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Non-Clear Cell Renal Cell CarcinomaPhase 3NCT07881900

Benmelstobart Plus Anlotinib Versus Sunitinib as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma

A Phase 3 study testing Benmelstobart, Anlotinib and Sunitinib in people with Non-Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University 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 study will compare benmelstobart plus anlotinib with sunitinib as the first treatment for adults with advanced non-clear cell renal cell carcinoma, a type of kidney cancer. Eligible participants have cancer that cannot be removed surgically, has returned locally, or has spread to other parts of the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Clear Cell Renal Cell Carcinoma
What is being tested?
Benmelstobart, Anlotinib and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
1 Jun 2025to 30 Jun 2029
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Voluntary participation with signed informed consent and willingness to comply with study procedures.
  • 2. Age 18 years or older. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of at least 3 months.
  • 4. Histologically confirmed advanced non-clear cell renal cell carcinoma, including papillary or unclassified renal cell carcinoma, but excluding chromophobe renal cell carcinoma, collecting duct carcinoma, and renal medullary carcinoma. Advanced disease includes stage IV, unresectable, locally recurrent, or metastatic disease. Tumors with a predominantly non-clear cell component are eligible.
  • 5. At least one measurable lesion according to RECIST 1.1. 6. Adequate organ function, defined as:
  • Hemoglobin >=80 g/L.
  • Absolute neutrophil count >=1.5 x 10^9/L.
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  • White blood cell count >=3.5 x 10^9/L.
  • Platelet count >=80 x 10^9/L.
  • Alanine aminotransferase and aspartate aminotransferase <=2.5 times the upper limit of normal (ULN), or <=5 times ULN in participants with liver or bone metastases.
  • Total bilirubin <=1.5 times ULN.
  • Serum creatinine <=1.5 times ULN or creatinine clearance >=60 mL/min.
  • Activated partial thromboplastin time, international normalized ratio, and prothrombin time <=1.5 times ULN.
  • 7. Women of childbearing potential must be confirmed not pregnant before enrollment. All participants must use adequate contraception throughout treatment and for 4 weeks after treatment ends.

Who cannot join

  • 1. Chromophobe renal cell carcinoma, collecting duct carcinoma, or renal medullary carcinoma.
  • 2. Known hypersensitivity to benmelstobart, anlotinib, sunitinib, or any excipient of the study drugs.
  • 3. Antitumor monoclonal antibody therapy or other investigational drug treatment within 4 weeks before enrollment; prior systemic anti-PD-1 or anti-PD-L1 treatment for metastatic disease.
  • 4. Prior anlotinib, sunitinib, or other systemic antiangiogenic therapy for metastatic disease.
  • 5. Use of immunosuppressive agents or systemic corticosteroids for immunosuppression at doses greater than 10 mg/day of prednisone or equivalent within 2 weeks before enrollment.
  • 6. Active autoimmune disease or a history of autoimmune disease. 7. Congenital or acquired immunodeficiency. 8. Local radiotherapy within 4 weeks before enrollment. 9. Gastrointestinal perforation or major surgery within 4 weeks before enrollment. Diagnostic biopsy and placement of a peripherally inserted central catheter or infusion port are permitted.
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  • 10. Arterial or venous thromboembolic events within 6 months before enrollment or randomization, including cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism. Prior catheter-related thrombosis associated with chemotherapy may be permitted if considered resolved by the investigator.
  • 11. Active bleeding or a bleeding tendency, including clinically significant hemoptysis greater than 50 mL/day within 3 months before enrollment, gastrointestinal bleeding, bleeding gastric ulcer, positive baseline fecal occult blood, or vasculitis.
  • 12. Urine protein >=2+ requires assessment of 24-hour urinary protein. Participants must meet the protocol requirements for urinary protein excretion.
  • 13. Corrected QT interval >470 milliseconds. Participants whose QT prolongation is attributed to a pacemaker, without other cardiac abnormalities, require discussion with the sponsor's study physician before eligibility is determined.
  • 14. Suspected additional primary cancer or an uncured malignancy within the previous 5 years, except clearly cured or curable malignancies such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, breast carcinoma in situ, or localized low-risk prostate cancer. Participants with prostate cancer meeting the protocol criteria of stage <=T2b, Gleason score <=7, and prostate-specific antigen <=20 ng/mL, if measured, may participate after definitive treatment without biochemical recurrence.
  • 15. Hypertension not adequately controlled with medication, defined as systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg.
  • 16. Myocardial infarction, severe or unstable angina, cardiac dysfunction above New York Heart Association class II, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure within 6 months before randomization.
  • 17. Interstitial lung disease, noninfectious pneumonitis, or uncontrolled systemic disease, including uncontrolled diabetes, pulmonary fibrosis, or acute pneumonia.
  • 18. Live attenuated vaccination within 28 days before the first study dose or planned live attenuated vaccination during the study.
  • 19. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome; active hepatitis B, defined as HBV DNA >=500 IU/mL; active hepatitis C, defined as HCV RNA above the assay detection limit; or concurrent hepatitis B and hepatitis C infection.
  • 20. Severe infection within 4 weeks before the first study dose, including bacteremia or severe pneumonia requiring hospitalization; an active infection of CTCAE grade >=2 requiring systemic antibiotics within 2 weeks before the first dose; or unexplained fever >38.5 degrees Celsius during screening or before the first dose, unless considered tumor-related by the investigator. Evidence of active tuberculosis within 1 year before the first dose.
  • 21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation.
  • 22. Peripheral neuropathy of grade >=2. 23. Active brain metastases, carcinomatous meningitis, spinal cord compression, or brain or leptomeningeal disease identified on screening imaging. Treated brain metastases may be eligible if treatment was completed at least 14 days before enrollment, symptoms are stable, and imaging confirms no intracranial hemorrhage.
  • 24. Conditions significantly affecting oral drug absorption, including inability to swallow, chronic diarrhea, or clinically significant intestinal obstruction.
  • 25. Pregnancy, breastfeeding, or planned pregnancy during the study. 26. Other serious physical or psychiatric illness, laboratory abnormalities, or circumstances that may increase study-related risk, interfere with study results, or make participation inappropriate in the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomized, Controlled, Prospective, Multicenter, Phase III Study of Benmelstobart Plus Anlotinib Versus Sunitinib as First-Line Treatment for Advanced Non-Clear Cell Renal Cell Carcinoma

This study will compare benmelstobart plus anlotinib with sunitinib as the first treatment for adults with advanced non-clear cell renal cell carcinoma, a type of kidney cancer. Eligible participants have cancer that cannot be removed surgically, has returned locally, or has spread to other parts of the body. Patients with chromophobe, collecting duct, or renal medullary carcinoma are not eligible.

Benmelstobart is an immunotherapy that blocks PD-L1, a protein involved in suppressing the immune response to cancer. Anlotinib and sunitinib are targeted medicines that inhibit signals involved in tumor growth and blood vessel formation.

Read more

The study plans to enroll 126 participants at multiple centers. Participants will be randomly assigned in a 2:1 ratio to receive either benmelstobart plus anlotinib or sunitinib. Participants and study doctors will know which treatment is assigned.

The main purpose is to compare how long participants live without their cancer getting worse. The study will also assess tumor response, overall survival, side effects, and quality of life.

Read the detailed description

This is a prospective, randomized, open-label, parallel-group, multicenter Phase III study evaluating the efficacy and safety of benmelstobart plus anlotinib versus sunitinib as first-line treatment for advanced non-clear cell renal cell carcinoma.

A total of 126 participants are planned, with 84 assigned to benmelstobart plus anlotinib and 42 assigned to sunitinib. Eligible participants are adults with histologically confirmed advanced non-clear cell renal cell carcinoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Chromophobe renal cell carcinoma, collecting duct carcinoma, and renal medullary carcinoma are excluded.

Participants in the experimental group will receive benmelstobart 1200 mg intravenously every 3 weeks plus anlotinib 12 mg orally once daily on days 1 through 14 of each 21-day cycle. Participants in the control group will receive sunitinib 50 mg orally once daily on days 1 through 28 of each 42-day cycle. Treatment interruptions, dose modifications, and discontinuation will follow the protocol.

The primary endpoint is progression-free survival. Secondary assessments include overall survival, objective response rate, disease control rate, duration of response, quality of life, and safety. Tumor response will be assessed using RECIST 1.1, with additional immune-related response assessments using iRECIST in the experimental group. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Exploratory biomarker analyses are planned to examine associations between treatment outcomes and tumor or blood-based markers, including PD-L1 expression, tumor mutational burden, genomic alterations, and gene expression profiles.

Being tested
Benmelstobart, Anlotinib, Sunitinib
Keywords
Advanced Non-Clear Cell Renal Cell Carcinoma, Benmelstobart, Anlotinib, Sunitinib, First-Line Treatment

What participants receive

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

  • BenmelstobartDrug

    1200 mg administered by intravenous infusion on day 1 of each 21-day cycle.

  • AnlotinibDrug

    12 mg administered orally once daily on days 1 through 14 of each 21-day cycle, followed by 7 days without anlotinib. Dose modifications will follow the protocol.

  • SunitinibDrug

    50 mg administered orally once daily on days 1 through 28 of each 42-day cycle, followed by 14 days without sunitinib. Dose modifications will follow the protocol.

Study groups in NCT07881900
Study groupRoleWhat they receive
Benmelstobart Plus AnlotinibExperimentalParticipants will receive benmelstobart 1200 mg by intravenous infusion on day 1 of each 21-day cycle plus anlotinib 12 mg orally once daily on days 1 through 14 of each 21-day cycle. Treatment interruptions, dose modifications, and discontinuation will follow the protocol.
Receives: Drug: Benmelstobart; Drug: Anlotinib
SunitinibActive comparatorParticipants will receive sunitinib 50 mg orally once daily on days 1 through 28 of each 42-day cycle, followed by 14 days without sunitinib. Treatment interruptions, dose modifications, and discontinuation will follow the protocol.
Receives: Drug: Sunitinib

What is being measured

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

  1. Progression-Free Survival (PFS)

    Time from randomization to the first documented disease progression according to RECIST 1.1 or death from any cause, whichever occurs first.

    Measured: From randomization to disease progression or death, whichever occurs first, assessed up to 48 months.

Timeline

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

  1. First posted20 Oct 2026
  2. Study start1 Jun 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 2:1 ratio to receive benmelstobart plus anlotinib or sunitinib in two parallel groups. Planned enrollment is 126 participants: 84 in the combination group and 42 in the sunitinib group.
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07881900
Sponsor's protocol ID
2025-FXY-176
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benmelstobart, Anlotinib and Sunitinib in people with Non-Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University 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 13 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-Free Survival (PFS) (time frame: From randomization to disease progression or death, whichever occurs first, assessed up to 48 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 NCT07881900.

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 20 Oct 2026.

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