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Clear Cell Renal Cell CarcinomaPhase 2NCT06035224

Cadonilimab (AK104) Plus Lenvatinib in Previously Immunotherapy-Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma

A Phase 2 study testing AK104（anti-PD-1/CTLA-4 bi-specific antibody ，intravenously）,lenvatinib（ targeted VEGFR 1-3、FGFR、PDGFRα， small molecule TKI，orally in people with Clear Cell Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
AK104（anti-PD-1/CTLA-4 bi-specific antibody ，intravenously）,lenvatinib（ targeted VEGFR 1-3、FGFR、PDGFRα， small molecule TKI，orally
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
23 Aug 2023to 31 Oct 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
  • Prior treatment with dual immune checkpoint blockade, defined as anti-PD-1/PD-L1 combined with anti-CTLA-4 therapy.
  • Uncontrolled clinically significant cardiovascular disease or symptoms.
  • Diagnosis of immunodeficiency or receipt of systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to first dose.
  • 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.
Show all 15Show fewer
  • 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).
  • Clinically significant toxicities from prior anticancer therapy not recovered to Grade ≤1 (except alopecia or stable endocrinopathies).
  • 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.
  • Pregnant or breastfeeding women, or participants planning conception during the study treatment period.
  • -

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Renji Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is a multicenter, open-label, single-arm phase II clinical trial with a planned enrollment of 28 patients with unresectable advanced or metastatic clear cell renal cell carcinoma (ccRCC). Participating centers include Renji Hospital and Ruijin Hospital in Shanghai, China.

Patients receive oral lenvatinib at a starting dose of:

8 mg once daily for body weight <60 kg 12 mg once daily for body weight ≥60 kg Cadonilimab (AK104) is administered intravenously at 10 mg/kg every 3 weeks. Treatment continues until radiographic disease progression, unacceptable toxicity, withdrawal of informed consent, initiation of new anticancer therapy, death, loss to follow-up, or investigator decision.

Tumor assessments are performed at baseline, every 6 weeks (±7 days) during treatment, and at the end-of-treatment visit.

This study uses Simon's optimal two-stage phase II design. In stage 1, 12 evaluable patients are enrolled for futility assessment. If 2 or fewer confirmed objective responses are observed, the study may be terminated early for futility. Otherwise, enrollment proceeds to a total of 28 evaluable patients.

The study is designed to assess whether cadonilimab plus lenvatinib demonstrates sufficient antitumor activity to warrant further clinical investigation in patients with advanced ccRCC previously treated with immunotherapy-based therapy.

Being tested
AK104（anti-PD-1/CTLA-4 bi-specific antibody ，intravenously）,lenvatinib（ targeted VEGFR 1-3、FGFR、PDGFRα， small molecule TKI，orally
Keywords
Clear cell renal cell carcinoma, Immunotherapy rechallenge, Tyrosine kinase inhibitor, PD-1/CTLA-4 bispecific antibody
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • AK104（anti-PD-1/CTLA-4 bi-specific antibody ，intravenously）,lenvatinib（ targeted VEGFR 1-3、FGFR、PDGFRα， small molecule TKI，orallyDrug

    AK104 (10mg/kg ,Q3W，intravenously) plus lenvatinib(<60kg，8 mg qd；≥60kg，12mg qd, orally.

Study groups in NCT06035224
Study groupRoleWhat they receive
AK104 combine with lenvatinibExperimentalPatients will receive AK104 (10mg/kg ,Q3W，intravenously) plus lenvatinib(<60kg，8 mg qd；≥60kg，12mg qd, orally.
Receives: Drug: AK104（anti-PD-1/CTLA-4 bi-specific antibody ，intravenously）,lenvatinib（ targeted VEGFR 1-3、FGFR、PDGFRα， small molecule TKI，orally

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 confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by investigators.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Duration of response (DOR)

    Time from first documented objective response to disease progression or death.

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD)

    Measured: Up to 2 years

  3. Time to response（TTR）

    Time from treatment initiation to first documented objective response.

    Measured: Up to 2 years

  4. Progression-free survival (PFS)

    Time from treatment initiation to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to 2 years

  5. Overall survival (OS)

    Time from treatment initiation until death from any cause.

    Measured: Up to 2 years

  6. Adverse event

    Incidence, type, and severity of treatment-emergent adverse events graded per CTCAE v5.0.

    Measured: Up to 2 years

Timeline

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

  1. First posted13 Sep 2023
  2. Study start23 Aug 2023
  3. Primary completion12 Jan 2026
  4. Study completion31 Oct 2026 (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
Model description
Patients receive oral lenvatinib at a starting dose of: 8 mg once daily for body weight \<60 kg 12 mg once daily for body weight ≥60 kg Cadonilimab (AK104) is administered intravenously at 10 mg/kg every 3 weeks. Treatment continues until radiographic disease progression, unacceptable toxicity, withdrawal of informed consent, initiation of new anticancer therapy, death, loss to follow-up, or investigator decision.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06035224
Sponsor's protocol ID
CLEAR-IT
Status last verified
May 2026
First submitted
6 Sep 2023
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104（anti-PD-1/CTLA-4 bi-specific antibody ，intravenously）,lenvatinib（ targeted VEGFR 1-3、FGFR、PDGFRα， small molecule TKI，orally in people with Clear Cell Renal Cell Carcinoma, run by RenJi Hospital 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 0 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 19 May 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?

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?

Objective Response Rate (ORR) (time frame: Up to 2 years). 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 NCT06035224.

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 19 May 2026.

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