A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)
- Conditions
- Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, and Other gastrointestinal cancer
- Registration Number
- JPRN-UMIN000033182
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 70
Not provided
1.History of highly sensitive reactions to other antibody formulations. 2.Considered that side effects from previous medication or surgery affect the safety assessment. 3.Complication or a history of chronic or recurrent autoimmune disease. 4. History of another malignancy within 3 years of baseline (BL). 5. Have central nervous system metastasis. 6. Complications or history of interstitial lung disease, pulmonary fibrosis or radiation pneumonitis. 7. Complication of Diverticulitis or symptomatic gastrointestinal ulcer disease. 8. Have pericardial effusion, pleural effusion or ascites requiring sustained treatment. 9. Uncontrolled tumor associated pain. 10. History of transient cerebral ischemic attack or cerebral vascular accident within 180 days of BL. 11. History of thrombosis or thromboembolism. 12. cardiovascular disease. 13. Uncontrollable diabetes mellitus. 14. Have systemic infection requiring treatment. 15. Requires or has a history of transplantation therapy. 16. History of severe allergy. 17. Have bowel obstruction. 18. Received following therapies within 28 days of BL - systemic adrenocortical hormone or immunosuppressant. - other unapproved drugs - adhesions such as pleura or pericardium - surgical therapy with general anesthesia - radiation therapy 19. Received following therapies within 14 days of BL - any antineoplastic agent - surgical therapy with local or surface anesthesia 20. Received radiopharmaceuticals within 56 days of BL. 21. Either HIV antibody, HBs antigen or HCV antibody test is positive. 22. Pregnant, nursing or suspected pregnancy. 23. Previous therapeutic history for anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD 137, anti-CTLA-4 antibody or other T cell regulation. 24. Patient lacking consent ability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method