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Resectable Clear Cell Carcinoma of the KidneyPhase 2NCT06574412

Cardenilimab Combined With Lenvatinib in Patients With Perioperative Resectable Clear Cell Renal Cell Carcinoma.

A Phase 2 study testing cardonilizumab combined with renvastinib in people with Resectable Clear Cell Carcinoma of the Kidney, run by The First Hospital of Jilin University.

Not yet recruiting

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

Official record
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Trial summary

This study is a single-arm, single-center, phase II clinical study. The main purpose is to evaluate the perioperative efficacy and safety of cardenilimab combined with lenvatinib in patients with resectable clear cell renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
cardonilizumab combined with renvastinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 1 Sep 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients: 18-75 years old;
  • ECOG physical condition score: 0~2 points;
  • Histologically confirmed resectable non-metastatic clear cell carcinoma of the kidney (TNM staging criteria for renal carcinoma);
  • Expected survival ≥12 weeks;
  • Have not received systemic anti-tumor therapy before;
  • Major organ function is normal, that is, relevant examination indicators within 14 days before randomization meet the following requirements: 1) Blood routine examination: a) hemoglobin ≥90 g/L (no blood transfusion within 14 days); b) Neutrophil count ≥1.5×109/L; c) Platelet count ≥100×109/L; 2) Biochemical examination: a) Total bilirubin ≤ 1.5×ULN (upper limit of normal value); b) Serum glutamic-pyruvic aminotransferase (ALT) or serum glutamic-oxalic aminotransferase (AST) ≤ 2.5×ULN; If there is liver metastasis, ALT or AST ≤ 5×ULN; c) Serum creatinine <1.5 times the upper limit of normal; Endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); 3) Routine coagulation test: a) International Standardized ratio (INR) or prothrombin time (PT) ≤1.5 X ULN. b) Activated partial thromboplastin time (APTT) ≤1.5 x ULN. 4) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
  • Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to inclusion, with a negative result, and be willing to use an appropriate method of contraception during the test period and for 8 weeks after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and within 8 weeks after the last dose of the trial drug;
  • The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.

Who cannot join

  • Other malignancies diagnosed within 5 years prior to administration, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ. If another malignant tumor or lung cancer is diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent lesions is required.
  • Currently participating in an interventional clinical study or receiving other drugs or investigational devices within 4 weeks prior to initial dosing;
  • Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137);
  • Received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose, or received major surgical treatment within 3 weeks before the first dose;
  • Have a history of bleeding, any bleeding event with a severity rating of CTCAE5.0 or higher occurring within 4 weeks prior to screening;
  • Received solid organ or blood system transplantation;
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  • Clinically uncontrolled active infections, including but not limited to acute pneumonia;
  • History of idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), and drug-related pneumonia;
  • Uncontrolled or symptomatic hypercalcemia; 10.III-IV and congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
  • Known allergic reactions to PD-1 monoclonal antibody, albumin paclitaxel, carboplatin active ingredients and/or any excipients;
  • An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic；
  • Patients requiring long-term systemic use of corticosteroids. Patients with COPD or asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local injections of corticosteroids could be enrolled；
  • Wounds that have not healed for a long time or fractures that have not healed completely;
  • Have an active infection requiring treatment or have used systemic anti-infective drugs within 1 week prior to first dosing;
  • Arterial thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), myocardial infarction, and unstable angina pectoris, occurred within 6 months before screening;
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive);
  • Untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be < 1000 copies /ml (200IU/ml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required.
  • Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection)
  • Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
  • Have received live vaccine within 30 days prior to the first dose;Note: Injectable inactivated virus vaccine against seasonal influenza is permitted; However, live attenuated influenza vaccines administered intranasally are not permitted.
  • There is a medical history, illness, treatment, or abnormal laboratory result that could interfere with the test results or prevent the subject from fully participating in the study, or the investigator believes that participation in the study is not in the subject's best interest.

About this study

Official title: The Efficacy and Safety of Cardonilizumab Combined With Lenvastinib in Perioperative Treatment of Resectable Renal Clear Cell Carcinoma-A Single-arm, Single-center, Exploratory Clinical Study

This study is a single-arm, single-center, phase II clinical study. The main purpose is to evaluate the perioperative efficacy and safety of cardenilimab combined with lenvatinib in patients with resectable clear cell renal cell carcinoma. This study included a screening period, a treatment period, and a follow-up period. After completing the examination and assessment during the screening period, qualified subjects will enter the study treatment period after signing the informed consent form. Subjects should receive induction therapy and maintenance therapy in accordance with the protocol until there is disease progression on imaging as judged by the investigator based on RECIST 1.1 standards, intolerable toxicity, or the subject voluntarily requests to terminate study treatment or withdraws information. Agree, or the researcher determines that treatment needs to be terminated. (1) Primary research endpoint: Objective response rate (ORR) of primary tumor according to RECIST 1.1 criteria (2) Secondary research endpoint: 1. According to RECIST 1.1, as assessed by the investigator: (1) Progression-free survival (Progress Free Survival, PFS); (2) Overall survival (OS); 2. Type, incidence and severity of adverse events (AE) and serious adverse events (SAE) assessed in accordance with NCI-CTCAE 5.0 . 3. Pathological response rate (MPR), R0 resection rate 4. Based on Quality of Life QoL score.

Being tested
cardonilizumab combined with renvastinib

What participants receive

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

  • cardonilizumab combined with renvastinibDrug

    Preoperative: Cardenilimab: 10 mg/kg qd intravenously, one cycle every 21 days, administered on the first day of each cycle, a total of 4 cycles. Lenvatinib: Weight \&lt;60kg, 8mg, once a day, orally, for 4 cycles Weight \&gt;60kg, 12mg, once a day, orally, for a total of 4 cycles Surgery: The patient is receiving 4 cycles of cardenilimab + Standard radical nephrectomy was performed within 30-40 days after the end of lenvatinib treatment. Postoperative: Cardenilimab: 10 mg/kg qd intravenously, 1 cycle every 21 days, administered on the 1st day of each cycle, a total of 8 cycles Lenvatinib: body weight \&lt;60 kg, 8 mg, once a day, orally , a total of 8 cycles, weight \&gt; 60kg, 12mg, once a day, orally, a total of 8 cycles.

Study groups in NCT06574412
Study groupRoleWhat they receive
Neoadjuvant -surgery-adjuvant therapy groupExperimentalPreoperative: Cardenilimab was administered at a dose of 10 mg/kg intravenously once daily, with one cycle every 21 days, for a total of 4 cycles. Lenvatinib was prescribed as follows: for patients weighing less than 60 kg, 8 mg was given orally once daily for 4 cycles; for those weighing more than 60 kg, 12 mg was administered orally once daily for a total of 4 cycles. Surgery: The patient underwent standard radical nephrectomy 30 to 40 days after completing the 4 cycles of lenvatinib treatment. Postoperative: Cardenilimab was continued at a dose of 10 mg/kg intravenously once daily, with one cycle every 21 days, for a total of 8 cycles. Lenvatinib dosing postoperatively was as follows: for patients weighing less than 60 kg, 8 mg was given orally once daily for a total of 8 cycles; for those weighing more than 60 kg, 12 mg was administered orally once daily for a total of 8 cycles.
Receives: Drug: cardonilizumab combined with renvastinib

What is being measured

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

  1. ObjectiveResponse Rate，ORR

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

    Measured: The proportion of patients whose tumor size reduction reaches predetermined limits and persists over

Secondary outcomes (7)

  1. Overall survival，OS

    OS was defined as the time from the first study treatment to the date of death from any cause

    Measured: The time from randomization to death (from any cause)

  2. Progress Free Survival，PFS

    PFS was defined as the time from randomization to tumor progression (any aspect) or death (from any cause).

    Measured: The time between the start of randomization and the progression of tumor development (in any respect

  3. Types, incidence, and severity of adverse event (AE)

    Classification per Common Terminology Criteria for Adverse Events (CTC-AE) version 5.0.

    Measured: 28 days after the last dose of study treatment

  4. Types, incidence, and severity of serious adverse event (SAE)

    Classification per Common Terminology Criteria for Adverse Events (CTC-AE) version 5.0.

    Measured: 28 days after the last dose of study treatment

  5. major pathologic response, MPR

    Measured: After neoadjuvant therapy, the percentage of surviving tumor cells in the tumor bed was less than 10

  6. After neoadjuvant therapy, the percentage of surviving tumor cells in the tumor bed was less than 10

    Measured: Standard radical nephrectomy

  7. Quality of life score

    Classified according to EORTC QLQ-C30 (V3.0 Chinese Version).

    Measured: 28 days after the last dose of study treatment

Timeline

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

  1. First posted28 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion1 Sep 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574412
Sponsor's protocol ID
2024-HS-091
Status last verified
Aug 2024
First submitted
26 Aug 2024
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • [1] Siegel RL, Miller KD, Jemal A: Cancer statistics, 20182018;68: 7-30. [2] 赫捷．2018 中国肿瘤登记年报［Ｍ］．北京：人民卫生出 版社，2019：129 [3] Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma [J]. N Engl J Med, 2007, 356(2): 115-124. [4] Escudier B, Szczylik C, Hutson T E, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma [J]. Journal of clinical oncology, 2009, 27(8): 1280-1289. [5] Motzer R J, Hutson T E, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma [J]. New England Journal of Medicine, 2007, 356(2): 115-24. [6] 韩雪冰.靶向联合免疫治疗提高晚期肾癌疗效[J].健康向导,2023,29(01):15. [7] 张凯,朱刚．2020 版 EAU 肾细胞癌诊疗指南更新解读 之二［J］．中华泌尿外科杂 2020， 41( 8) : 578-580． [8] 邓 建 华 , 纪 志 刚 . 高 危 肾 细 胞 癌 术 前 新 辅 助 靶 向 药 物 治 疗 [J]. 现 代 泌 尿 外 科 杂 志,2018,23(06):405-408. [9] 李凡,管维.肾癌诊疗相关进展[J].临床外科杂志,2021,29(02):101-104. [10] Bex A, van Thienen JV, Schrier M, et al. A Phase II, single-arm trial of neoadjuvant axitinib plus avelumab in patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (NEOAVAX) [published correction appears in Future Oncol. 2019 Aug;15(22):2667]. Future Oncol. 2019;15(19):2203-2209. [11] Karam JA, Msaouel P, Haymaker CL, Matin SF, Campbell MT, Zurita AJ, Shah AY, Wistuba II, Marmonti E, Duose DY, Parra ER, Soto LMS, Laberiano-Fernandez C, Lozano M, Abraham A, Hallin M, Chin CD, Olson P, Der-Torossian H, Yan X, Tannir NM, Wood CG. Phase II trial of neoadjuvant sitravatinib plus nivolumab in patients undergoing nephrectomy for locally advanced clear cell renal cell carcinoma. Nat Commun. 2023 May 10;14(1):2684.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cardonilizumab combined with renvastinib in people with Resectable Clear Cell Carcinoma of the Kidney, run by The First Hospital of Jilin University.

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 8 inclusion and 21 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 28 Aug 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ObjectiveResponse Rate，ORR (time frame: The proportion of patients whose tumor size reduction reaches predetermined limits and persists over). 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 NCT06574412, which also lists 1 linked publication.

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 28 Aug 2024.

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