Upper Tract Urothelial CarcinomaPhase 2NECTARNCT07412171
NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC
A Phase 2 study testing Toripalimab, 9MW2821 and Radical Nephroureterectomy with or without Lymph Node Dissection in people with Upper Tract Urothelial Carcinoma, run by Peking University Third Hospital at 1 site in China.
Trial summary
The NECTAR study is a multicenter, open-label, randomized phase II clinical trial designed to evaluate a neoadjuvant treatment strategy in patients with localized upper tract urothelial carcinoma (UTUC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Tract Urothelial Carcinoma
- What is being tested?
- Toripalimab, 9MW2821 and Radical Nephroureterectomy with or without Lymph Node Dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Dec 2028
- 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
- Adults aged 18 to 80 years, male or female.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) involving the renal pelvis and/or ureter, with predominant (≥50%) urothelial histology.
- Treatment-naïve, non-metastatic disease (M0) with clinical stage T1-T3, as determined by imaging.
- Eligible for and willing to undergo radical nephroureterectomy with or without lymph node dissection.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, renal, and cardiac function as defined by the protocol.
- Availability of tumor tissue for biomarker analyses.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Prior systemic anti-tumor therapy for urothelial carcinoma, except for intravesical therapy for non-muscle-invasive disease.
- Prior treatment with a programmed cell death 1 (PD-1) inhibitor, programmed cell death ligand 1 or 2 (PD-L1/L2) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, or antibody-drug conjugate.
- Evidence of metastatic disease (M1) or regional lymph node involvement of N2 or higher.
- Prior systemic anticancer therapy, including investigational agents, within 3 years prior to study enrollment.
- Prior radiotherapy to the bladder or upper urinary tract.
- Active autoimmune disease requiring systemic treatment.
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- Active or uncontrolled infection, including known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) infection, or active tuberculosis.
- Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment.
- History of allogeneic tissue or solid organ transplantation.
- Uncontrolled diabetes mellitus, defined as hemoglobin A1c ≥8%, or hemoglobin A1c ≥7% to <8% with associated diabetes-related symptoms.
- Clinically significant cardiovascular disease or thromboembolic events that, in the investigator's judgment, would increase study risk.
- Ongoing peripheral sensory or motor neuropathy of Grade 2 or higher.
- Known psychiatric disorder or substance abuse that would interfere with study participation or compliance.
- Pregnancy or breastfeeding.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Clinical Trial Office, +86 10 8226 5573, bysy@bjmu.edu.cn
About this study
Official title: NECTAR Study: A Multicenter, Open-label, Randomized Phase II Study of Neoadjuvant Toripalimab Plus 9MW2821 Versus Upfront Radical Nephroureterectomy With/Without Lymph Node Dissection in Patients With Local Upper Tract Urothelial Carcinoma (UTUC)
The NECTAR study is a multicenter, open-label, randomized phase II clinical trial designed to evaluate a neoadjuvant treatment strategy in patients with localized upper tract urothelial carcinoma (UTUC).
In this study, eligible participants will be randomly assigned to receive either neoadjuvant treatment with toripalimab plus the investigational drug 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection, or upfront radical nephroureterectomy with or without lymph node dissection as standard of care. The purpose of the study is to compare the pathologic response at the time of surgery between the two treatment approaches and to assess treatment safety.
Participants will be monitored throughout treatment and follow-up for treatment response, adverse events, and other clinical outcomes. The information obtained from this study may help improve future treatment strategies for patients with localized UTUC.
- Conditions
- Upper Tract Urothelial Carcinoma
- Being tested
- Toripalimab, 9MW2821, Radical Nephroureterectomy with or without Lymph Node Dissection
- Keywords
- UTUC, Toripalimab, 9MW2821, Neoadjuvant Therapy, Radical Nephroureterectomy, Immunotherapy, Phase II, Pathologic Complete Response
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab is administered intravenously at a dose of 240 mg every 3 weeks for 3 cycles as neoadjuvant therapy prior to surgery.
9MW2821Drug
9MW2821 is administered intravenously at a dose of 1.25 mg/kg on Day 1 and Day 8 every 3 weeks for 3 cycles as neoadjuvant therapy.
Radical Nephroureterectomy with or without Lymph Node DissectionProcedure or surgery
Participants undergo radical nephroureterectomy with or without lymph node dissection according to institutional standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Toripalimab + 9MW2821 | Experimental | Participants receive neoadjuvant toripalimab plus 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection. Receives: Drug: Toripalimab; Drug: 9MW2821 |
| Upfront Surgery (SOC) | Active comparator | Participants undergo upfront radical nephroureterectomy with or without lymph node dissection according to standard of care. Receives: Procedure: Radical Nephroureterectomy with or without Lymph Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Pathologic Complete Response (pCR)
Pathologic complete response (pCR) is defined as the absence of residual viable urothelial carcinoma in the resected primary tumor and sampled lymph nodes (e.g., ypT0N0) based on final surgical pathology following radical nephroureterectomy with or without lymph node dissection.
Measured: At the time of surgery (radical nephroureterectomy with or without lymph node dissection).
Secondary outcomes (7)
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on radiographic assessment according to RECIST version 1.1.
Measured: At the time of surgery or last preoperative imaging assessment.
1-year Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of radiographic disease progression that precludes definitive surgery, failure to undergo surgery in participants with residual disease, gross residual disease at surgery, recurrence after surgery (local or distant), or death from any cause.
Measured: From randomization up to 1 year.
Percentage of Participants With Pathologic Downstaging (pDS)
Pathologic downstaging (pDS) is defined as a reduction in pathologic stage at the time of surgery compared with the baseline clinical stage, based on final surgical pathology.
Measured: At the time of surgery (radical nephroureterectomy with or without lymph node dissection).
Disease-Free Survival (DFS)
Disease-free survival (DFS) is defined as the time from radical nephroureterectomy with or without lymph node dissection to the first documented recurrence (local or distant) or death from any cause, whichever occurs first.
Measured: From the date of surgery through study completion (up to 3 years).
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause.
Measured: From randomization through study completion (up to 3 years).
Incidence of Adverse Events
Safety and tolerability are assessed by the incidence, nature, and severity of adverse events (AEs), including serious adverse events (SAEs) and adverse events leading to dose modification or discontinuation. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From first dose of study treatment through 90 days after treatment.
Perioperative Complications
Perioperative complications are defined as intraoperative and postoperative complications directly attributable to the surgical procedure or perioperative management.
Measured: From the start of surgery through 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412171
- Sponsor's protocol ID
- LM2026029
- Other IDs
- IRB00006761, M20250851
- Acronym
- NECTAR
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not been determined at this time. Decisions regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and sponsor agreements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NECTAR Study: A Multicenter, Open-label, Randomized Phase II Study of Neoadjuvant Toripalimab Plus 9MW2821 Versus Upfront Radical Nephroureterectomy With/Without Lymph Node Dissection in Patients With Local Upper Tract Urothelial Carcinoma (UTUC)
- ClinicalTrials.gov ID
- NCT07412171
- Acronym / sponsor ID
- NECTAR / LM2026029
- Conditions
- Upper Tract Urothelial Carcinoma
- Keywords
- UTUC, Toripalimab, 9MW2821, Neoadjuvant Therapy, Radical Nephroureterectomy, Immunotherapy, Phase II, Pathologic Complete Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Kunming Medical University
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Feb 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.
The NECTAR study is a multicenter, open-label, randomized phase II clinical trial designed to evaluate a neoadjuvant treatment strategy in patients with localized upper tract urothelial carcinoma (UTUC).
In this study, eligible participants will be randomly assigned to receive either neoadjuvant treatment with toripalimab plus the investigational drug 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection, or upfront radical nephroureterectomy with or without lymph node dissection as standard of care. The purpose of the study is to compare the pathologic response at the time of surgery between the two treatment approaches and to assess treatment safety.
Participants will be monitored throughout treatment and follow-up for treatment response, adverse events, and other clinical outcomes. The information obtained from this study may help improve future treatment strategies for patients with localized UTUC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Toripalimab + 9MW2821 | Experimental | Drug: Toripalimab, Drug: 9MW2821Participants receive neoadjuvant toripalimab plus 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection. |
| Upfront Surgery (SOC) | Active comparator | Procedure: Radical Nephroureterectomy with or without Lymph Node DissectionParticipants undergo upfront radical nephroureterectomy with or without lymph node dissection according to standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 80 years, male or female.
- Histologically confirmed upper tract urothelial carcinoma (UTUC) involving the renal pelvis and/or ureter, with predominant (≥50%) urothelial histology.
- Treatment-naïve, non-metastatic disease (M0) with clinical stage T1-T3, as determined by imaging.
- Eligible for and willing to undergo radical nephroureterectomy with or without lymph node dissection.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (15 listed)
- Prior systemic anti-tumor therapy for urothelial carcinoma, except for intravesical therapy for non-muscle-invasive disease.
- Prior treatment with a programmed cell death 1 (PD-1) inhibitor, programmed cell death ligand 1 or 2 (PD-L1/L2) inhibitor, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, or antibody-drug conjugate.
- Evidence of metastatic disease (M1) or regional lymph node involvement of N2 or higher.
- Prior systemic anticancer therapy, including investigational agents, within 3 years prior to study enrollment.
- Prior radiotherapy to the bladder or upper urinary tract.
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 |
|---|---|---|
| ToripalimabToripalimab is administered intravenously at a dose of 240 mg every 3 weeks for 3 cycles as neoadjuvant therapy prior to surgery. | Drug | Neoadjuvant Toripalimab + 9MW2821 |
| 9MW28219MW2821 is administered intravenously at a dose of 1.25 mg/kg on Day 1 and Day 8 every 3 weeks for 3 cycles as neoadjuvant therapy. | Drug | Neoadjuvant Toripalimab + 9MW2821 |
| Radical Nephroureterectomy with or without Lymph Node DissectionParticipants undergo radical nephroureterectomy with or without lymph node dissection according to institutional standard of care. | Procedure or surgery | Upfront Surgery (SOC) |
Primary outcome
Percentage of Participants With Pathologic Complete Response (pCR)
Time frame: At the time of surgery (radical nephroureterectomy with or without lymph node dissection).
Pathologic complete response (pCR) is defined as the absence of residual viable urothelial carcinoma in the resected primary tumor and sampled lymph nodes (e.g., ypT0N0) based on final surgical pathology following radical nephroureterectomy with or without lymph node dissection.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: At the time of surgery or last preoperative imaging assessment.
1-year Event-Free Survival (EFS)
Time frame: From randomization up to 1 year.
Percentage of Participants With Pathologic Downstaging (pDS)
Time frame: At the time of surgery (radical nephroureterectomy with or without lymph node dissection).
Disease-Free Survival (DFS)
Time frame: From the date of surgery through study completion (up to 3 years).
Overall Survival (OS)
Time frame: From randomization through study completion (up to 3 years).
Incidence of Adverse Events
Time frame: From first dose of study treatment through 90 days after treatment.
Perioperative Complications
Time frame: From the start of surgery through 90 days after surgery.
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing has not been determined at this time. Decisions regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and sponsor agreements.
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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.
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, 9MW2821 and Radical Nephroureterectomy with or without Lymph Node Dissection in people with Upper Tract Urothelial Carcinoma, run by Peking University Third 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 8 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: opening soon, as of the sponsor's last update on 17 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Pathologic Complete Response (pCR) (time frame: At the time of surgery (radical nephroureterectomy with or without lymph node dissection).). 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 17 Feb 2026.