A multicenter phase II study of avelumab in patients with locally advanced or metastatic penile cancer (PC) who are unfit for, or have progressed on or after platinum-based chemotherapy: (ALPACA).
Bibliographic record
Abstract
TPS7 Background: Squamous cell carcinoma of the penis is a rare and highly aggressive malignancy. Combination platinum-based chemotherapy is the standard of care in the metastatic setting. However, it is poorly tolerated and outcomes are dismal, underscoring an urgent unmet need for novel strategies. Since, penile cancers are often HPV-mediated and frequently overexpress PDL1, there is strong rationale to test the PDL1 inhibitor Avelumab, which is a well-tolerated drug in the setting of metastatic PC. Methods: This is a multicenter, single arm, phase 2 study of Avelumab (10mg/kg IV every 2 weeks) in patients with locally advanced or metastatic PC unfit for or progressed on platinum-based chemotherapy. A Simon’s two-stage design will be used where 9 patients will be enrolled in stage 1. If there is at least 1 response defined by iRECIST (complete response [iCR], partial response [iPR], or stable disease [iSD]) the study will proceed to stage 2, where an additional 15 patients will be enrolled. The primary objective is to demonstrate the anti-tumor activity of avelumab by objective response rate (ORR) according to (iRECIST). Secondary endpoints include: PFS, OS in patients determined to have PD-L1 positive tumors (including infiltrating immune cells) by the GMP verified Dako PD-L1 IHC 22C3 pharmDx test with thresholds of <1%, 1-49%, and ≥ 50% to define PD-L1 positivity, and in all enrolled patients. Secondary objectives also include assessing pathologic complete response rate (pCR) for patients undergoing surgery in the treatment time course, evaluation of safety and immunogenicity profile of Avelumab. The study is now open and actively accruing with further centres opening imminently. Funding Source: Pfizer. Clinical trial information: 03391479.
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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 | 0.000 | 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".