Last reviewed · How we verify
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
Phase 3 trial testing Nivolumab in Esophageal Cancer in 419 participants. Completed in 23 October 2020.
| Lead sponsor | Ono Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 419 |
| Start date | 14 December 2015 |
| Primary completion | 23 October 2020 |
| Estimated completion | 23 October 2020 |
| Sites | 89 locations across Denmark, Italy, Japan, Taiwan, United Kingdom, Germany, South Korea, United States |
Ono Pharmaceutical Co., Ltd.
20 and older, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab Arm | 10.9 | 9.2 – 13.3 |
| Active Comparator Arm （Docetaxel/Paclitaxel） | 8.4 | 7.2 – 9.9 |
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)."
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab Arm | 1.7 | 1.5 – 2.7 |
| Active Comparator Arm （Docetaxel/Paclitaxel） | 3.4 | 3.0 – 4.2 |
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)."
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab Arm | 6.9 | 5.4 – 11.1 |
| Active Comparator Arm （Docetaxel/Paclitaxel） | 3.9 | 2.8 – 4.2 |
Time frame: Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nivolumab Arm | Active Comparator Arm （Doc… |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Pyrexia | General disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — | — |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Bacteraemia | Infections and infestations | — | — |
| Infection | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Infectious pleural effusion | Infections and infestations | — | — |
| Reaction | System | Nivolumab Arm | Active Comparator Arm （Doc… |
|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Fatigue | General disorders | — | — |
| Malaise | General disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Pyrexia | General disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Weight decreased | Investigations | — | — |
Most-reported serious reactions: Febrile neutropenia, Pneumonia, Pyrexia, Decreased appetite, Lung infection, Hypercalcaemia, Interstitial lung disease, Neutrophil count decreased.
Data from ClinicalTrials.gov NCT02569242 adverse events section.
The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02569242.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing