NMIBCPhase 2NCT06630871
A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
A Phase 2 study testing Distitamab Vedotin in combination with Tislelizumab in people with NMIBC, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- NMIBC
- What is being tested?
- Distitamab Vedotin in combination with Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to Oct 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the experiment and sign a written informed consent form；
- Patients should be aged between 18 and 85 years, with no gender restrictions, no severe organ failure such as heart, lung, or brain, and an expected survival period of one year or more;
- Complete the relevant screening tests (routine blood test, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system ultrasound, pelvic enhanced CT or MRI, and tissue pathology examination), and have no contraindications for TURBt surgery;
- Eastern Cooperative Oncology Group (ECOG) score: 0-2 points;
- Previous systemic therapy without systemic immunity/ADC drugs；
- Histologically confirmed non muscle invasive bladder cancer (NMIBC), with or without carcinoma in situ (CIS), the main pathological type is urothelial carcinoma, including other specific histopathological types, but urothelial carcinoma dominates (at least 50%). Patients with AUA classification of high-risk and extremely high-risk recurrence or progression risk by the American Urological Association, and with immunohistochemical results of Her2 being 3+or 2+, who have undergone maximal TURBt within 6 weeks.
Who cannot join
- Any of the following circumstances: those with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, and who may cause systemic BCG disease reaction; Individuals who are allergic to the components of BCG vaccine; Patients with fever and acute infectious diseases, including active tuberculosis, or those receiving anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease;
- Patients with other urogenital system tumors or other organ tumors;
- Patients with AUA grading of low-risk, moderate risk NMIBC, or myometrial invasive bladder urothelial carcinoma (T2 stage or above), or immunohistochemistry Her2 negative or 1+patients;
- Individuals who have received chemotherapy, radiation therapy, or immunotherapy within the past 4 weeks;
- Pregnant or lactating women, women of childbearing age who have not taken effective contraceptive measures, and those planning to conceive during the trial period (including male subject partners);
- Patients with severe urethral stricture who cannot undergo cystoscopy, those with a history of bladder contracture or functional bladder volume less than 100mL;
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- Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate surgical treatment;
- Participated in clinical trials of other drugs within the past 3 months prior to enrollment;
- Known opioid or alcohol dependent individuals;
- Researchers believe that there may be any situation that increases the risk to participants or interferes with the execution of clinical trials.
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
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jianhui Chen, MMed, 8613055726039, chenjianhui1983@qq.com
About this study
Official title: A Prospective, Multicenter, Single-Arm, Phase Ⅱ, Exploratory Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.
Read the detailed description
The specific implementation process of trial:
Patients diagnosed with high-risk and very high-risk NMIBC, based on medical history, clinical presentation, imaging examinations (such as MRI with plain and enhanced scanning), and transurethral resection for tissue pathological biopsy, are included in the "case screening process";. After excluding surgical contraindications, TURBt is performed; postoperative tissue pathological examination confirms NMIBC, and patients with immunohistochemical results of HER2 as 3+ or 2+ enter further screening. Referring to the AUA guidelines, high-risk and very high-risk NMIBC are included in subsequent analysis, where those who meet the inclusion criteria of this study, excluding the exclusion criteria, and who have recovered well after the initial TURBt and are assessed to be able to complete a second TURBt within six weeks are considered as the final candidates for enrollment.
Eligible patients for single-arm enrollment (N=40) will receive Tislelizumab (200mg) + Disitamab Vedotin (120mg for weight ≤60Kg or 2.0mg/Kg for weight ≥60Kg) the day after the initial TURBt, to be repeated every 3 weeks (Q3W). Patients are also scheduled to undergo a second TURBt within 6 weeks, and after the surgery, they will continue with three more courses of Tislelizumab + Disitamab Vedotin (Q3W) until the end of the 3-year follow-up period. The primary endpoint for evaluation in this study phase is the 1-year event-free survival (EFS), with secondary endpoints including 3-year EFS, 2-year bladder intact disease-free survival (BIDFS), time to total cystectomy, overall survival (OS), quality of life (QLQ-C30), and adverse events.
- Conditions
- NMIBC
- Being tested
- Distitamab Vedotin in combination with Tislelizumab
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distitamab Vedotin in combination with TislelizumabDrug
Also called surgery：re-TURBT
On the day after the initial TURBt procedure, use trastuzumab (200mg)+ Distitamab Vedotin (120mg [≤ 60Kg] or 2.0mg/Kg [>60Kg]) every 3 weeks (Q3W). Simultaneously arrange for the patient to complete a second TURBt within 6 weeks, and continue to use 3 courses of Trastuzumab+Vediximab (Q3W) after surgery until the endpoint of 3-year follow-up
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | High risk and extremely high risk NMIBC for HER2 2 2+or 3+treated with combination therapy of trastuzumab, Distitamab Vedotin, and re-TURBt Receives: Drug: Distitamab Vedotin in combination with Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Event-Free Survival rate
The possibility of patients have not experienced any events for at least 12 months after receiving treatment, including death, disease progression, switch to chemotherapy, addition of other treatments, fatal or intolerable side effects, etc
Measured: From date of randomization until the date of any event occurrence, whichever came first，assessed up to 12 months
Secondary outcomes (7)
3-years Event-Free Survival rate
The possibility of patients have not experienced any events for at least 36 months after receiving treatment, including death, disease progression, switch to chemotherapy, addition of other treatments, fatal or intolerable side effects, etc
Measured: From date of randomization until the date of any event occurrence, whichever came first，assessed up to 36 months
2-year bladder disease-free survival（2 year BIDFS） rate
The probability of patients remaining free from muscle-invasive recurrence, regional lymph node recurrence, distant metastasis, the need for radical cystectomy, or death for at least 24 months after the initiation of treatment
Measured: From date of randomization until the date of muscle-invasive recurrence, regional lymph node recurrence, distant metastasis, the need for radical cystectomy, or death, whichever came first，assessed up to 24 months
Reccurence Free Survival（ RFS）
Time from the first TURBT to the first occurrence of bladder tumor recurrence was recorded by cystoscopy and pathological examination, with the main time points being 1 year, 2 years, and 3 years
Measured: From date of the first TURBT until the date of bladder tumor recurrence, assessed up to 36 months
Overall survival
Time from the start of treatment to death from any causes
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Time to complete bladder resection
Time from the start of treatment to Radical cystectomy
Measured: From date of randomization until the date of radical cystectomy, assessed up to 60 months
Quality of life assessed by QLQ-C30 scale
Assessed by QLQ-C30 scale, higher scores mean better outcomes
Measured: through study completion, an average of 3 years
Adverse events
The type, incidence, relatedness, and severity of adverse events
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene, RemeGen Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630871
- Sponsor's protocol ID
- 2024YF042-01
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Phase Ⅱ, Exploratory Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
- ClinicalTrials.gov ID
- NCT06630871
- Acronym / sponsor ID
- 2024YF042-01
- Conditions
- NMIBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- BeiGene, RemeGen Co., Ltd.
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Oct 2024 (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 prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.
Detailed description
The specific implementation process of trial:
Patients diagnosed with high-risk and very high-risk NMIBC, based on medical history, clinical presentation, imaging examinations (such as MRI with plain and enhanced scanning), and transurethral resection for tissue pathological biopsy, are included in the "case screening process";. After excluding surgical contraindications, TURBt is performed; postoperative tissue pathological examination confirms NMIBC, and patients with immunohistochemical results of HER2 as 3+ or 2+ enter further screening. Referring to the AUA guidelines, high-risk and very high-risk NMIBC are included in subsequent analysis, where those who meet the inclusion criteria of this study, excluding the exclusion criteria, and who have recovered well after the initial TURBt and are assessed to be able to complete a second TURBt within six weeks are considered as the final candidates for enrollment.
Eligible patients for single-arm enrollment (N=40) will receive Tislelizumab (200mg) + Disitamab Vedotin (120mg for weight ≤60Kg or 2.0mg/Kg for weight ≥60Kg) the day after the initial TURBt, to be repeated every 3 weeks (Q3W). Patients are also scheduled to undergo a second TURBt within 6 weeks, and after the surgery, they will continue with three more courses of Tislelizumab + Disitamab Vedotin (Q3W) until the end of the 3-year follow-up period. The primary endpoint for evaluation in this study phase is the 1-year event-free survival (EFS), with secondary endpoints including 3-year EFS, 2-year bladder intact disease-free survival (BIDFS), time to total cystectomy, overall survival (OS), quality of life (QLQ-C30), and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Distitamab Vedotin in combination with TislelizumabHigh risk and extremely high risk NMIBC for HER2 2 2+or 3+treated with combination therapy of trastuzumab, Distitamab Vedotin, and re-TURBt |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate in the experiment and sign a written informed consent form；
- Patients should be aged between 18 and 85 years, with no gender restrictions, no severe organ failure such as heart, lung, or brain, and an expected survival period of one year or more;
- Complete the relevant screening tests (routine blood test, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system ultrasound, pelvic enhanced CT or MRI, and tissue pathology examination), and have no contraindications for TURBt surgery;
- Eastern Cooperative Oncology Group (ECOG) score: 0-2 points;
- Previous systemic therapy without systemic immunity/ADC drugs；
Key exclusion criteria (10 listed)
- Any of the following circumstances: those with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, and who may cause systemic BCG disease reaction; Individuals who are allergic to the components of BCG vaccine; Patients with fever and acute infectious diseases, including active tuberculosis, or those receiving anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease;
- Patients with other urogenital system tumors or other organ tumors;
- Patients with AUA grading of low-risk, moderate risk NMIBC, or myometrial invasive bladder urothelial carcinoma (T2 stage or above), or immunohistochemistry Her2 negative or 1+patients;
- Individuals who have received chemotherapy, radiation therapy, or immunotherapy within the past 4 weeks;
- Pregnant or lactating women, women of childbearing age who have not taken effective contraceptive measures, and those planning to conceive during the trial period (including male subject partners);
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 |
|---|---|---|
| Distitamab Vedotin in combination with TislelizumabAlso: surgery：re-TURBTOn the day after the initial TURBt procedure, use trastuzumab (200mg)+ Distitamab Vedotin (120mg [≤ 60Kg] or 2.0mg/Kg [>60Kg]) every 3 weeks (Q3W). Simultaneously arrange for the patient to complete a second TURBt within 6 weeks, and continue to use 3 courses of Trastuzumab+Vediximab (Q3W) after surgery until the endpoint of 3-year follow-up | Drug | Experimental group |
Primary outcome
1-year Event-Free Survival rate
Time frame: From date of randomization until the date of any event occurrence, whichever came first，assessed up to 12 months
The possibility of patients have not experienced any events for at least 12 months after receiving treatment, including death, disease progression, switch to chemotherapy, addition of other treatments, fatal or intolerable side effects, etc
7 secondary outcomes
3-years Event-Free Survival rate
Time frame: From date of randomization until the date of any event occurrence, whichever came first，assessed up to 36 months
2-year bladder disease-free survival（2 year BIDFS） rate
Time frame: From date of randomization until the date of muscle-invasive recurrence, regional lymph node recurrence, distant metastasis, the need for radical cystectomy, or death, whichever came first，assessed up to 24 months
Reccurence Free Survival（ RFS）
Time frame: From date of the first TURBT until the date of bladder tumor recurrence, assessed up to 36 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Time to complete bladder resection
Time frame: From date of randomization until the date of radical cystectomy, assessed up to 60 months
Quality of life assessed by QLQ-C30 scale
Time frame: through study completion, an average of 3 years
Adverse events
Time frame: through study completion, an average of 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 10 Oct 2024.
- Individual participant dataSharing planned: No
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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 Distitamab Vedotin in combination with Tislelizumab in people with NMIBC, run by Fujian Medical University Union 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 6 inclusion and 10 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 10 Oct 2024. 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 Jianhui Chen (86-13055726039, chenjianhui1983@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Event-Free Survival rate (time frame: From date of randomization until the date of any event occurrence, whichever came first，assessed up to 12 months). 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 10 Oct 2024.