Comparison · NCT02129075-sae
Arm I (CDX-301, CDX-1401, and Poly-ICLC) vs Arm II (CDX-1401 and Poly-ICLC): 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. Arm I (CDX-301, CDX-1401, and Poly-ICLC) vs Arm II (CDX-1401 and Poly-ICLC): serious adverse events. Trial comparisons, record NCT02129075-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02129075-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 | 0 | 0.114 | wilson | |
| Risk in group 2 | 0.133 | 0.0531 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | -0.133 | -0.297 | 0.00567 | 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, for one fewer participant with a serious adverse event on Arm I (CDX-301, CDX-1401, and Poly-ICLC) than on Arm II (CDX-1401 and Poly-ICLC) | 7.5 | 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 | Arm I (CDX-301, CDX-1401, and Poly-ICLC) | Patients receive recombinant Flt3 ligand (CDX-301) SC on days -7 to -1, 1-3, and 22-28 of course 1 and on days 1-3 of course 2 only; DEC-205/NY-ESO-1 fusion protein CDX-1401 SC or ID on days 1 and 2; and poly-ICLC SC on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies~Recombinant Flt3 Ligand: Given SC | 0 | 30 | EG000 |
| Group 2 | Arm II (CDX-1401 and Poly-ICLC) | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401and poly-ICLC as in Arm I. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.~DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies~Neoantigen-based Melanoma-Poly-ICLC Vaccine: Given SC~Pharmacological Study: Correlative studies | 4 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma
- NCT number
- NCT02129075
- Phases
- PHASE2
- Conditions
Cutaneous Melanoma, Melanoma, Melanoma of Unknown Primary, Mucosal Melanoma, Ocular Melanoma, Stage IIB Cutaneous Melanoma AJCC v6 and v7, Stage IIC Cutaneous Melanoma AJCC v6 and v7, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
- Interventions
- DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Recombinant Flt3 Ligand
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-11-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02129075?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.govNone 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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