About this trial
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.
Eligibility criteria
Qualifiers
Age at Diagnosis: ≥18 years.
Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma.
Disease progression or intolerance during or following first-line systemic therapy.
ECOG Performance Status: 0-1.
Disqualifiers
Allergy to any component of macromolecular protein preparations; contraindications or hypersensitivity to any ingredient of Iparomlimab and Tuvonralimab Injection, Lenvatinib, or Axitinib.
Major surgery within 28 days prior to the first dose (excluding diagnostic laparoscopy; local surgery for isolated lesions is acceptable).
Positive Hepatitis B surface antigen (HBsAg) with HBV DNA >1×10³ copies/mL, or positive anti-Hepatitis C virus (HCV) antibody.
Positive anti-HIV antibody or a diagnosis of Acquired Immunodeficiency Syndrome (AIDS).
Trial design
Treatments tested in this trial
- Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib