Comparison · NCT03929029-sae
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): 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. Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) vs Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site): serious adverse events. Trial comparisons, record NCT03929029-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03929029-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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0333 | -0.479 | 0.396 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.833 | 0.0681 | 10.2 | log | |
| Odds ratio, group 1 over group 2 | 0.8 | 0.0372 | 17.2 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) than on Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | 30 | from the risk difference interval | the interval includes no difference |
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 | Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site) | * Nivolumab will begin within 2 weeks of metastatic tissue biopsy~* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation~* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21~* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site). | 1 | 6 | EG000 |
| Group 2 | Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site) | * NIvolumab will begin within 2 weeks of metastatic tissue biopsy~* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation~* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21~* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site). | 1 | 5 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All patients who received any protocol therapy were followed for up to 2 years for adverse events.
Source ClinicalTrials.gov
Trial
- Title
- Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
- NCT number
- NCT03929029
- Phases
- PHASE1
- Conditions
- Cutaneous Melanoma
- Interventions
- Nivolumab (480 mg infusion), NeoVax plus Montanide, Ipilimumab
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2024-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03929029?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/NCT03929029-sae