Status:
RECRUITING
A Study of Cadonilimab（AK104） Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Ruijin Hospital
Shanghai Zhongshan Hospital
Conditions:
Clear Cell Renal Cell Carcinoma、Resistance to Immunotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a Phase II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with lenvatinib in previous immunotherapy treated advanced/metastatic clear cell renal cell...
Detailed Description
This trial is a single-arm, multicenter clinical study with the aim of enrolling 28 patients with unresectable advanced ccRCC. The study was divided into three research centers, namely Renji Hospital ...
Eligibility Criteria
Inclusion
- Provide written informed consent/assent for the trial.
- 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
- Has history of allergies to monoclonal antibodies, any components of cadonilimab and lenvatinib
- 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.
- Has prior Dual immunotherapy treatment (any anti-PD-1/PD-L1 combined with anti-CLTA-4 ).
- Has Uncontrolled clinical symptoms or diseases of the heart
- 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)
- 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.
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active tuberculosis and syphilitic infection.
- Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibodies).
- 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).
- Has never recovered from previous anti-tumor treatment toxicity
- Has active bleeding disorder or other history of significant bleeding episodes .
- drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
- Is pregnant or breastfeeding, or expecting to conceive children duration of the trial.
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Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06035224
Start Date
August 23 2023
End Date
October 31 2026
Last Update
December 18 2024
Active Locations (1)
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1
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China, 200123