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Urinary System TumorPhase 2NCT06427057

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

A Phase 2 study testing Cadonilimab plus chemotherapy and Cadonilimab plus TKI in people with Urinary System Tumor, run by Tongji Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary System Tumor
What is being tested?
Cadonilimab plus chemotherapy and Cadonilimab plus TKI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) .
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Liu Huang, Clinical Professor contact

63639656

huangliu@tjh.tjmu.edu.cn

About this study

Official title: A Prospective, Open Label, Dual Cohort Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors

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.

Read the 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.

Being tested
Cadonilimab plus chemotherapy, Cadonilimab plus TKI
Keywords
UC，RCC，immunotherapy, neoadjuvant
Medical subject headings
Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cadonilimab plus chemotherapyDrug

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

  • Cadonilimab plus TKIDrug

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

Study groups in NCT06427057
Study groupRoleWhat they receive
UCExperimentalPatients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （gemcitabine or albumin paclitaxel) neoadjuvant treatment with no more than 6 cycles.
Receives: Drug: Cadonilimab plus chemotherapy
RCCExperimentalPatients will receive AK104 (10mg/kg ,Q3W，intravenously) plus standard regimen （TKI，e.g. sunitinib, pezopanib) neoadjuvant treatment with no more than 6 cycles.
Receives: Drug: Cadonilimab plus TKI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bladder/Kidney Preservation rate

    Evaluating the impact of neoadjuvant therapy on organ preservation function

    Measured: Up to approximately 18 Weeks (Time of surgery)

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    percentage of participants with a complete response (CR) or partial response (PR)

    Measured: Up to approximately 18 Weeks

  2. Rate of Pathologic Response

    No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen.

    Measured: Up to approximately 18 Weeks (Time of surgery) ]

  3. Overall Survival (OS)

    Overall survival is defined as the time from enrollment to death due to any cause.

    Measured: Up to approximately 36 Months

  4. Assess Adverse Events

    Assess adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427057
Sponsor's protocol ID
TJ-IRB20240519
Status last verified
May 2024
First submitted
19 May 2024
Last updated
23 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab plus chemotherapy and Cadonilimab plus TKI in people with Urinary System Tumor, run by Tongji Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu Huang, Clinical Professor (63639656, huangliu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bladder/Kidney Preservation rate (time frame: Up to approximately 18 Weeks (Time of surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06427057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.

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