NCT06035224Active, not recruitingPhase 2
Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma
A Multicenter, Single-Arm, Phase II Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced/Metastatic Clear Cell Renal Cell Carcinoma Previously Treated With Immunotherapy-Based Combination Therapy
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
This is a phase II, open-label, multicenter, single-arm study evaluating the efficacy and safety of cadonilimab (AK104) in combination with lenvatinib in patients with unresectable advanced or metastatic clear cell renal cell carcinoma (ccRCC) who experienced disease progression during or after prior first-line immunotherapy-based combination therapy. Patients receive cadonilimab plus lenvatinib until radiographic disease progression, unacceptable toxicity, withdrawal of consent, death, or investigator decision. The primary endpoint is objective response rate (ORR) according to RECIST version 1.1 as assessed by investigators.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 6 Sept 2023
- Start date
- 23 Aug 2023
- Primary completion date
- 12 Jan 2026
- Lead sponsor
- RenJi Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT06035224
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 28
- From 23 Aug 2023 to the primary completion date, 12 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with dual immune checkpoint blockade, defined as anti-PD-1/PD-L1 combined with anti-CTLA-4 therapy.
- Diagnosis of immunodeficiency or receipt of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to first dose.
- Clinically significant toxicities from prior anticancer therapy not recovered to Grade ≤1 (except alopecia or stable endocrinopathies).
Other illness
- History of hypersensitivity to monoclonal antibodies or any component of cadonilimab or lenvatinib.
- 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.
- Uncontrolled clinically significant cardiovascular disease or symptoms.
- 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.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis/interstitial lung disease.
- Active tuberculosis or active syphilitic infection.
- Known history of human immunodeficiency virus (HIV) infection.
- Active hepatitis B infection (HBsAg positive with HBV DNA \>500 IU/mL) or active hepatitis C infection (detectable HCV RNA).
- Active bleeding disorder or history of clinically significant bleeding episodes.
- Drug abuse, psychiatric illness, or medical/social conditions that may interfere with study participation or evaluation of results.
Other
- Pregnant or breastfeeding women, or participants planning conception during the study treatment period.
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Criteria the registry did not label
- Criteria: Inclusion Criteria:
- Written informed consent provided prior to study procedures.
- Age ≥18 and ≤80 years at the time of consent.
- Histologically or cytologically confirmed renal cell carcinoma with clear cell component.
- Unresectable locally advanced or metastatic disease.
- Radiographic disease progression during or after prior first-line immunotherapy-based combination therapy for advanced RCC.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Estimated life expectancy of at least 3 months.
- Adequate organ function, including hematologic, renal, hepatic, and coagulation parameters, as defined in the protocol.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.