Comparison · NCT04458909-591d2560
Arm I (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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 (Nivolumab, Gemcitabine, Cisplatin / Carboplatin) vs Arm II (Gemcitabine, Cisplatin / Carboplatin): Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Trial comparisons, record NCT04458909-591d2560. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04458909-591d2560
On this page
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 | 0.364 | 0.152 | 0.646 | wilson | |
| Risk in group 2 | 0 | 0 | 0.49 | wilson | |
| Risk difference, group 1 minus group 2 | 0.364 | -0.17 | 0.646 | 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) | 2.75 | 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. | 4 | 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
- Number of Participants With Complete or Partial Response (Objective Response Rate) Through the End of Cycle 6 Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Description
CT/MRI of nasopharynx and neck or chest CT at baseline and through the end of cycle 6 are compared to determine tumor response.~Per RECIST 1.1:~* Complete response:~ * Disappearance of all lesions and pathologic lymph nodes~* Partial response:~ * 30% decrease sum of the longest diameters~ * No new lesions~ * No progression of non-target lesions
- Time frame
- Baseline through end of cycle 6 (each cycle is 21 days)
- Population
- Randomized participants with scans at baseline and end of cycle 6
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04458909-591d2560