Study of Nivolumab Combined with 177Lu-girentuximab for Kidney Cancer

Inclusion Criteria

• Have advanced kidney cancer that cannot be removed by surgery or has spread, with clear cell features or CAIX protein.
• Have at least one tumor that can be measured by specific scans.
• Have received at least one previous treatment, including a PD-1 or PD-L1 antibody.
• Be 18 years or older.
• Have a performance status score of 70 or higher, indicating the ability to care for oneself.
• Have adequate organ function, including:
  • Neutrophil count of at least 1500 cells/μL.
  • White blood cell count of at least 2500/μL.
  • Platelet count of at least 100,000/μL.
  • Hemoglobin level of at least 9.0 g/dL.
• Have liver enzymes and bilirubin levels within specified limits.
• Have normal blood clotting times unless on stable anticoagulation.
• Have a creatinine clearance of at least 40 mL/min.
• Agree to use effective contraception during and after treatment.
• Provide signed consent to participate.

Exclusion Criteria

• Have kidney cancer without clear cell features.
• Have previously received 177Lu-girentuximab.
• Have allergies to girentuximab or similar substances.
• Have received certain antibodies or radionuclides recently.
• Have untreated or symptomatic brain or spinal cord metastases.
• Have uncontrolled pain or require high-dose steroids for autoimmune conditions.
• Have stopped previous checkpoint inhibitor therapy due to side effects.
• Have received recent cancer treatment or have uncontrolled high calcium levels.
• Have had other cancers within the past three years, except for certain low-risk types.
• Have severe allergies to certain antibodies.
• Have uncontrolled HIV, hepatitis B, or hepatitis C.
• Have significant heart disease or recent stroke.
• Have serious bleeding disorders or gastrointestinal issues.
• Have recent major surgery or are pregnant or breastfeeding.
• Cannot receive nivolumab for any reason.