Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, and Other gastrointestinal cancer
Conditions
Interventions
Monotherapy with Nivolumab 360 mg, every 3 weeks intravenous administration
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.>=20 years old 2. Histologically confirmed solid tumors with unresectable advanced or recurrent lesion. 3. One of the following types of solid cancers. I. Colorectal cancer II. Stomach cancer III. Esophagus cancer IV. Biliary tract cancer V. Pancreatic cancer VI. Child-Pugh A hepatocellular carcinomar VII. Small intestine cancer VIII. Appendiceal cancer IX. Anal canal cancer X.Gastroenteropancreatic neuroendocrine. tumor XI. GIST XII. Other solid cancer 4. Refractory or intolerant to the following treatments. I. Colorectal cancer: Fluoropyrimidine, oxaliplatin, irinotecan (In case of RAS wild type, refractory or intolerant to cetuximab or panitumumab) II. Gastric cancer: No previous treatment or refractory or intorelant to standard first line treatment. Patients who are refractory to second-line treatment are not eligible. III. Esophageal cancer, Biliary tract cancer, Pancreatic cancer, Other gastrointestinal cancers: standard first line treatment 5. TMB-H identified by analysis of blood sample using Guardant360. bTMB cohort: TMB score is evalutated 14 mutations/Mb or over by FoundationOne Liquid CDx 6. Tumor tissue can be provided for PD-L1 expression analysis 7. At least one measurable lesion as defined by RECIST ver. 1.1 8. ECOG Performance Status is 0 or 1 9. Laboratory test values at baseline satisfy 10. Woman of child-bearing-potential show negative result of pregnancy test. 11. Patients agree on appropriate contraception during and after final administration. 12. Expected to survive more than 12 weeks. 13. Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) determined by RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Progression-free survival (PFS) determined by RECIST v1.1 2)Duration of response (DoR) determined by RECIST v1.1 3)Disease control rate (DCR) determined by RECIST v1.1 4)Overall survival (OS) 5)Incidences of adverse events | — |
Countries
Japan
Contacts
Public ContactYoshiaki Nakamura
National Cancer Center Hospital East Department of Gastrointestinal Oncology
Outcome results
None listed