Esophageal Cancer MedDRA version: 20.0 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 100000004864
Conditions
Sponsors
Ono Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sex: Male or female 2. Age (at the time of informed consent): 20 years and older 3. Patients with esophageal cancer and whose major lesion in the esophagus (if already resected, the major lesion in the esophagus prior to resection) satisfies the following criteria. For patients with multiple lesions, the deepest invasion by clinical diagnosis should be considered the major lesion. Lesions other than the major lesion should be considered as secondary lesions. Esophageal cancer in this study is defined as a cancer that has primarily developed from the esophagus. • Patients with a major lesion located in the cervical esophagus or thoracic esophagus (upper, middle, or lower thoracic region; including the esophagogastric junction) • Patients whose histological type of major lesion was pathologically proven squamous cell carcinoma or adenosquamous cell carcinoma (pathological diagnosis of secondary lesions in the esophagus is not mandatory) 4. Patients who are refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs for esophageal cancer, have previously received 1 treatment regimen, and are not indicated for a radical resection. The definition of refractory should be defined as follows; and a therapy applicable to the following should be counted as 1 regimen. • Patients whose PD or recurrence was confirmed by imaging during their initial chemotherapy (including chemoradiation) or within 8 weeks after the last dose#1 of chemotherapy will be assessed as “refractory.” • Patients who underwent a radical resection (R0 resection confirmed) in conjunction with chemotherapy including neo-adjuvant/adjuvant therapy and chemoradiation (including patients who underwent chemoradiation followed by salvage surgery) whose recurrence was confirmed by imaging within 24 weeks#1 after the last dose of chemotherapy will be determined as “refractory.” • If a CR (=2 consecutive CRs confirmed by imaging after an interval of =4 weeks) was assessed as a result of the initial chemotherapy (including chemoradiation), patients whose recurrence was confirmed by imaging during the initial chemotherapy (including chemoradiation) or within 24 weeks after the last dose#1 of chemotherapy will be determined as “refractory.” #1 - [character limit-refer to explanation in protocol] 5. Patients who have at least 1 measurable or non-measurable lesion per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization. The following requirements should also be satisfied: • The primary esophageal cancer should be deemed to be non-measurable lesion. • If patients only have lesions that were previously treated with radiation, the lesion should be limited to one with confirmed aggravation by imaging after radiation. • If patients have pericardial or pleural effusion or ascites only, the lesion should be limited to one with cytologically confirmed malignancy. 6. ECOG Performance Status Score 0 or 1 7. Patients with a life expectancy of at least 3 months 8. Patients must provide tumor tissue (stored tissue or tissue from the last biopsy) for analysis of PD-L1 expression. For patients who are unable to undergo another biopsy, stored tissue can be used for analysis. Tissue specimens must contain at least 100 evaluable tumor cells and must be available before the randomization. 9. Patients whose latest laboratory data meet the below criteria within 7 days before randomization. If the date of the laboratory t
Exclusion criteria
Exclusion criteria: 1. significant malnutrition. Patients will be excluded if they are receiving intravenous hyperalimentation, or require continuous infusion therapy with hospitalization. Patients whose nutrition has been well controlled for =28 days prior to randomization may be enrolled. 2. apparent tumor invasion on organs located adjacent to the esophageal disease (e.g., the aorta or respiratory tract). Patients will be excluded if they are receiving stent therapy in esophagus or respiratory tract. 3. multiple primary cancers 4. residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or subinvestigator 5. current or past history of severe hypersensitivity to any other antibody products 6. concurrent autoimmune disease or history of chronic or recurrent autoimmune disease 7. current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence. 8. concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease 9. any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be randomized if the metastasis is asymptomatic and requires no treatment. 10. pericardial fluid, pleural effusion, or ascites requiring treatment 11. uncontrollable, tumor-related pain 12. transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before randomization 13. history of uncontrollable or significant cardiovascular disease meeting any of the following criteria: · Myocardial infarction within 180 days before randomization · Uncontrollable angina pectoris within 180 days before randomization · New York Heart Association (NYHA) Class III or IV congestive heart failure · Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure =150 mmHg or diastolic blood pressure =90 mmHg lasting 24 hours or more) · Arrhythmia requiring treatment 14. anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled. 15. uncontrollable diabetes mellitus 16. systemic infections requiring treatment 17. = Grade 2 peripheral neuropathy 18. systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before randomization 19. antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before randomization 20. surgical adhesion of the pleura or pericardium within 28 days before randomization 21. surgery under general anesthesia within 28 days before randomization 22. surgery involving local or topical anesthesia within 14 days before randomization 23. radiotherapy within 28 days before randomization, or radiotherapy to bone metastases within 14 days before randomization 24. any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before randomization 25. positive test result for any of the following: HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody 26. Patients with a negative HBs an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival (OS) between the ONO-4538 group and control group (docetaxel or paclitaxel) in patients with esophageal cancer refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.;Secondary Objective: • To compare progression-free survival (PFS) between the ONO-4538 group and control group (docetaxel or paclitaxel) in patients with esophageal cancer refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs. • To compare objective response rates between the ONO-4538 group and control group (docetaxel or paclitaxel) in patients with esophageal cancer refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs. ;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: The time from randomization until death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective response rate (ORR) 2. Disease control rate (DCR) 3. Progression free survival (PFS) 4. Duration of response 5. Time to response 6. Best overall response (BOR) 7. Maximum percent change from baseline in the sum of diameters of the target lesion ;Timepoint(s) of evaluation of this end point: These endpoints were set to assess the efficacy of ONO-4538 and docetaxel or paclitaxel from various perspectives in patients with esophageal cancer. | — |
Countries
Denmark, Germany, Italy, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed