pembrolizumab plus axitinib trial

The efficacy and safety of pembrolizumab plus axitinib combination thrapy for unresectable or metastatic non-clear cell renal carcinoma. - pembrolizumab plus axitinib trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1061200062

Enrollment

Registered

2021-03-16

Start date

2021-08-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of unresectable or metastatic non-clear cell renal carcinoma without history of drug treatment.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Overall response rate (RECIST ver1.1 PR or CR)	—

Secondary

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

Contacts

Public ContactIwata Takehiro

Okayama University Hospital

takehiroiwata1221@gmail.com+81-86-223-7151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026