NCT07277972

Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic Therapy

An Open-Label, Single-Arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the improvement in Objective Response Rate (ORR) achieved with Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) in combination with Lenvatinib or Axitinib, in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have failed first-line systemic therapy.

Detailed description

This single-arm, multicenter clinical study aims to evaluate the improvement in Objective Response Rate (ORR) achieved with Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) in combination with Lenvatinib or Axitinib, in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have failed first-line systemic therapy.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Conditions

• RCC, Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib	Iparomlimab and Tuvonralimab Injection: 5 mg/kg, iv, q3w, for a cumulative maximum treatment duration of 2 years; Lenvatinib: Starting dose of 12 mg, po, qd, q3w; or Axitinib: 5 mg, po, bid, q3w.

Timeline

• Start date: 2026-02-15
• Primary completion: 2029-11-30
• Completion: 2031-08-31
• First posted: 2025-12-11
• Last updated: 2025-12-11