Renal Cell Carcinoma (Kidney Cancer)Phase 2NCT07715565
Ipilimumab N01 Plus Sintilimab and Lenvatinib as First-line Therapy for Locally Advanced or Metastatic TFE3-Rearranged Renal Cell Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial
A Phase 2 study testing Ipilimumab Injection, Sintilimab injection and Lenvatinib in people with Renal Cell Carcinoma (Kidney Cancer) and Immunotherapy, run by West China Hospital at 1 site in China.
Trial summary
This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer), Immunotherapy, Molecular Targeted Therapy
- What is being tested?
- Ipilimumab Injection, Sintilimab injection and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2029
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥14 years, any gender.
- Histologically confirmed locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC) by FISH and/or next-generation sequencing.
- Stage IV disease per the 2017 8th edition TNM staging system.
- No prior systemic therapy with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) or targeted agents (TKI, mTORi); prior targeted therapy ≤1 month is allowed after an adequate washout (5.5 half-lives).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy ≥3 months.
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- Signed informed consent and ability to comply with study visits and procedures.
- Willingness to provide tumor tissue and blood specimens for correlative studies.
- Adequate organ and bone marrow function within 14 days prior to enrollment:
- Hematology: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. Hepatic: TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, albumin ≥20 g/L. Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min.
Who cannot join
- Active central nervous system metastases.
- History of other malignancies within 3 years (different primary site or histology), except well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.
- Major surgery or severe trauma within 4 weeks prior to enrollment.
- Systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days before first dose (topical, ophthalmic, intra-articular, intranasal, inhaled, or physiologic replacement steroids are permitted).
- Known or suspected active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis), except type 1 diabetes, hypothyroidism requiring hormone replacement only, or skin conditions not requiring systemic treatment. Known allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.
- Known hypersensitivity to ipilimumab N01, sintilimab, or lenvatinib.
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- Uncontrolled severe comorbidities including:
- Active or poorly controlled severe infection. HIV infection. Active hepatitis B (HBsAg-positive and HBV DNA >1×10³ IU/mL) or active hepatitis C (HCV antibody-positive and HCV RNA >15 IU/mL).
- Active pulmonary tuberculosis. New York Heart Association Class III-IV congestive heart failure, symptomatic arrhythmia, uncontrolled atrial fibrillation, or left ventricular ejection fraction below the lower limit of normal.
- Uncontrolled arterial hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg). Arterial thrombosis, embolism, or ischemia within 6 months (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack).
- Uncontrolled adrenal insufficiency. Severe, non-healing wounds or ulcers; gastrointestinal disorders impairing absorption; active uncontrolled bleeding or high bleeding risk (e.g., esophageal/gastric varices requiring intervention); or unstable anticoagulation with clinically significant bleeding.
- Any other acute or chronic medical or psychiatric condition, or laboratory abnormality, that in the opinion of the investigator increases the risk associated with study participation, may interfere with interpretation of study results, or makes the patient unsuitable for the study.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Chengdu, Sichuan 610000
Chengdu
Xingming Zhang, Doctor, +86-18782258490, Jarmin@scu.edu.cn
About this study
This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Eligible patients (age ≥14 years, ECOG ≤2, measurable disease per RECIST v1.1, no prior systemic therapy) will receive ipilimumab N01 1 mg/kg Q6W for 4 cycles, sintilimab 200 mg Q3W for up to 35 cycles, and lenvatinib 12 mg or 8 mg QD continuously. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety per NCI CTCAE v5.0, and quality of life. Exploratory biomarker analyses will assess potential predictors of treatment response.
Read the detailed description
This prospective, multicenter, single-arm, open-label, phase II clinical trial evaluates the efficacy and safety of first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC). TFE3-rRCC is a rare, aggressive renal cell carcinoma subtype with no established standard first-line systemic therapy. Preliminary retrospective data suggest that immune checkpoint inhibitor-based combination therapy may improve clinical outcomes in this population.
Eligible patients (age ≥14 years; ECOG performance status ≤2) must have histologically confirmed, locally advanced or metastatic TFE3-rRCC diagnosed by fluorescence in situ hybridization (FISH) and/or next-generation sequencing, with measurable disease per RECIST v1.1, and no prior systemic therapy (or prior targeted therapy ≤1 month with adequate washout). A total of 66 participants will be enrolled using a Simon two-stage optimal design (21 patients in stage 1; 39 in stage 2).
Participants will receive ipilimumab N01 1 mg/kg intravenously every 6 weeks for the first 4 cycles (induction); sintilimab 200 mg intravenously every 3 weeks for up to 35 cycles (approximately 2 years); and lenvatinib 12 mg (body weight ≥60 kg) or 8 mg (body weight <60 kg) orally once daily continuously until disease progression, unacceptable toxicity, or loss of clinical benefit.
The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST v1.1. Secondary endpoints include disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), cancer-specific survival (CSS), ORR and DCR per imRECIST, safety profile according to NCI CTCAE v5.0, and quality of life measured by EORTC QLQ-C30, FKSI-DRS, EuroQOL, and VAS. Exploratory analyses will evaluate biomarkers (tumor tissue PD-1, PD-L1, CD4, CD8, tumor-infiltrating lymphocytes, tumor mutational burden; peripheral blood cytokines, circulating tumor DNA, immune cell subsets by single-cell sequencing) and functional MRI sequences as potential predictors of treatment response.
- Being tested
- Ipilimumab Injection, Sintilimab injection, Lenvatinib
- Keywords
- Sintilimab, ipilimumab, lenvatinib
- 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.
Ipilimumab InjectionDrug
Also called Ipilimumab
A human monoclonal antibody targeting CTLA-4.
Sintilimab injectionDrug
Also called Sintilimab
Recombinant human-derived immunoglobulin G (IgG4)-type anti-programmed cell death receptor-1 (PD-1) monoclonal antibody, by binding to PD-1 and blocking PD-1 binding to PD-L1 and PD-L2, disarms the immunosuppressive effect, activates T-cell function, and enhances T-cell immunosurveillance and killing ability against tumors to generate tumor immune response.
LenvatinibDrug
A multi-target tyrosine kinase inhibitor (VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET).
| Study group | Role | What they receive |
|---|---|---|
| Combination treatment group | Experimental | Participants receive ipilimumab 1 mg/kg intravenously every 6 weeks for the first 4 cycles (induction phase) in combination with sintilimab 200 mg intravenously every 3 weeks for up to 35 cycles (approximately 2 years), plus lenvatinib 12 mg (body weight ≥60 kg) or 8 mg (body weight <60 kg) orally once daily continuously until disease progression, unacceptable toxicity, or loss of clinical benefit. Receives: Drug: Ipilimumab Injection; Drug: Sintilimab injection; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1.
Measured: 3 years
Secondary outcomes (10)
Adverse Events (AEs)
Adverse events are the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including type and severity.
Measured: 3 years
Overall Survival (OS)
Overall survival is the time from starting treatment to still being alive.
Measured: 3 years
Progression-Free Survival (PFS)
Progression-free survival is assessed by investigators based on RECIST1.1, including disease progression or death from any cause.
Measured: 3 years
Disease Control Rate (DCR)
Disease control rate is the proportion of participates with complete response (CR), partial response (PR) or stable disease (SD), based on RECIST1.1.
Measured: 3 years
Duration of Response (DoR)
Duration of response is the time from first response (complete or partial response) to disease progression or death.
Measured: 3 years
Cancer-Specific Survival (CSS)
The period from the time the patient was diagnosed with the tumor or began treatment until death directly caused by the tumor
Measured: 3 years
Quality of Life, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30（EORTC QLQ-C30）
Used to assess the multi-dimensional impact of cancer treatment on the quality of life of patients
Measured: 3 years
Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms （FKSI-DRS）
Used to assess the impact of specific symptoms related to kidney cancer on quality of life
Measured: 3 years
European Quality of Life （EuroQOL）
Used to assess the current overall health status of the patient
Measured: 3 years
Visual Analogue Scale（VAS）
Used to assess the pain condition and severity of the patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Zeng, West China Hospital
- Investigators
- Hao Zeng, Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715565
- Sponsor's protocol ID
- LIST
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ipilimumab N01 Plus Sintilimab and Lenvatinib as First-line Therapy for Locally Advanced or Metastatic TFE3-Rearranged Renal Cell Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07715565
- Acronym / sponsor ID
- LIST
- Keywords
- Sintilimab, ipilimumab, lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Eligible patients (age ≥14 years, ECOG ≤2, measurable disease per RECIST v1.1, no prior systemic therapy) will receive ipilimumab N01 1 mg/kg Q6W for 4 cycles, sintilimab 200 mg Q3W for up to 35 cycles, and lenvatinib 12 mg or 8 mg QD continuously. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety per NCI CTCAE v5.0, and quality of life. Exploratory biomarker analyses will assess potential predictors of treatment response.
Detailed description
This prospective, multicenter, single-arm, open-label, phase II clinical trial evaluates the efficacy and safety of first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC). TFE3-rRCC is a rare, aggressive renal cell carcinoma subtype with no established standard first-line systemic therapy. Preliminary retrospective data suggest that immune checkpoint inhibitor-based combination therapy may improve clinical outcomes in this population.
Eligible patients (age ≥14 years; ECOG performance status ≤2) must have histologically confirmed, locally advanced or metastatic TFE3-rRCC diagnosed by fluorescence in situ hybridization (FISH) and/or next-generation sequencing, with measurable disease per RECIST v1.1, and no prior systemic therapy (or prior targeted therapy ≤1 month with adequate washout). A total of 66 participants will be enrolled using a Simon two-stage optimal design (21 patients in stage 1; 39 in stage 2).
Participants will receive ipilimumab N01 1 mg/kg intravenously every 6 weeks for the first 4 cycles (induction); sintilimab 200 mg intravenously every 3 weeks for up to 35 cycles (approximately 2 years); and lenvatinib 12 mg (body weight ≥60 kg) or 8 mg (body weight <60 kg) orally once daily continuously until disease progression, unacceptable toxicity, or loss of clinical benefit.
The primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST v1.1. Secondary endpoints include disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), cancer-specific survival (CSS), ORR and DCR per imRECIST, safety profile according to NCI CTCAE v5.0, and quality of life measured by EORTC QLQ-C30, FKSI-DRS, EuroQOL, and VAS. Exploratory analyses will evaluate biomarkers (tumor tissue PD-1, PD-L1, CD4, CD8, tumor-infiltrating lymphocytes, tumor mutational burden; peripheral blood cytokines, circulating tumor DNA, immune cell subsets by single-cell sequencing) and functional MRI sequences as potential predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination treatment group | Experimental | Drug: Ipilimumab Injection, Drug: Sintilimab injection, Drug: LenvatinibParticipants receive ipilimumab 1 mg/kg intravenously every 6 weeks for the first 4 cycles (induction phase) in combination with sintilimab 200 mg intravenously every 3 weeks for up to 35 cycles (approximately 2 years), plus lenvatinib 12 mg (body weight ≥60 kg) or 8 mg (body weight <60 kg) orally once daily continuously until disease progression, unacceptable toxicity, or loss of clinical benefit. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥14 years, any gender.
- Histologically confirmed locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC) by FISH and/or next-generation sequencing.
- Stage IV disease per the 2017 8th edition TNM staging system.
- No prior systemic therapy with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) or targeted agents (TKI, mTORi); prior targeted therapy ≤1 month is allowed after an adequate washout (5.5 half-lives).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Key exclusion criteria (13 listed)
- Active central nervous system metastases.
- History of other malignancies within 3 years (different primary site or histology), except well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.
- Major surgery or severe trauma within 4 weeks prior to enrollment.
- Systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days before first dose (topical, ophthalmic, intra-articular, intranasal, inhaled, or physiologic replacement steroids are permitted).
- Known or suspected active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis), except type 1 diabetes, hypothyroidism requiring hormone replacement only, or skin conditions not requiring systemic treatment. Known allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipilimumab InjectionAlso: IpilimumabA human monoclonal antibody targeting CTLA-4. | Drug | Combination treatment group |
| Sintilimab injectionAlso: SintilimabRecombinant human-derived immunoglobulin G (IgG4)-type anti-programmed cell death receptor-1 (PD-1) monoclonal antibody, by binding to PD-1 and blocking PD-1 binding to PD-L1 and PD-L2, disarms the immunosuppressive effect, activates T-cell function, and enhances T-cell immunosurveillance and killing ability against tumors to generate tumor immune response. | Drug | Combination treatment group |
| LenvatinibA multi-target tyrosine kinase inhibitor (VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET). | Drug | Combination treatment group |
Primary outcome
Objective Response Rate (ORR)
Time frame: 3 years
Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1.
10 secondary outcomes
Adverse Events (AEs)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Progression-Free Survival (PFS)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Duration of Response (DoR)
Time frame: 3 years
Cancer-Specific Survival (CSS)
Time frame: 3 years
Quality of Life, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30（EORTC QLQ-C30）
Time frame: 3 years
Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms （FKSI-DRS）
Time frame: 3 years
European Quality of Life （EuroQOL）
Time frame: 3 years
Visual Analogue Scale（VAS）
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao Zeng, Doctor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab Injection, Sintilimab injection and Lenvatinib in people with Renal Cell Carcinoma (Kidney Cancer) and Immunotherapy, run by West China 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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 20 Jul 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 Hao Zeng, Doctor (+86-18980602129, kucaizeng@163.com), 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: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.