A study to evaluate the Safety and Efficacy of Nivolumab in Combination with Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D);progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method Adverse event