A randomized, phase III study of sacituzumab govitecan versus treatment of the physician’s choice in patients with endometrial cancer after platinum-based chemotherapy and immunotherapy: the ASCENT-GYN-01 study (GOG-3104/ENGOT-en26/APGOT-EN2)
Bibliographic record
Abstract
BACKGROUND: Patients with recurrent or metastatic endometrial cancer who have progressed on or after platinum-based chemotherapy and PD-(L)1 inhibitor therapy have limited treatment options and a poor prognosis. Sacituzumab govitecan is a trophoblast cell-surface antigen 2-directed antibody-drug conjugate approved for certain types of breast cancer. In the phase II TROPiCS-03 trial, sacituzumab govitecan demonstrated encouraging efficacy and manageable safety in heavily pretreated patients with advanced or metastatic endometrial cancer. PRIMARY OBJECTIVE(S): The ASCENT-GYN-01 trial aims to assess the efficacy and safety of sacituzumab govitecan versus treatment of the physician's choice in patients with endometrial cancer who have received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The primary objective is to compare the effect of sacituzumab govitecan versus treatment of the physician's choice on progression-free survival, assessed by blinded independent central review, and on overall survival. STUDY HYPOTHESIS: Patients with pretreated recurrent or persistent endometrial cancer will have improved progression-free survival and overall survival with sacituzumab govitecan compared with treatment of the physician's choice. TRIAL DESIGN: ASCENT-GYN-01 (ClinicalTrials.gov identifier NCT06486441) is a randomized, open-label, global phase III study. Patients will be randomized in a 1:1 ratio to receive sacituzumab govitecan or treatment of the physician's choice (doxorubicin or paclitaxel). MAJOR INCLUSION/EXCLUSION CRITERIA: Patients aged 18 years and older with documented evidence of recurrent or persistent endometrial cancer (endometrial carcinoma or carcinosarcoma) will be enrolled. Up to 3 prior lines of systemic therapy for endometrial cancer are allowed, including platinum-based chemotherapy and PD-(L)1 inhibitor therapy, either in combination or separately. Key exclusion criteria include uterine leiomyosarcoma or endometrial stromal sarcomas and prior treatment with a trophoblast cell-surface antigen 2-directed antibody-drug conjugate or topoisomerase I inhibitor. PRIMARY ENDPOINT(S): Dual primary endpoints are progression-free survival assessed by blinded independent central review and overall survival. SAMPLE SIZE: Approximately 640 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: June 2029. TRIAL REGISTRATION: NCT06486441; GOG-3104; ENGOT-en26; APGOT-EN2.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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 | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".