Comparison · NCT05665595-sae
Pembrolizumab/Vibostolimab vs Pembrolizumab: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pembrolizumab/Vibostolimab vs Pembrolizumab: serious adverse events. Trial comparisons, record NCT05665595-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05665595-sae
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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 | 0.156 | 0.131 | 0.185 | wilson | |
| Risk in group 2 | 0.0814 | 0.0634 | 0.104 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0747 | 0.041 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.92 | 1.42 | 2.6 | log | |
| Odds ratio, group 1 over group 2 | 2.09 | 1.49 | 2.93 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab/Vibostolimab than on Pembrolizumab | 13.4 | 9.2 | 24.4 | 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 | Pembrolizumab/Vibostolimab | Participants received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year). | 109 | 698 | EG000 |
| Group 2 | Pembrolizumab | Participants received 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year). | 57 | 700 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 13 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
- NCT number
- NCT05665595
- Phases
- PHASE3
- Conditions
- Melanoma
- Interventions
- Pembrolizumab/Vibostolimab, Pembrolizumab
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2025-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05665595?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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