None listed
Conditions
Interventions
Drug : Phase Ib study (Dose Escalation Phase):
Increasing dose levels of paclitaxel (70 mg/m2 or 80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle) in combination with a fixed dose of nivoluma
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has provided signed written informed consent 2. Has a histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma (systemic metastasis or locally advanced unresectable gastric cancer). A subject must have previously received 1st line chemotherapy using fluoropyrimidine and platinum, and showed progression) 3. Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue (only confined to phase II study). 4. Has a life expectancy of at least 3 months 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Has measurable or evaluable disease as determined by RECIST(Response Evaluation Criteria in Solid Tumors) Version 1.1. 7. Is able to swallow and retain orally administered medication 8. Has adequate baseline organ function
Exclusion criteria
Exclusion criteria: 1. Has HER2-positive or indeterminate gastric cancer 2. Have multiple cancers 3. Have a current or past history of severe hypersensitivity to any other antibody products 4. Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 5. Have a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings 6. Have brain or meninx metastases. 7. Have pericardial fluid, pleural effusion, or ascites requiring treatment 8. Have a history of uncontrollable or significant cardiovascular disease meeting any of the following; - myocardial infarction within 180 days before study enrolment - uncontrollable angina pectoris within 180 days before study enrolment - 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 9. Have systemic infection requiring treatment 10. Are contraindicated for paclitaxel 11. Has had prior treatment with: - Require or, within 28 days before treatment, have received systemic corticosteroids (except for temporary use, e.g., for examination, prophylaxis of allergic reactions, or reduction of radiotherapy-related edema) or immunosuppressants 12. Have undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment 13. Have received radiotherapy for gastric cancer within 28 days before treatment. 14. Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody, 15. has active B-viral hepatitis or C-viral hepatitis 16. Are pregnant or breastfeeding, or possibly pregnant 17. Has any unresolved Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment. 18. Have previously received nivolumab, anti-programmed cell death-1 (PD-1) antibody, anti-PD-L1 antibody, anti-programmed cell death-ligand 2 (PD-L2) antibody, anti-CD137 antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells 19. Are incapable of providing consent for specific reasons, such as concurrent dementia 20. Are otherwise inappropriate for this study in the investigator’s or subinvestigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D);progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactSun young Rha
Yonsei University Health System, Severance Hospital
Outcome results
None listed