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

pembrolizumab plus axitinib trial (pembrolizumab plus axitinib trial)

4

Median age was 68 (26-74) years, 4 patients had PS0, 3 males and 1 female. IMDC risk classification was Intermediate 3 cases Poor 1 case. Metastatic organs were lymph nodes 2 cases peritoneal dissemination 2 cases lung 1 case bone 1 case.

The pace of enrollment was largely in line with expectations compared to the originally projected pace. However, enrollment was difficult after the phase II KEYNOTE-B61 trial in 2022, which showed the efficacy of the combination of pembrolizumab plus lenvatinib in non-papillary clear cell renal cell carcinoma.

No. of prescribed cases: 7 No. of agreed cases: 4 No. of applied cases: 4 (3 completed cases, 1 discontinued case) Three patients had chemotherapy-related TRD All of the chemotherapy-related TRD were Grade 2 or less.

In this study, the primary endpoint of efficacy was the response rate. Results showed a response rate of 75% and a good 3-year survival rate. The median progression-free survival was 13.5 months (6-44), and the median overall survival was 31.5 months (16-44).

The study of pembrolizumab plus axitinib in metastatic non-palliative clear cell renal carcinoma might be effective, but not as effective as the newly approved pembrolizumab plus lenvatinib.

July. 11, 2025

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1061200062

Takehiro Iawata

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama

takehiroiwata1221@gmail.com

Takehiro Iwata

Okayama University Hospital

2-5-1 Shikata-cho, Kita-ku, Okayama

+81-86-223-7151

takehiroiwata1221@gmail.com

Complete

Mar. 16, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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.

Both

renal cell carcinoma

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.

Overall response rate (RECIST ver1.1 PR or CR)

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

+81-86-235-7133

Jan. 26, 2021

none