Renal Cell Carcinoma (RCC)Phase 2PLUTONCT06114940
Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PLUTO)
A Phase 2 study testing Toripalimab and Lenvatinib in people with Renal Cell Carcinoma (RCC), run by Jinling Hospital, China at 1 site in China.
Trial summary
The PLUTO-trial is a single-center, open-label, phase II trial investigating Toripalimab plus Lenvatinib in patients with multi-stage clear-cell renal cell carcinoma. In this trial, patients will be enrolled in one of three cohorts according to the stage of their clear-cell renal-cell carcinoma: localized, locally… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Toripalimab 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
- 17 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 10 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Have fully understood and voluntarily signed the informed consent Form (ICF);
- Age: 18-80 years old (at the time of signing the informed consent); Both male and female; ECOG PS score: 0-1;
- RCC with clear cell component confirmed by histology or cytopathology, including locally advanced RCC with clear cell component;
- ECOG 0-1 points
- T1b-T2bN0M0, T3a-4N0M0, TanyN1M0 or M1RCC diagnosed by imaging at initial diagnosis:
- Cohort 1: T1b-T2bN0M0 RCC;
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- Cohort 2: T3a-4N0M0 or TanyN1M0 RCC;
- Cohort 3: M1 RCC undergoing cytoreductive nephrectomy.
- Radical nephrectomy or partial nephrectomy or renal tumor enucleation was decided after the clinician made the treatment plan and communicated with the patient;
- Willingness and ability to comply with planned visits, therapeutic laboratory testing, and other procedures.
Who cannot join
- Signs of tumor metastasis involving the central nervous system;
- History of malignant tumors other than the study disease within the previous 5 years, with the exception of malignant tumors that can be expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery);
- Prior to participating in the study, patients had received other systemic treatment drugs, including targeted drugs, immunotherapy drugs and their combination regimens, or local anti-tumor therapy, or received investigational drugs or device therapy;
- Underwent major surgery (judged by the investigator) within 4 weeks before the first trial dose, were recovering, or were unable to undergo baseline puncture;
- History of severe drug allergy, including but not limited to antibody drugs;
- patients with contraindications to immunotherapy restart, including but not limited to:
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- Grade 2-4 immune myocarditis;
- Severe grade 4 proteinuria;
- Severe or life-threatening grade 4 immune hepatitis;
- Severe grade 3-4 immune pneumonitis;
- Severe inflammatory arthritis that significantly affects daily life or quality of life;
- Severe neurological toxicity:
- Myasthenia gravis grade 2-4;
- Guillain-Barre syndrome (GBS) or transverse myelitis of any grade;
- Grade 2-4 encephalitis;
- Severe or life-threatening grade 3-4 pancreatitis;
- Severe or life-threatening bullous disease (grade 3-4);
- Severe grade 3-4 uveitis or episcleritis;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or long-term corticosteroid therapy. Patients with thyroid, suprarenal or hypopituitarism that could be controlled only with hormone replacement therapy, type 1 diabetes mellitus, psoriasis or vitiligo without systemic treatment, etc., were eligible to participate in the study.
- Non-resolution of toxicity after previous antineoplastic therapy, i.e., resolution to baseline, NCI-CTCAE 5.0 grade 0-1 (excluding alopecia), or inclusion/exclusion criteria. Irreversible toxicities (e.g., hearing loss) that would not reasonably be expected to be exacerbated by the study drug can be included in the study;
- Known history of clinically significant liver disease, including active viral hepatitis (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HbcAb) positive, HBV DNA>10000 copies /mL or >2000 IU/mL; Hepatitis C virus (HCV) antibody positive and HCV RNA positive], or other active hepatitis, clinically significant moderate to severe cirrhosis;
- Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients who do not need drainage of effusion or stop drainage for 3 days without significant increase in effusion can be enrolled);
- Receiving a systemic corticosteroid (prednisone > 10mg/ day or equivalent) or other immunosuppressive medication within 14 days before the first study medication;
- Patients with any severe and/or uncontrolled disease, including:
- Hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg);
- Unstable angina pectoris or myocardial infarction, coronary artery bypass grafting or stent implantation within 6 months before study medication;
- Grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc≥480ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); Degree Ⅱ or above heart block; Left ventricular ejection fraction (LVEF) < 50%;
- Poorly controlled diabetes (fasting blood glucose > 10 mmol/L);
- Patients with urinary protein ≥++ and confirmed 24-hour urinary protein > 1.0g;
- Severe active or uncontrolled infection;
- Patients with or suspected to have active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.;
- Renal failure requiring hemodialysis or peritoneal dialysis;
- Patients with a history of immunodeficiency, including HIV positive patients, other acquired immunodeficiency diseases, congenital immunodeficiency diseases, or organ transplantation history;
- History of live attenuated vaccine inoculation within 4 weeks before the first study drug or the expected vaccination during the study period;
- History of psychiatric drug abuse and can not quit or have a history of mental disorders;
- The presence of any other severe, acute or chronic medical disease or mental illness or laboratory abnormality, as judged by the investigator, that may increase the risk associated with participation in the study or that may interfere with the interpretation of the results of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, 210000
About this study
Official title: PLUTO: A Prospective Phase II Study of Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
The PLUTO-trial is a single-center, open-label, phase II trial investigating Toripalimab plus Lenvatinib in patients with multi-stage clear-cell renal cell carcinoma. In this trial, patients will be enrolled in one of three cohorts according to the stage of their clear-cell renal-cell carcinoma: localized, locally advanced and metastatic RCC. Patients in all cohorts will receive four to five cycles of preoperative Toripalimab (240mg Q3W IV) plus Lenvatinib (20mg QD PO) and will undergo nephrectomy within four weeks after the last cycle. Patients in cohort 1 who are considered to be at high risk according to pathology results of surgery specimen, and all the patients in cohort 2 are supposed to receive postoperative doses of Toripalimab (240mg Q3W IV) for at most 17 doses. Patients in cohort 3 are supposed to continue Toripalimab plus Lenvatinib after surgery.
The primary clinical endpoint of the study is immune-related pathological response to tumorigenesis, defined as the extent of tumor cell reduction in the tumor bed. Simon's two-stage design is used in this study. An initial cohort of 12 patients per cohort will be recruited, followed by an interim analysis. Recruitment to each cohort will be closed if a qualifying immune-related pathological response is not observed in any patient at an interim analysis. If qualifying immune-related pathological response is observed in at least one patient, additional 9 patients will be recruited in the cohort to 21 patients. Considering potential 10% dropout rate in the trial, an anticipation of 69 patients will be recruited for this study.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Toripalimab, Lenvatinib
- Keywords
- ccRCC, Perioperative therapy, Immunotherapy, Tyrosine Kinase Inhibitors, nephrectomy
- 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.
ToripalimabDrug
Also called anti-PD-1 monoclonal antibody
Preoperative: Toripalimab 240mg, IV on day 1 in a 3-week cycle. Preoperative Toripalimab contains 4-5 cycles.
Postoperative: Toripalimab 240mg, IV on day 1 of a 3-week cycle. Postoperative Toripalimab following surgery within 4 weeks for patients mentioned above in cohort 1, 2 and 3.
LenvatinibDrug
Also called Lenvatinib mesylate (USAN), E7080, ER-203492-00, Multi-Kinase Inhibitor E7080
Preoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Preoperative Lenvatinib contains 4-5 cycles.
Postoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Postoperative Lenvatinib following surgery within 4 weeks for patients in cohort 3.
Adjustment of dose: For patients with intolerable adverse reactions (CTCAE v5.0 grade 3 or grater), the dose could be reduced to 12mg for those who were suitable to continue taking the drug after systematic evaluation by the investigator. Patients who are assessed as intolerable and not suitable for continued medication will discontinue and undergo nephrectomy within 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab + Lenvatinib followed by nephrectomy | Experimental | After 4-5 cycles of preoperative therapy, patients will undergo nephrectomy within 4 weeks. Patients with WHO/ISUP grading 4 RCC in cohort 1, and all patients of cohort 2 and 3 will receive postoperative dosing within 4 weeks for at most 17 doses. Subsequent follow-up will then be completed to assess adverse events and long-term outcomes.
Cohort 1: Localized RCC (cT1b-T2bN0M0). Nephrectomy following preoperative therapy. For patients with WHO/ISUP grading 4 RCC in the resected tumor, postoperative dosing of Toripalimab beginning within 4 weeks after surgery for at most 17 doses.
Cohort 2: Locally advanced RCC (cT3-4N0M0 or cTanyN1M0). Nephrectomy following preoperative therapy. Postoperative dosing of Toripalimab beginning within 4 weeks after surgery for at most 17 doses.
Cohort 3: Metastatic RCC (cTanyNanyM1). Cytoreductive nephrectomy following preoperative therapy. Postoperative dosing of Toripalimab plus Lenvatinib beginning within 4 weeks after surgery for at most 17 doses. Receives: Drug: Toripalimab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-related pathologic reponse rate (irPR）
IrPR is defined as the proportion of patients achieving a complete pathologic or major pathologic response. Complete or major pathological response are assessed according to the proportion of viable residual tumor in the initial tumor bed of HE sections from tumor tissue. Complete pathological response means no viable residue tumor in the initial tumor bed, and major pathological response with a ≤10% viable residue tumor in the initial tumor bed.
Measured: Date of surgery
Secondary outcomes (7)
Adverse events
The number of participants experiencing adverse events according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0). The safety profile of the treatment will be documented and summarized by summary statistics as frequency and percentage for each AE.
Measured: From first dose to 28 days after last dose
Surgical morbidity
Surgical morbidity is assessed by Clavien-Dindo classification.
Measured: From date of surgery up to 28 days after surgery
Objective response rate (ORR)
Tumor response rate is assessed respectively according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). ORR is defined as the proportion of patients who are evaluated as CR and PR.
Measured: Baseline to date of surgery
Imaging density changes of lesions
Patients will undergo baseline and preoperative contrast-enhanced CT scans. In the portal venous phase, the margins of the primary and metastatic lesions will be outlined, and their average CT values will be calculated to reflect the change in density at a time.
Measured: Baseline to date of surgery
Down-staging rate of primary tumor T staging
The T stage of the primary tumor will be evaluated according to the AJCC criteria at baseline and before surgery to reflect the change in T stage of the primary tumor after preoperative treatment.
Measured: Baseline to date of surgery
Rate of distant metastasis
At postoperative follow-up, the number and timing of patients who developed distant metastases will be recorded. This endpoint focuses on patients in cohort 1 and 2.
Measured: Up to 2 years after surgery. Patients will be followed every 3 months the 1st year, and every 6 months the next year.
Progression free survival (PFS)
PFS is defined as the time from the first dose of neoadjuvant theratpy to progression disease or death from any cause, whichever occurs first.
Measured: Up to 2 years after surgery. Patients will be followed every 3 months the 1st year, and every 6 months the next year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start20 Dec 2022
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Why it stopped: Involving changes to the primary endpoint, it is difficult to unify the evaluation criteria for subjects' endpoints before and after the change.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114940
- Sponsor's protocol ID
- 2025DZKY-005-02
- Acronym
- PLUTO
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLUTO: A Prospective Phase II Study of Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
- ClinicalTrials.gov ID
- NCT06114940
- Acronym / sponsor ID
- PLUTO / 2025DZKY-005-02
- Conditions
- Renal Cell Carcinoma (RCC)
- Keywords
- ccRCC, Perioperative therapy, Immunotherapy, Tyrosine Kinase Inhibitors, nephrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Involving changes to the primary endpoint, it is difficult to unify the evaluation criteria for subjects' endpoints before and after the change.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 2 Nov 2023 (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.
The PLUTO-trial is a single-center, open-label, phase II trial investigating Toripalimab plus Lenvatinib in patients with multi-stage clear-cell renal cell carcinoma. In this trial, patients will be enrolled in one of three cohorts according to the stage of their clear-cell renal-cell carcinoma: localized, locally advanced and metastatic RCC. Patients in all cohorts will receive four to five cycles of preoperative Toripalimab (240mg Q3W IV) plus Lenvatinib (20mg QD PO) and will undergo nephrectomy within four weeks after the last cycle. Patients in cohort 1 who are considered to be at high risk according to pathology results of surgery specimen, and all the patients in cohort 2 are supposed to receive postoperative doses of Toripalimab (240mg Q3W IV) for at most 17 doses. Patients in cohort 3 are supposed to continue Toripalimab plus Lenvatinib after surgery.
The primary clinical endpoint of the study is immune-related pathological response to tumorigenesis, defined as the extent of tumor cell reduction in the tumor bed. Simon's two-stage design is used in this study. An initial cohort of 12 patients per cohort will be recruited, followed by an interim analysis. Recruitment to each cohort will be closed if a qualifying immune-related pathological response is not observed in any patient at an interim analysis. If qualifying immune-related pathological response is observed in at least one patient, additional 9 patients will be recruited in the cohort to 21 patients. Considering potential 10% dropout rate in the trial, an anticipation of 69 patients will be recruited for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab + Lenvatinib followed by nephrectomy | Experimental | Drug: Toripalimab, Drug: LenvatinibAfter 4-5 cycles of preoperative therapy, patients will undergo nephrectomy within 4 weeks. Patients with WHO/ISUP grading 4 RCC in cohort 1, and all patients of cohort 2 and 3 will receive postoperative dosing within 4 weeks for at most 17 doses. Subsequent follow-up will then be completed to assess adverse events and long-term outcomes. Cohort 1: Localized RCC (cT1b-T2bN0M0). Nephrectomy following preoperative therapy. For patients with WHO/ISUP grading 4 RCC in the resected tumor, postoperative dosing of Toripalimab beginning within 4 weeks after surgery for at most 17 doses. Cohort 2: Locally advanced RCC (cT3-4N0M0 or cTanyN1M0). Nephrectomy following preoperative therapy. Postoperative dosing of Toripalimab beginning within 4 weeks after surgery for at most 17 doses. Cohort 3: Metastatic RCC (cTanyNanyM1). Cytoreductive nephrectomy following preoperative therapy. Postoperative dosing of Toripalimab plus Lenvatinib beginning within 4 weeks after surgery for at most 17 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have fully understood and voluntarily signed the informed consent Form (ICF);
- Age: 18-80 years old (at the time of signing the informed consent); Both male and female; ECOG PS score: 0-1;
- RCC with clear cell component confirmed by histology or cytopathology, including locally advanced RCC with clear cell component;
- ECOG 0-1 points
- T1b-T2bN0M0, T3a-4N0M0, TanyN1M0 or M1RCC diagnosed by imaging at initial diagnosis:
Key exclusion criteria (36 listed)
- Signs of tumor metastasis involving the central nervous system;
- History of malignant tumors other than the study disease within the previous 5 years, with the exception of malignant tumors that can be expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery);
- Prior to participating in the study, patients had received other systemic treatment drugs, including targeted drugs, immunotherapy drugs and their combination regimens, or local anti-tumor therapy, or received investigational drugs or device therapy;
- Underwent major surgery (judged by the investigator) within 4 weeks before the first trial dose, were recovering, or were unable to undergo baseline puncture;
- History of severe drug allergy, including but not limited to antibody drugs;
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 |
|---|---|---|
| ToripalimabAlso: anti-PD-1 monoclonal antibodyPreoperative: Toripalimab 240mg, IV on day 1 in a 3-week cycle. Preoperative Toripalimab contains 4-5 cycles. Postoperative: Toripalimab 240mg, IV on day 1 of a 3-week cycle. Postoperative Toripalimab following surgery within 4 weeks for patients mentioned above in cohort 1, 2 and 3. | Drug | Toripalimab + Lenvatinib followed by nephrectomy |
| LenvatinibAlso: Lenvatinib mesylate (USAN), E7080, ER-203492-00, Multi-Kinase Inhibitor E7080Preoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Preoperative Lenvatinib contains 4-5 cycles. Postoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Postoperative Lenvatinib following surgery within 4 weeks for patients in cohort 3. Adjustment of dose: For patients with intolerable adverse reactions (CTCAE v5.0 grade 3 or grater), the dose could be reduced to 12mg for those who were suitable to continue taking the drug after systematic evaluation by the investigator. Patients who are assessed as intolerable and not suitable for continued medication will discontinue and undergo nephrectomy within 4 weeks. | Drug | Toripalimab + Lenvatinib followed by nephrectomy |
Primary outcome
Immune-related pathologic reponse rate (irPR）
Time frame: Date of surgery
IrPR is defined as the proportion of patients achieving a complete pathologic or major pathologic response. Complete or major pathological response are assessed according to the proportion of viable residual tumor in the initial tumor bed of HE sections from tumor tissue. Complete pathological response means no viable residue tumor in the initial tumor bed, and major pathological response with a ≤10% viable residue tumor in the initial tumor bed.
7 secondary outcomes
Adverse events
Time frame: From first dose to 28 days after last dose
Surgical morbidity
Time frame: From date of surgery up to 28 days after surgery
Objective response rate (ORR)
Time frame: Baseline to date of surgery
Imaging density changes of lesions
Time frame: Baseline to date of surgery
Down-staging rate of primary tumor T staging
Time frame: Baseline to date of surgery
Rate of distant metastasis
Time frame: Up to 2 years after surgery. Patients will be followed every 3 months the 1st year, and every 6 months the next year.
Progression free survival (PFS)
Time frame: Up to 2 years after surgery. Patients will be followed every 3 months the 1st year, and every 6 months the next year.
Results and safety
The study was stopped early (reason given: Involving changes to the primary endpoint, it is difficult to unify the evaluation criteria for subjects' endpoints before and after the change.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Toripalimab and Lenvatinib in people with Renal Cell Carcinoma (RCC), run by Jinling Hospital, China 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 36 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: stopped early, as of the sponsor's last update on 5 Mar 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?
The study was stopped early (reason given: Involving changes to the primary endpoint, it is difficult to unify the evaluation criteria for subjects' endpoints before and after the change.). Results are not available in the source record.
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?
Immune-related pathologic reponse rate (irPR） (time frame: Date of surgery). 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 5 Mar 2026.