Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07412171

NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Upper Tract Urothelial Carcinoma Disease Attributes Disease Progression Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Toripalimab

Drug

Toripalimab is administered intravenously at a dose of 240 mg every 3 weeks for 3 cycles as neoadjuvant therapy prior to surgery.

9MW2821

Drug

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 Dissection

Procedure

Participants undergo radical nephroureterectomy with or without lymph node dissection according to institutional standard of care.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: At the time of surgery or last preoperative imaging assessment.

    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.

  2. 1-year Event-Free Survival (EFS)

    Time frame: From randomization up to 1 year.

    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.

  3. Percentage of Participants With Pathologic Downstaging (pDS)

    Time frame: At the time of surgery (radical nephroureterectomy with or without lymph node dissection).

    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.

  4. Disease-Free Survival (DFS)

    Time frame: From the date of surgery through study completion (up to 3 years).

    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.

  5. Overall Survival (OS)

    Time frame: From randomization through study completion (up to 3 years).

    Overall survival (OS) is defined as the time from randomization to death from any cause.

  6. Incidence of Adverse Events

    Time frame: From first dose of study treatment through 90 days after treatment.

    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.

  7. Perioperative Complications

    Time frame: From the start of surgery through 90 days after surgery.

    Perioperative complications are defined as intraoperative and postoperative complications directly attributable to the surgical procedure or perioperative management.

Other outcomes

  1. Patient-Reported Outcomes (PROs)

    Time frame: From baseline through up to 36 months.

    Patient-reported outcomes (PROs) are assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a validated, cancer-specific questionnaire that includes a Global Health Status/Quality of Life scale and multiple functional and symptom scales, including Physical Functioning.

    All EORTC QLQ-C30 scale scores range from 0 to 100. For the Global Health Status/Quality of Life and functional scales, higher scores indicate better quality of life or functioning. For symptom scales, higher scores indicate greater symptom burden. Changes from baseline in PRO scores are summarized to describe symptom burden, functional status, and health-related quality of life over time.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beijing Friendship Hospital
  • Jiangsu Provincial People's Hospital
  • Peking University Cancer Hospital & Institute
  • The First Affiliated Hospital of Zhengzhou University
  • The Second Affiliated Hospital of Kunming Medical University

Registry information

Official study 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)

Acronym: NECTAR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.