New combo offers hope for kidney cancer patients who stopped responding to immunotherapy
NCT ID NCT06035224
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two drugs, cadonilimab and lenvatinib, in 28 adults with advanced clear cell kidney cancer that worsened after initial immunotherapy. The goal is to see if the combo can shrink tumors or slow disease progression. Participants receive treatment until their cancer progresses or side effects become too severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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28 people
The number who actually took part.
- Started
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Aug 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Criteria: Inclusion Criteria: 1. Written informed consent provided prior to study procedures. 2. Age ≥18 and ≤80 years at the time of consent. 3. Histologically or cytologically confirmed renal cell carcinoma with clear cell component. 4. Unresectable locally advanced or metastatic disease. 5. Radiographic disease progression during or after prior first-line immunotherapy-based combination therapy for advanced RCC. 6. At least one measurable lesion according to RECIST v1.1. 7. ECOG performance status of 0 or 1. 8. Estimated life expectancy of at least 3 months. 9. Adequate organ function, including hematologic, renal, hepatic, and coagulation parameters, as defined in the protocol. Exclusion Criteria: 1. History of hypersensitivity to monoclonal antibodies or any component of cadonilimab or lenvatinib. 2. Known additional malignancy that is progressing or has required active treatment. Exceptions include adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ. 3. Prior treatment with dual immune checkpoint blockade, defined as anti-PD-1/PD-L1 combined with anti-CTLA-4 therapy. 4. Uncontrolled clinically significant cardiovascular disease or symptoms. 5. Diagnosis of immunodeficiency or receipt of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to first dose. 6. Active autoimmune disease or history of autoimmune disease that may worsen with immunostimulatory therapy. Subjects with type 1 diabetes mellitus, vitiligo, psoriasis, or hypo-/hyperthyroidism not requiring immunosuppressive treatment are eligible. 7. History of non-infectious pneumonitis requiring steroids or current pneumonitis/interstitial lung disease. 8. Active tuberculosis or active syphilitic infection. 9. Known history of human immunodeficiency virus (HIV) infection. 10. Active hepatitis B infection (HBsAg positive with HBV DNA \>500 IU/mL) or active hepatitis C infection (detectable HCV RNA). 11. Clinically significant toxicities from prior anticancer therapy not recovered to Grade ≤1 (except alopecia or stable endocrinopathies). 12. Active bleeding disorder or history of clinically significant bleeding episodes. 13. Drug abuse, psychiatric illness, or medical/social conditions that may interfere with study participation or evaluation of results. 14. Pregnant or breastfeeding women, or participants planning conception during the study treatment period. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 200123, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill that starves tumors of oxygen help fight advanced cancer?