NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC
ConditionUpper Tract Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Toripalimab
DrugToripalimab is administered intravenously at a dose of 240 mg every 3 weeks for 3 cycles as neoadjuvant therapy prior to surgery.
9MW2821
Drug9MW2821 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/SurgeryParticipants undergo radical nephroureterectomy with or without lymph node dissection according to institutional standard of care.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant Toripalimab + 9MW2821Experimental treatment 2 interventions
Group B: Upfront Surgery (SOC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At the time of surgery (radical nephroureterectomy with or without lymph node dissection).Secondary outcomes
1
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.
Time frame
At the time of surgery or last preoperative imaging assessment.2
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.
Time frame
From randomization up to 1 year.3
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.
Time frame
At the time of surgery (radical nephroureterectomy with or without lymph node dissection).4
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.
Time frame
From the date of surgery through study completion (up to 3 years).Other outcomes
1
Patient-Reported Outcomes (PROs)
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.
Time frame
From baseline through up to 36 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University Third Hospital
Lead sponsor
Jiangsu Provincial People's Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Beijing Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Source ClinicalTrials.gov
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