant radiotherapy. Better treatment options are needed for patients who experience recurrence after surgery. The PD-1 inhibitors pembrolizumab (pembro) and cemiplimab have shown durable antitumor activity in advanced metastatic cSCC. The randomized, double-blind, placebo-controlled, phase 3 KEYNOTE-630 (NCT03833167) trial will be conducted to evaluate adjuvant pembro in patients with resectable, high-risk, LA cSCC. Materials and Methods: Eligible patients will have histologically confirmed LA cSCC as the primary site of malignancy and have undergone complete macroscopic resection of all disease with ≥1 high-risk feature: histologically involved nodal disease with extracapsular extension, with ≥1 lymph node >2 cm in diameter or ≥2 lymph nodes involved; any gross cortical bone, skull base, and/or skull base foramen invasion; any index tumor with ≥2 of the following: tumor ≥4 cm with >6-mm depth or invasion beyond subcutaneous fat, multifocal perineural invasion for nerves <0.1 mm in diameter (≥3 foci) or any involved nerve ≥0.1 mm in diameter, poor differentiation and/or sarcomatoid and/or spindle cell histology, recurrent disease (recurrence within 3 years in the previously treated area), or satellite lesions and/or in-transit metastases, lymphatic or vascular involvement. Patients must have received adequate postoperative dose of hypofractionated or conventional radiotherapy, including a BED EQD2 >48 Gy, have ECOG PS of 0 or 1, and completed adjuvant radiotherapy ≥4 and ≤16 weeks from randomization. Patients are required to provide tumor tissue for PD-L1 testing and have an ECOG PS of 0 or 1. Approximately 570 patients will be randomly assigned 1:1 to pembro 400 mg IV every 6 weeks or placebo for approximately 1 year (≤9 cycles). Stratification factors are extracapsular extension, cortical bone invasion, and prior systemic therapy (all, yes vs no). Patients receiving placebo may be eligible to cross over to receive pembro (≤18 cycles) if first biopsy-proven recurrence occurs within 5 years. In the pembro arm, eligible patients may receive pembro retreatment for up to 18 cycles. The primary end point is recurrence-free survival per investigator assessment with biopsy confirmation and secondary end points include overall survival, health-related quality of life, and safety. Computed tomography/magnetic resonance imaging of disease-involved areas and associated lymph nodes will be performed at screening and every 12 weeks until the end of year 2, then every 6 months until the end of 5 years. Adverse events will be monitored throughout the study and for 30 days after treatment end and graded per NCI CTCAE v4.0. Results: Recruitment is underway at sites in Asia, Australia, Europe, and North and South America. Conclusions: Results of KEYNOTE-630 will elucidate the role of adjuvant pembro in patients with high-risk, LA cSCC. Citation Format: Michael Schenker, Mikhail Klochikhin, Dmitry Kirtbaya, Laurent Mortier, Martin Gschnell, Caroline Robert, Nicolas Meyer, Lukas Flatz, Stephane Dalle, Marie Beylot-Barry, Thomas Eigentler, Rachel Kloss Silverman, Burak Gumuscu, Jianda Yuan, Aase Bratland. Phase 3 KEYNOTE-630 study of adjuvant pembrolizumab in high-risk locally advanced cutaneous squamous cell carcinoma [abstract]. In: Proceedings of the AACR-AHNS Head and Neck Cancer Conference: Innovating through Basic, Clinical, and Translational Research; 2023 Jul 7-8; Montreal, QC, Canada. Philadelphia (PA): AACR; Clin Cancer Res 2023;29(18_Suppl):Abstract nr PO-009.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.003 |
| 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".