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

NCT ID: NCT06427057

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-12-01

Brief 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.

Conditions

Urinary System Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UC

Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （gemcitabine or albumin paclitaxel) neoadjuvant treatment with no more than 6 cycles.

Group Type: EXPERIMENTAL

Cadonilimab plus chemotherapy

Intervention Type: DRUG

AK104 (10mg/kg ,Q3W，intravenously) plus chemotherapy（e.g. gemcitabine or albumin paclitaxel，dosage based on guidelines or instructions）

RCC

Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （TKI，e.g. sunitinib, pezopanib) neoadjuvant treatment with no more than 6 cycles.

Group Type: EXPERIMENTAL

Cadonilimab plus TKI

Intervention Type: DRUG

Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus TKI（e.g. sunitinib, pezopanib，dosage based on guidelines or instructions)

Interventions

Cadonilimab plus chemotherapy

AK104 (10mg/kg ,Q3W，intravenously) plus chemotherapy（e.g. gemcitabine or albumin paclitaxel，dosage based on guidelines or instructions）

Intervention Type: DRUG

Cadonilimab plus TKI

Patients will receive AK104 (10mg/kg ,Q3W，intravenously) plus TKI（e.g. sunitinib, pezopanib，dosage based on guidelines or instructions)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Huang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liu Huang, Clinical Professor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital , Wuhan, Hubei Province, China, 430030

Xiao Yu, Clinical Professor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital , Wuhan, Hubei Province, China, 430030

Central Contacts

Liu Huang, Clinical Professor

Role: CONTACT

huangliu@tjh.tjmu.edu.cn

63639656

Other Identifiers

TJ-IRB20240519

Identifier Type: -

Identifier Source: org_study_id