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

NCT06427057 | Not Yet Recruiting Phase 2

• 1 other identifier: TJ-IRB20240519
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary System Tumor

Keywords

UC，RCC，immunotherapy, neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Bladder/Kidney Preservation rate

  Evaluating the impact of neoadjuvant therapy on organ preservation function

  Up to approximately 18 Weeks (Time of surgery)

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to approximately 18 Weeks

• Rate of Pathologic Response

  Up to approximately 18 Weeks (Time of surgery) ]

• Overall Survival (OS)

  Up to approximately 36 Months

• Assess Adverse Events

  12 months

Study Arms (2)

UC

EXPERIMENTAL

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

Drug: Cadonilimab plus chemotherapy

RCC

EXPERIMENTAL

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

Drug: Cadonilimab plus TKI

Interventions

Cadonilimab plus chemotherapy DRUG

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

UC

Cadonilimab plus TKI DRUG

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

RCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Urologic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Liu Huang, Clinical Professor

  Tongji Hospital , Wuhan, Hubei Province, China, 430030

  PRINCIPAL INVESTIGATOR

• Xiao Yu, Clinical Professor

  Tongji Hospital , Wuhan, Hubei Province, China, 430030

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Huang, Clinical Professor

CONTACT

63639656; huangliu@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-05