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Renal Cell Carcinoma (Kidney Cancer)Phase 2NCT07909265

Prospective Study of Cadonilimab With Lenvatinib in Renal Cell Carcinoma

A Phase 2 study testing Cadonilimab,Lenvatinib in people with Renal Cell Carcinoma (Kidney Cancer) and Clear Cell Renal Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, open, multi-cohort phase II study The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cadonilimab,Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
1 Apr 2025to 1 Mar 2028
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sign written informed consent before enrollment;
  • Age ≥18 years old;
  • Histological and/or cytological diagnosis of unresectable advanced renal cell carcinoma;
  • Cohort 1: renal clear cell carcinoma, mainly renal clear cell carcinoma, was included. Patients progressed after previous treatment with immune checkpoint inhibitor (ICI), and the number of previous treatment lines was less than 3;
  • Cohort 2: Non-transparent renal cell carcinoma was included. Subjects who had not received systematic treatment before or whose disease progressed after TKI or ICI treatment before could be included, with the number of previous treatment lines ≤3; They mainly included cohort A: papillary cell carcinoma, cohort B: chromophobe cell carcinoma, cohort C: collecting tubuloid carcinoma, cohort D: other types.
  • Consent to medical treatment;
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  • Understand and voluntarily sign written informed consent.
  • ECOG score: 0 ~ 1;
  • At least one measurable lesion (according to RECIST criteria, the length of CT scan for non-lymph node lesions ≥10 mm, and the short diameter of CT scan for lymph node lesions ≥15 mm);
  • Have adequate organ function:
  • Blood routine: Absolute Neutrophil Count (ANC) 1.5×10^9/L, Platelet (PLT) ≥70×10^9/L, Hemoglobin (HGB) ≥80g/L;
  • Liver function: Serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; After routine liver protection treatment, the patients could meet the above criteria and be stable for at least 1 week.
  • Kidney function: serum Creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/mi (using the standard Cockcroft-Gault formula) :
  • Coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT and INR are within the prescribed range of anticoagulants.
  • Estimated survival ≥3 months;
  • Use of a medically approved contraceptive method is required during the study treatment period and for at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.
  • Ability to adhere to research visit schedules and other protocol requirements.

Who cannot join

  • Poor patient compliance;
  • Subjects with any severe and/or uncontrolled disease. Includes:
  • Poor blood pressure control (systolic ≥150mmHg or diastolic ≥100mmHg); Poor diabetes control (fasting blood glucose [FBG] > 10mmol/L);
  • Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and grade ≥2 congestive heart failure (New York Heart Association [NYHA] grade);
  • Active or uncontrolled severe infections (≥CTCAE grade 2 infections) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis.
  • Active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥2000 IU/ml or ≥104 copy number /ml; Hepatitis C reference: HCV RNA≥2000 IU/ml or ≥104 copy number /ml; After nucleotide antiviral therapy, those who are lower than the above criteria can be included in the group); Chronic hepatitis B virus carriers, HBV DNA < 104 IU/ml, must also receive antiviral therapy during the trial to be enrolled;
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  • Renal failure requires hemodialysis or peritoneal dialysis;
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the initiation of study treatment, except for alternative therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency); Are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Dose > 10mg/ day of prednisone or other equivalent hormone and within 2 weeks of initial administration and continued use;
  • People with a history of active tuberculosis;
  • Failure to control, still need repeated drainage, ascites, pericardial effusion, pleural effusion;
  • Patients who have undergone major organ transplants;
  • Study participants who received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of treatment; Or have a wound or fracture that has not healed for a long time;
  • Patients with severe hypersensitivity after the use of monoclonal antibodies; Known allergy to the active ingredients or excipients of the drug in this study;
  • Participating in or having participated in other clinical investigators within 4 weeks prior to the start of the study;
  • People with a history of severe allergies;
  • At risk of bleeding, or coagulation dysfunction, or being treated with thrombolysis;
  • Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
  • Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons that are not suitable for enrollment. Have a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or predisposition to epilepsy;
  • If, in the investigator's judgment, there is a concomitant medical condition (such as serious diabetes, thyroid disease, and mental illness) that seriously endangers the subject's safety or prevents the subject from completing the study, or there is a serious and/or unstable medical, mental or other condition (including abnormal laboratory tests) that affects the patient's safety or prevents the patient from providing informed consent, Or the presence of any psychological, familial, sociological or geographical conditions that affect the study protocol and follow-up plan;
  • The investigator considers it inappropriate to participate in the clinical trial for any reason;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiongjun Ye, Ph.D contact

13910380916

yexiongjun@cicams.ac.cn

China1 site, 1 recruiting

  • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Panjiayuan Nanli, 100021

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open, Multi-cohort Study of Cadonilimab Combined With Lenvatinib in Renal Cell Carcinoma

This is a prospective, open, multi-cohort phase II study The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up).

Screening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility.

Read more

Duration of treatment: Patients were treated with Cadonilimab in combination with lenvatinib until disease progression or intolerable toxicity developed. Every 3 weeks was a dosing cycle, and every 6 weeks was a treatment assessment.

Follow-up period: The safety follow-up period began after the last study treatment, and was followed up once on the 30th day (±7 days). Subjects should go to the research center for the examination of vital signs, physical examination, laboratory examination and other protocol requirements, and evaluate AE, concomitant medication and concomitant treatment.

After the end of the safety follow-up period, the subjects entered the 1-year survival follow-up period, which was conducted every 3 months. They could be visited by telephone follow-up and other effective ways to collect survival information and follow-up treatment information. Survival follow-up lasted until death, loss of follow-up, withdrawal

Being tested
Cadonilimab,Lenvatinib
Keywords
Renal cell carcinoma, Cadonilimab, Lenvatinib, PD-1/CTLA-4 Bispecific Antibody
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

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

  • Cadonilimab,LenvatinibDrug

    When toxic and side effects occur during the study, the investigator can use active symptomatic supportive treatment, and the study drug can be suspended, downdosed and terminated according to the toxic and side effects of the study drug. Suspension of the study drug is allowed during the study period.

Study groups in NCT07909265
Study groupRoleWhat they receive
clear cell carcinomaExperimentalNot described
Receives: Drug: Cadonilimab,Lenvatinib
Non-clear cell carcinomaExperimentalNot described
Receives: Drug: Cadonilimab,Lenvatinib

What is being measured

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

  1. Objective Response Rate(ORR)

    Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) according to RECIST V1.1 criteria.

    Measured: Every 6 weeks (±5 days) from first dose (C1D1) until disease progression or end of treatment, assessed up to approximately 24 months.

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    Time from date of first dose to the first documented disease progression per RECIST V1.1 or death from any cause.

    Measured: Tumor assessments every 6 weeks (±5 days) until progression, death, or end of follow-up, assessed up to approximately 24 months.

  2. Overall Survival (OS)

    Time from date of first dose to death from any cause.

    Measured: Every 3 months via telephone from first dose until death or end of follow-up, assessed up to approximately 36 months.

  3. Disease Control Rate (DCR)

    Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST V1.1 criteria.

    Measured: Every 6 weeks (±5 days) from first dose until disease progression or end of treatment, assessed up to approximately 24 months.

  4. Duration of Response (DoR)

    Time from first documented CR or PR to first documented disease progression or death.

    Measured: From first documented response, assessed every 6 weeks (±5 days) until progression or death, up to approximately 24 months.

  5. Quality of Life assessed by EORTC QLQ-C30

    Change in disease-related symptoms and health-related quality of life (HRQoL) assessed by the EORTC QLQ-C30 questionnaire.

    Measured: At screening, every 6 weeks during treatment, and at end of treatment, assessed up to approximately 24 months.

Timeline

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

  1. First posted2 Nov 2026
  2. Study start1 Apr 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Mar 2028 (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
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909265
Sponsor's protocol ID
NCC4708
Status last verified
Oct 2026
First submitted
17 Feb 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Zheng RS, Chen R, Han BF, Wang SM, Li L, Sun KX, Zeng HM, Wei WW, He J. [Cancer incidence and mortality in China, 2022]. Zhonghua Zhong Liu Za Zhi. 2024 Mar 23;46(3):221-231. doi: 10.3760/cma.j.cn112152-20240119-00035. Chinese.

    PubMed 38468501

  • Moch H, Gasser T, Amin MB, Torhorst J, Sauter G, Mihatsch MJ. Prognostic utility of the recently recommended histologic classification and revised TNM staging system of renal cell carcinoma: a Swiss experience with 588 tumors. Cancer. 2000 Aug 1;89(3):604-14.

    PubMed 10931460

  • Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M, Larkin J, Lorigan P, Neyns B, Blank CU, Hamid O, Mateus C, Shapira-Frommer R, Kosh M, Zhou H, Ibrahim N, Ebbinghaus S, Ribas A; KEYNOTE-006 investigators. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015 Jun 25;372(26):2521-32. doi: 10.1056/NEJMoa1503093. Epub 2015 Apr 19.

    PubMed 25891173

  • Sharma P, Siddiqui BA, Anandhan S, Yadav SS, Subudhi SK, Gao J, Goswami S, Allison JP. The Next Decade of Immune Checkpoint Therapy. Cancer Discov. 2021 Apr;11(4):838-857. doi: 10.1158/2159-8290.CD-20-1680.

    PubMed 33811120

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

    PubMed 28885881

  • Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.

    PubMed 32945632

  • Atkins MB, Plimack ER, Puzanov I, Fishman MN, McDermott DF, Cho DC, Vaishampayan U, George S, Olencki TE, Tarazi JC, Rosbrook B, Fernandez KC, Lechuga M, Choueiri TK. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018 Mar;19(3):405-415. doi: 10.1016/S1470-2045(18)30081-0. Epub 2018 Feb 10.

    PubMed 29439857

  • Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

    PubMed 33246931

  • Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, Grunwald V, Hutson TE, Kopyltsov E, Mendez-Vidal MJ, Kozlov V, Alyasova A, Hong SH, Kapoor A, Alonso Gordoa T, Merchan JR, Winquist E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer A, Procopio G, Takagi T, Melichar B, Rolland F, De Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Apr 8;384(14):1289-1300. doi: 10.1056/NEJMoa2035716. Epub 2021 Feb 13.

    PubMed 33616314

  • Powles T, Plimack ER, Soulieres D, Waddell T, Stus V, Gafanov R, Nosov D, Pouliot F, Melichar B, Vynnychenko I, Azevedo SJ, Borchiellini D, McDermott RS, Bedke J, Tamada S, Yin L, Chen M, Molife LR, Atkins MB, Rini BI. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1563-1573. doi: 10.1016/S1470-2045(20)30436-8. Epub 2020 Oct 23.

    PubMed 33284113

  • Motzer RJ, Powles T, Burotto M, Escudier B, Bourlon MT, Shah AY, Suarez C, Hamzaj A, Porta C, Hocking CM, Kessler ER, Gurney H, Tomita Y, Bedke J, Zhang J, Simsek B, Scheffold C, Apolo AB, Choueiri TK. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):888-898. doi: 10.1016/S1470-2045(22)00290-X. Epub 2022 Jun 7.

    PubMed 35688173

  • Motzer RJ, Powles T, Atkins MB, Escudier B, McDermott DF, Alekseev BY, Lee JL, Suarez C, Stroyakovskiy D, De Giorgi U, Donskov F, Mellado B, Banchereau R, Hamidi H, Khan O, Craine V, Huseni M, Flinn N, Dubey S, Rini BI. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma. JAMA Oncol. 2022 Feb 1;8(2):275-280. doi: 10.1001/jamaoncol.2021.5981.

    PubMed 34940781

  • Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.

    PubMed 16757724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab,Lenvatinib in people with Renal Cell Carcinoma (Kidney Cancer) and Clear Cell Renal Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

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 17 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Xiongjun Ye, Ph.D (13910380916, yexiongjun@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: Every 6 weeks (±5 days) from first dose (C1D1) until disease progression or end of treatment, assessed up to approximately 24 months.). 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 NCT07909265, which also lists 18 linked publications.

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 2 Nov 2026.

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