A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors

Trial Title: A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors

NCT ID: NCT06427057

Condition: Urinary System Tumor

Conditions: Official terms:
Urologic Neoplasms

Conditions: Keywords:
UC，RCC，immunotherapy, neoadjuvant

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cadonilimab plus chemotherapy
Description: AK104 (10mg/kg ,Q3W，intravenously) plus chemotherapy（e.g. gemcitabine or albumin paclitaxel，dosage based on guidelines or instructions）
Arm group label: UC

Intervention type: Drug
Intervention name: Cadonilimab plus TKI
Description: Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus TKI（e.g. sunitinib, pezopanib，dosage based on guidelines or instructions)
Arm group label: RCC

Summary: This is an open label, dual cohort ,phase II study to explore efficacy and safety of cadonilimab(PD-1/CTLA-4 Bispecific Antibody) combined with standard regimen neoadjuvant treatment in urothelial carcinoma（UC） and renal cell carcinoma（RCC）, with evaluating successful preservation rate of bladder/kidney.

Detailed description: UC and RCC confirmed by histopathology or cytology prior have not received systematic treatment, who had indications for surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. This study enrolled 20 cases in each cohort of UC and RCC，pts received neoadjuvant treatment containing cadonilimab for no more than 6 cycles.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Voluntary agreement to provide written informed consent. - Male or female, Age ≥ 18 years. - Predicted survival ≥ 12 weeks. - Histologically confirmed diagnosis of urothelial carcinoma（UC） and renal cell carcinoma（RCC）. - Prior no antitumor systematic treatment . - Have clinically non-metastatic high risk urothelial carcinoma (cT2-T4a, N0-3, M0) . - High risk renal cell carcinoma (≥ T2Nx or TanyN+)，include subjects with only Oligotransfer. - Willing to undergo surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment. - Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. - Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. Exclusion Criteria: - Has received other antitumor therapy before planned start of trial treatment. - History of major surgery within 4 weeks of planned start of trial treatment. - Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive. - Has received a live virus vaccine within 4 weeks of planned start of trial treatment. - NYHA Class III heart failure. - Suffering from active infection requiring systemic treatment. - Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD; - Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment. - History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above. - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. - Pregnancy or lactation. - Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: July 1, 2024

Completion date: December 1, 2027

Lead sponsor:
Agency: Tongji Hospital
Agency class: Other

Source: Tongji Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06427057