NiVOlumab earlY induction therapy for Advanced Gastric CancER

JRCT ID: jRCTs071190025

Registered date:03/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 12/09/2019
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Nivolumab is administered within the prescribed range.

Outcome(s)

• Primary Outcome: 6 months progression free survival rate

Secondary Outcome

Safety
Response rate
Progression-free survival: PFS
Overall survival: OS
Time to treatment failure: TTF
Duration of treatment
Duration of response

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age 20 years or older when providing consent
2) Individuals who have consented in writing to receipt of the protocol treatment
3) A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment)
4) Advanced or recurrent gastric or gastroesophageal junction cancer that has been histologically identified as adenocarcinoma and that is not amenable to curative surgery
5) Patients with measurable lesions according to RECIST v1.1 (patients in whom the only evaluable lesion is the primary tumor will be excluded)
6) Patients who are refractory to *1 or unable to tolerate *2 chemotherapy with a fluoropyrimidine (FU)
*Concomitant administration of a platinum-based drug is not required
*If the cancer is HER2-positive, the patient is refractory to or unable to tolerate trastuzumab as well
7) Patients who can be administered a taxane 3 or more times as pretreatment *3 and who can receive that treatment for a period of 28 days or longer (from the date of initial administration to the date of final administration)
*Concomitant administration of ramucirumab is not required
8) Patients whose best response according to imaging assessment prior to treatment *3 would be complete/partial response(CR/PR) or stable disease (SD) according to RECIST v1.1
9) Patients who meet any of the following conditions during pretreatment *3 or within 12 weeks of the date of final administration
i) Imaging assessment reveals tumor enlargement
ii) Poorer laboratory results (e.g. tumor marker levels)
iii) Worsening clinical signs, such as worsening symptoms (as determined by the patient's primary physician)
iv) Pretreatment *3 is discontinued because the patient is unable to tolerate medication *2
*In any event, a patient who is deemed to have PD in pretreatment *3 based on imaging assessment according to RECIST v1.1 will not be enrolled
10) Within 12 weeks from the date of final administration of pretreatment *3 until the date on which consent to participate in this study is provided
11) No previous pretreatment with anti-PD-1 antibodies, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies, or some other immunotherapy
*Patients who have previously been treated with nivolumab, pembrolizumab, avelumab, or atezolizumab cannot be enrolled
12) If a patient has undergone surgery for gastric cancer (e.g. palliative surgery or surgery without resection), at least 2 weeks must have passed postoperatively and postoperative complications should have abated [staging laparoscopy (including subsequent imaging as a result) will not be considered surgery here]
13) The patient has not previously received radiation therapy for the target lesion
14) The patient is likely to survive for at least 3 months after the date of enrollment
15) The patient has a PS of 0, 1, or 2 on the ECOG Scale
16) The patient has no severe dysfunction of major organs and the patient's laboratory results from up to 14 days prior to enrollment meet the following criteria. A patient may not receive a transfusion, a hematopoietic growth factor, or a blood product up to 14 days prior to the day that laboratory results are obtained.
Neutrophil count >= 1,500/mm^3
Platelet count >= 75,000 /mm^3
Hemoglobin >= 8.0 g/dL
Total bilirubin <= 2.0 mg/dL
AST, ALT <= 100 IU/L *200 IU/L or lower when liver metastasis is noted
Serum creatinine <= 1.5 mg/dL
*1 If a patient's condition is deemed to have worsened within 12 weeks from the final date of administration of an anticancer drug or if a patient has received neoadjuvant or adjuvant chemotherapy, disease progression or recurrence will be determined during administration of an anticancer drug or within 12 weeks of the final date of administration of an anticancer drug (can be determined on the same day of the week 24 weeks later)
*2 If further administration is deemed inappropriate in terms of safety due to adverse reactions such as an allergy or neuropathy
*3 Most recent result during treatment prior to enrollment in this study

Exclude criteria

1) Patients who have received a transfusion, a blood product, or a hematopoietic growth factor (e.g. G-CSF) within 14 days prior to enrollment
2) Patients who have severe drug hypersensitivity
3) Patients with an active infection
4) Patients with poorly controlled hypertension
5) Patients with poorly controlled diabetes mellitus (patients with properly controlled diabetes who are receiving insulin therapy are acceptable)
6) If a 12-lead ECG reveals marked ECG abnormalities up to 14 days prior to enrollment or the patient has heart disease that may pose a problem
*Congestive heart failure, angina pectoris requiring medication, clear evidence of transmural myocardial infarction on an ECG, clinically evident valvular heart disease, symptomatic coronary disease, poorly controlled arrhythmia, a previous history of myocardial infarction within the last 12 months, etc.
7) Patients with interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc. according to diagnostic imaging (e.g. CT)
8) A patient with an autoimmune disorder or a history of chronic or recurrent autoimmune disease
*Patients with type I diabetes, hypothyroidism treatable through hormone replacement, or a skin disorder not requiring systemic treatment can be enrolled
9) Patients needing systemic administration of corticosteroids (not including prophylaxis or temporary administration to allow testing or prevent an allergic reaction) or immunosuppressants
10) Patients with a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction
11) Patients with active gastrointestinal tract bleeding requiring repeated transfusions
12) Patients with moderate or more severe fluid accumulation in body cavities, such as pleural effusions and ascites, that continually requires treatment such as drainage or patients who have undergone a thoracentesis within 14 days prior to enrollment in this study
13) Patients with brain or meningeal metastasis; however, patients who are asymptomatic and who do not require treatment can be enrolled
14) Patients with extensive (as determined by the patient's primary physician) bone metastasis
15) Patients with Grade 2 or more severe diarrhea according to the CTCAE or chronic watery stool
16) Patients with active multiple cancers (patients with completely resected basal cell carcinoma, Stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or with a history of some other form of cancer that has not recurred for at least 5 years can be enrolled)
17) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
18) Patients who test positive for HBsAg or antibodies to HCV
19) Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study

Related Information

• Primary Sponsor: Makiyama Akitaka
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.,Bristol-Myers Squibb Company