Comparison · NCT04458909-ca32c8a8
Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Locoregional Failure
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Locoregional Failure. Trial comparisons, record NCT04458909-ca32c8a8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04458909-ca32c8a8
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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 | 0.545 | 0.28 | 0.787 | wilson | |
| Risk in group 2 | 0 | 0 | 0.49 | wilson | |
| Risk difference, group 1 minus group 2 | 0.545 | -0.0117 | 0.787 | 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 more participant with the outcome on Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) than on Arm II (Gemcitabine, Cisplatin / Carboplatin) | 1.83 | 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 (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) | Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. | 6 | 11 | OG000 |
| Group 2 | Arm II (Gemcitabine, Cisplatin / Carboplatin) | Gemcitabine and cisplatin or carboplatin as in Arm I. | 0 | 4 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Locoregional Failure
- Description
Locoregional failure is defined as first evidence of local or regional progression, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and deaths from other causes were considered competing risks. Progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance or recurrence of any locoregional lesions is also considered progression. Failure rates were to be estimated using the cumulative incidence method and arms were to be compared using the cause-specific log-rank test. Analysis was to occur after 200 deaths. Given the small number of participants due to early study closure, only the number of patients with locoregional failure is reported.
- Time frame
- Baseline to the date of failure or last known follow-up. Maximum follow-up time was 2.3 years.
- Population
- Randomized participants
Source ClinicalTrials.gov
Trial
- Title
- Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer
- NCT number
- NCT04458909
- Phases
- PHASE3
- Conditions
Metastatic Nasopharyngeal Carcinoma, Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Metastatic Nasopharyngeal Nonkeratinizing Carcinoma, Metastatic Nasopharyngeal Undifferentiated Carcinoma, Nasopharyngeal Nonkeratinizing Carcinoma, Recurrent Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Nasopharyngeal Undifferentiated Carcinoma, Stage IV Nasopharyngeal Carcinoma AJCC v8, Stage IVA Nasopharyngeal Carcinoma AJCC v8, Stage IVB Nasopharyngeal Carcinoma AJCC v8
- Interventions
- Carboplatin, Cisplatin, Gemcitabine, Nivolumab, Questionnaire Administration
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2024-09-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04458909?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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