pembrolizumab plus axitinib trial

JRCT ID: jRCT1061200062

Registered date:16/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: renal cell carcinoma
• Date of first enrollment: 04/08/2021
• Target sample size: 7
• Study type: Interventional

Intervention(s)

Pembrolizumab(200mg/body) every 3weeks, and oral axitinib (5mg/day) givien on every day for a year.
The dose of axitinib may be adjusted according to the patient's condition. The dose can be increased up to 10 mg twice daily.

Outcome(s)

• Primary Outcome: Overall response rate (RECIST ver1.1 PR or CR)

Secondary Outcome

1) Cancer specific survival, Progression free survival, Response duration, Over all survival.
2) Safety, Immune-related Adverse Events
3) Response duration by post-treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients of unresectable or metastatic non-clear cell renal carcinoma without history of drug treatment.

Exclude criteria

Karnofsky performance-status<70
Patients with autoimmune disease.
Patients with ischemic heart disease or New York Heart Association class 3 or 4 heart failure within the past year.
Patients receiving dialysis treatment.
Patients with a history of hypersensitivity for pembrolizumab or axitinib.
Pregnant patients.
Patients with liver dysfunction for Child- Pugh score B or C.

Related Information

• Primary Sponsor: Takehiro Iawata