Trial · NCT02569242
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
NCT02569242, Phase 3, Completed, Ono Pharmaceutical Co., Ltd.; results first posted 2022-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer. Trials, record NCT02569242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02569242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
- NCT number
- NCT02569242
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 419 participants, actual
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Conditions
- Esophageal Cancer
- Interventions
- Nivolumab, Docetaxel/Paclitaxel
- First posted
- 2015-10-06
- Last updated
- 2022-07-06
- Results first posted
- 2022-01-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive. | |
| Secondary | Progression-free Survival | ("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375. | Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)." |
| Secondary | Duration of Response | ("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375. | Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)." |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | (Date of death from any cause - Date of randomization + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive. | months | MEDIAN | |
| SECONDARY | Progression-free Survival | (Earlier date on which either the overall response was assessed as PD or the subject died of any cause - Date of randomization + 1) / 30.4375. | months | MEDIAN | |
| SECONDARY | Duration of Response | (Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause - Date of first assessment of confirmed CR or PR + 1) / 30.4375. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Nivolumab Arm | 10.9 | 95% Confidence Interval 9.2 to 13.3 | months | |
| Overall Survival | Active Comparator Arm （Docetaxel/Paclitaxel） | 8.4 | 95% Confidence Interval 7.2 to 9.9 | months | |
| Progression-free Survival | Nivolumab Arm | 1.7 | 95% Confidence Interval 1.5 to 2.7 | months | |
| Progression-free Survival | Active Comparator Arm （Docetaxel/Paclitaxel） | 3.4 | 95% Confidence Interval 3.0 to 4.2 | months | |
| Duration of Response | Nivolumab Arm | 6.9 | 95% Confidence Interval 5.4 to 11.1 | months | |
| Duration of Response | Active Comparator Arm （Docetaxel/Paclitaxel） | 3.9 | 95% Confidence Interval 2.8 to 4.2 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab Arm | 210 | |
| Overall Study | STARTED | Active Comparator Arm （Docetaxel/Paclitaxel） | 209 | |
| Overall Study | COMPLETED | Nivolumab Arm | 209 | |
| Overall Study | COMPLETED | Active Comparator Arm （Docetaxel/Paclitaxel） | 208 | |
| Overall Study | NOT COMPLETED | Nivolumab Arm | 1 | |
| Overall Study | NOT COMPLETED | Active Comparator Arm （Docetaxel/Paclitaxel） | 1 |
Source ClinicalTrials.gov
Adverse events260
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nivolumab Arm | 24 | 209 | |
| other | Anaemia | Blood and lymphatic system disorders | Active Comparator Arm （Docetaxel/Paclitaxel） | 61 | 208 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nivolumab Arm | 0 | 209 | |
| other | Leukopenia | Blood and lymphatic system disorders | Active Comparator Arm （Docetaxel/Paclitaxel） | 18 | 208 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivolumab Arm | 1 | 209 | |
| other | Neutropenia | Blood and lymphatic system disorders | Active Comparator Arm （Docetaxel/Paclitaxel） | 40 | 208 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab Arm | 21 | 209 | |
| other | Hypothyroidism | Endocrine disorders | Active Comparator Arm （Docetaxel/Paclitaxel） | 3 | 208 | |
| other | Abdominal pain | Gastrointestinal disorders | Nivolumab Arm | 12 | 209 | |
| other | Abdominal pain | Gastrointestinal disorders | Active Comparator Arm （Docetaxel/Paclitaxel） | 8 | 208 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab Arm | 7 | 209 |
| Total, all-cause mortality | Active Comparator Arm （Docetaxel/Paclitaxel） | 5 | 208 |
| Total, other adverse events | Nivolumab Arm | 185 | 209 |
| Total, other adverse events | Active Comparator Arm （Docetaxel/Paclitaxel） | 204 | 208 |
| Total, serious adverse events | Nivolumab Arm | 68 | 209 |
| Total, serious adverse events | Active Comparator Arm （Docetaxel/Paclitaxel） | 77 | 208 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31582355 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nivolumab Arm vs Active Comparator Arm （Docetaxel/Paclitaxel）: deaths from any cause | Trial comparisons |
| Nivolumab Arm vs Active Comparator Arm （Docetaxel/Paclitaxel）: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02569242
GET https://conductscience.org/api/trials/v1/NCT02569242/events?page=2