Comparison · NCT04696055-15123420
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) vs Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]): Number of Participants With Safety-relevant Changes in Clinical Parameters
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. Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) vs Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]): Number of Participants With Safety-relevant Changes in Clinical Parameters. Trial comparisons, record NCT04696055-15123420. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04696055-15123420
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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 | 0 | 0.0535 | wilson | |
| Risk in group 2 | 0 | 0 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.125 | 0.0535 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab]) | Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.~Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib. | 0 | 68 | OG000 |
| Group 2 | Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment]) | Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.~Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib. | 0 | 27 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Safety-relevant Changes in Clinical Parameters
- Description
- Number of participants with clinically relevant trends observed in laboratory data, ECG data, or ECOG performance status is reported.
- Time frame
- Up to 38 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
- NCT number
- NCT04696055
- Phases
- PHASE2
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Pembrolizumab, Regorafenib (Stivarga, BAY73-4506)
- Lead sponsor
- Bayer
- Results first posted
- 2023-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04696055?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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