NivoCUP-2

JRCT ID: jRCT2051200146

Registered date:04/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cancer of unknown primary
• Date of first enrollment: 27/05/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

administration of nivolumab as an intravenous infusion over 30 mintes, 240mg every two week or 480 mg
every four week, until disease progression or unacceptable toxicity

Outcome(s)

• Primary Outcome: Safety and feasibility of nivolumab for cancer of unknown primary
• Secondary Outcome: Overall response rate, disease control rate, overall survival, progression free survival, duration of response, time to response, best response, and change of tumor burden, evaluation the association between efficacy of nivolumab and PD-L1 expression (cut off; 1%, 10%, 50%)

Key inclusion & exclusion criteria

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

Include criteria

1.Subjects with histologically confirmed cancer of unknown primary site based on adequate investigation of primary sites (excludes subjects who were pathologically diagnosed with malignant melanoma, malignant lymphoma or sarcoma)
2.Treatment naive or previously treated
3. Men and women above 20-years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
5. Expected more than 90 days survival
6. Have a Evaluable disease(With or without measurable lesions in RECIST 1.1)
7. SpO2 at room air is higher than 94% by pulse oximeter within 7 days before registration
8.Patients whose latest laboratory test values performed within 7 days before enrollment meet the following criteria
9.Women of childbearing potential must agree to follow instructions for methods of contraception from the time of enrollment for the duration of treatment with nivolumab plus 5 months post-treatment completion. Women must not be breastfeeding
10.Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines

Exclude criteria

1. Indication for curative surgery or radiotherapy
2. Favorable subsets under treatable condition
3. Proven primary site before enrollment
4. Subjects with an active, chronic or recurrent autoimmune disease
5. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
6. Prior therapy with drug targeting immune-checkpoint pathways
7. History of allergy or hypersensitivity to drug components
8. Judged that the adverse events from the previous treatment influence on the study evaluation
9. Subjects with untreated symptomatic CNS metastases
10. Subjects with interstitial lung disease
11. Anti-cancer therapy within 14 days before enrollment
12. Subjects who were treated with radiotherapy within 14 days (radiotherapy for thoraciclesion within 28 days) before enrollment
13. Surgery requiring local or surface anesthesia or general anesthesia within 14 days before enrollment
14. Subjects with diverticulitis or symptomatic gastrointestinal ulcer disease
15. Subjects with uncontrollable diabetes
16. Subjects with uncontrollable pleural effusion, ascites or pericardial effusion requiring treatment
17. Subjects with stroke, cerebrovascular accident, thrombosis, or thromboembolism within 90 days before enrollment
18. Subjects with known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
19. Subjects with systemic infection requiring treatment
"20. Subjects with uncontrolled or severe cardiovascular disease, congestive heart failure,
arrhythmias, pericardial disease or cardiac amyloidosis within 90 days before enrollment"
21. Subjects with uncontrolled intercurrent illness, including mental disorder
22. Subjects with other active malignancy
23. History of organ transplantation or hematopoietic stem cell transplantation
24. Women who are pregnant or breast feeding
25. Subjects be in a state lacking consent ability
26. Subjects with unsuitable condition judged by principal investigato

Related Information

• Primary Sponsor: Nakagawa Kazuhiko