Combining Cadonilimab and Lenvatinib for Advanced Clear Cell Kidney Cancer
A Single Arm, Phase II Trial of Cadonilimab (AK104) Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
This study is testing whether combining two drugs, Cadonilimab and Lenvatinib, can help people with advanced clear cell kidney cancer who have already tried other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | cadonilimab, lenvatinib, immunotherapy, prednisone, cardunilimab, cartunilimab |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06035224 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the safety and efficacy of Cadonilimab (AK104) in combination with Lenvatinib for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have previously undergone immunotherapy. The study is designed as a single-arm, multicenter trial enrolling 28 patients, with treatment continuing until disease progression or unacceptable side effects occur. Patients will receive Lenvatinib orally and Cadonilimab via intravenous infusion, with tumor responses assessed every six weeks during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced metastatic clear cell renal cell carcinoma who have experienced disease progression after prior immunotherapy.
Not a fit: Patients who have not received prior immunotherapy or those with other types of renal cell carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced ccRCC who have not responded to prior immunotherapy.
How similar studies have performed: While this approach is novel in this specific combination, previous studies have shown promise in using targeted therapies and immunotherapies for renal cell carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Provide written informed consent/assent for the trial.
2. Be ≥18 and ≤ 75 years of age on day of signing informed consent. 3）Have histologically or cytologically confirmed diagnosis of RCC with advanced/metastatic disease with clear cell component.
4)Have previous immunotherapy combined treatment progression（ only second line systemic therapy for advanced RCC included) 5)Have measurable disease per RECIST 1.1 as assessed by the investigator /site radiologist.
6)Have estimated life expectancy of at least 3 months. 7)Have ECOG PS 0-1. 8)Hematology: i. absolute neutrophil count (ANC) ≥ 1.5 × 109/L ; ii. platelets ≥ 100 × 109/L ; iii. hemoglobin ≥ 90 g/L.
9)Renal: i. calculated creatinine clearance \* (CrCl) ≥ 60 mL/min; \* CrCl will be calculated using the Cockcroft-Gault formula CrCL (mL/min) = {(140-age) × body weight (kg) × F }/(SCr (mg/dL) × 72) ii. urine protein \< 2 + or 24-hour urine protein must be \< 2.0 g.
10)Hepatic: i. serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 3 × ULN, ≤ 5 × ULN with liver metastasis; iii. serum albumin (ALB) ≥ 28 g/L.
11)Coagulation function: i. international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Exclusion Criteria:
1. Has history of allergies to monoclonal antibodies, any components of cadonilimab and lenvatinib
2. Has a known additional malignancy that has progressed or has required active treatment. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded.
3. Has prior Dual immunotherapy treatment (any anti-PD-1/PD-L1 combined with anti-CLTA-4 ).
4. Has Uncontrolled clinical symptoms or diseases of the heart
5. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days （prednisone\>10 mg/day or equivalent dose)
6. Has active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Subjects with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
7. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
8. Has an active tuberculosis and syphilitic infection.
9. Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibodies).
10. Has known active Hepatitis B (e.g., Hepatitis B surface antigen \[HBsAg\] reactive and HBV-DNA\>500 IU/ml) or Hepatitis C virus (e.g., HCV RNA \[qualitative\] is detected).
11. Has never recovered from previous anti-tumor treatment toxicity
12. Has active bleeding disorder or other history of significant bleeding episodes .
13. drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
14. Is pregnant or breastfeeding, or expecting to conceive children duration of the trial.
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Where this trial is running
Shanghai, Shanghai
- Shanghai Renji Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: jiwei Huang, Dr
- Email: jiweihuang@outlook.com
- Phone: 8613651682825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.