Design and rationale of the phase II PANDORA trial: first line chemo-immunotherapy in advanced Merkel cell carcinoma
Bibliographic record
Abstract
Merkel cell carcinoma (MCC) is a rare neuroendocrine tumor of the skin with an aggressive behavior and high propensity for locoregional recurrence and metastasis. The therapeutic options in the metastatic disease are limited and are mainly based on immunotherapy or platinum-based doublets. Importantly, a significant proportion of patients experience resistance to single-agent immunotherapy highlighting the need for more active upfront combinations. The PANDORA trial [NCT 06086288] is an open label, multicenter, phase II trial evaluating the activity and safety of pembrolizumab combined with cisplatin or carboplatin and etoposide as first line treatment in patients with advanced MCC. The primary endpoint is objective response rate (ORR). Secondary objectives include overall survival (OS), progression free survival (PFS) and duration of response (DOR). Exploratory objectives include identification of immune and molecular biomarkers and assessment of Health-Related Quality of Life of pembrolizumab plus cisplatin/carboplatin and etoposide in participants with advanced/metastatic MCC. We planned to enroll 35 patients according to the study design. The combination of immune checkpoint inhibitors and chemotherapy was associated with better outcomes compared to either treatment alone in several cancer thanks to a potential synergy. Moving from a biological and clinical rationale, PANDORA may impact on the therapeutic landscape of MCC.Clinical Trial Registration: NCT06086288 (ClinicalTrials.gov).
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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 | 0.020 | 0.013 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.006 |
| Insufficient payload (model declined to judge) | 0.011 | 0.004 |
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".