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ACTIVE NOT RECRUITING
NCT07881900
PHASE3

Benmelstobart Plus Anlotinib Versus Sunitinib as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This study will compare benmelstobart plus anlotinib with sunitinib as the first treatment for adults with advanced non-clear cell renal cell carcinoma, a type of kidney cancer. Eligible participants have cancer that cannot be removed surgically, has returned locally, or has spread to other parts of the body. Patients with chromophobe, collecting duct, or renal medullary carcinoma are not eligible. Benmelstobart is an immunotherapy that blocks PD-L1, a protein involved in suppressing the immune response to cancer. Anlotinib and sunitinib are targeted medicines that inhibit signals involved in tumor growth and blood vessel formation. The study plans to enroll 126 participants at multiple centers. Participants will be randomly assigned in a 2:1 ratio to receive either benmelstobart plus anlotinib or sunitinib. Participants and study doctors will know which treatment is assigned. The main purpose is to compare how long participants live without their cancer getting worse. The study will also assess tumor response, overall survival, side effects, and quality of life.

Official title: A Randomized, Controlled, Prospective, Multicenter, Phase III Study of Benmelstobart Plus Anlotinib Versus Sunitinib as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-06-01

Completion Date

2029-06-30

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

Benmelstobart

1200 mg administered by intravenous infusion on day 1 of each 21-day cycle.

DRUG

Anlotinib

12 mg administered orally once daily on days 1 through 14 of each 21-day cycle, followed by 7 days without anlotinib. Dose modifications will follow the protocol.

DRUG

Sunitinib

50 mg administered orally once daily on days 1 through 28 of each 42-day cycle, followed by 14 days without sunitinib. Dose modifications will follow the protocol.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China