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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

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

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

This trial has no locations