Comparison · NCT03257267-5d723b6f
Cemiplimab vs Investigator Choice (IC) Chemotherapy: Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Cemiplimab vs Investigator Choice (IC) Chemotherapy: Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1. Trial comparisons, record NCT03257267-5d723b6f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03257267-5d723b6f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.171 | 0.133 | 0.217 | wilson | |
| Risk in group 2 | 0.0625 | 0.0404 | 0.0955 | wilson | |
| Risk difference, group 1 minus group 2 | 0.109 | 0.0581 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.74 | 1.66 | 4.52 | log | |
| Odds ratio, group 1 over group 2 | 3.1 | 1.78 | 5.38 | log | |
| Number needed to treat, for one more participant with the outcome on Cemiplimab than on Investigator Choice (IC) Chemotherapy | 9.21 | 6.25 | 17.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cemiplimab | Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. | 52 | 304 | OG000 |
| Group 2 | Investigator Choice (IC) Chemotherapy | Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m\^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m\^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m\^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m\^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m\^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. | 19 | 304 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
- Description
ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm) (\<1 centimeter \[cm\]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- Time frame
- From date of randomization up to 40 months
- Population
- The FAS included all randomized participants.
Source ClinicalTrials.gov
Trial
- Title
- Study of Cemiplimab in Adults With Cervical Cancer
- NCT number
- NCT03257267
- Phases
- PHASE3
- Conditions
- Squamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer
- Interventions
- Cemiplimab, Investigator Choice (IC) Chemotherapy
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2022-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03257267?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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