Comparison · NCT03117309-ce566058
Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC vs Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC: Number of Participants With 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. Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC vs Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC: Number of Participants With Adverse Events. Trial comparisons, record NCT03117309-ce566058. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03117309-ce566058
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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 | 1 | 0.971 | 1 | wilson | |
| Risk in group 2 | 1 | 0.901 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0291 | 0.0989 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| 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 A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC | All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B).~PART A: Nivolumab~Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment.~Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks~PART B: Nivolumab + Ipilimumab~Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4.~Nivolumab 3mg/kg: In combination with Ipilimumab~Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks | 128 | 128 | OG000 |
| Group 2 | Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC | All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B).~PART A: Nivolumab~Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment~Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks~PART B: Nivolumab + Ipilimumab~Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4~Nivolumab 3mg/kg: In combination with Ipilimumab~Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks | 35 | 35 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events
- Description
- Adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
- Time frame
- Up to 28 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
- NCT number
- NCT03117309
- Phases
- PHASE2
- Conditions
- Advanced Renal Cell Carcinoma
- Interventions
- Nivolumab 240 mg, Ipilimumab 1mg/kg, Nivolumab 3mg/kg, Nivolumab 360mg
- Lead sponsor
- Michael B. Atkins, MD
- Results first posted
- 2025-07-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03117309?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT03117309-ce566058