CClinicalTrials.gg
RecruitingNCT05495724Updated Aug 10, 2022

Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

A Phase 2 interventional study of Disitamab Vedotin Tislelizumab and Disitamab Vedotin in Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Tianjin Medical University Second Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Tianjin Medical University Second Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Registered 1 year after the study started (first participant enrolled Jul 2021, registered Aug 2022).
  • Started Jul 2021; still recruiting 5 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.

02

Conditions studied

  • Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

Keywords

  • Disitamab Vedotin
  • Tislelizumab
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 176 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years;
  2. Urothelial carcinoma with Her2 IHC 2+ or 3+;
  3. High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:

    a. T1 b. High-grade Ta c.Carcinoma in situ(CIS);

  4. Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;
  5. Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
  6. Organ function level must meet or under the support treatment meet the following requirements:

    • Hematological indexes: neutrophil count >= 1.5x10\^9/L, platelet count >= 100x10\^9/L, hemoglobin >= 9.0 g/dl;
    • Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN(patient with metastatic liver cancer:aminotransferase \<=5.0 ULN);
    • Renal function: creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 50 ml/min;
  7. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;

Exclusion criteria

Exclusion Criteria:

  1. Active, known or suspected autoimmune diseases;
  2. History of primary immunodeficiency;
  3. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  4. Pregnant or lactating female patients;
  5. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
  6. Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose);
  7. Known or suspected allergy to disitamab vedotin or tislelizumab;
  8. Have a clear history of active tuberculosis;
  9. Participating in other clinical researchers;
  10. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
  11. Uncontrolled concurrent diseases, including but not limited to:

    • HIV infected (HIV antibody positive);
    • Severe infection in active stage or poorly controlled;
    • Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]);
    • Patients with active bleeding or new thrombotic disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
176 participants (estimated)

Study arms

  • Experimental
    Disitamab Vedotin and Tislelizumab

    Disitamab Vedotin 120mg IV on day 1 in combination with Tislelizumab 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.

    Drug: Disitamab Vedotin Tislelizumab

  • Other
    Disitamab Vedotin

    Disitamab Vedotin 120mg IV on day 1 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.

    Drug: Disitamab Vedotin

Interventions

  • DrugDisitamab Vedotin Tislelizumab

    Disitamab Vedotin 120mg will be administered on Day 1 of each cycle for 4 treatment cycles;Tislelizumab 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.

    Also known as: KEYNOTE-057

  • DrugDisitamab Vedotin

    Disitamab Vedotin

06

What researchers measure

Primary outcomes

  1. Complete Response (CR) Rate

    Time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of disitamab vedotin)

Secondary outcomes

  1. Progress Free Survival(PFS)

    Time frame: up to 3 years

  2. Recurrence Free Survival(RFS)

    Time frame: up to 3 years

  3. Cystectomy-Free Survival (CFS)

    defined from D1 of treatment until cystectomy

    Time frame: up to 3 years

  4. Duration of Response (DOR)

    Time frame: up to 3 years

  5. Event-Free Survival(EFS)

    defined from D1 of treatment until the time of any events,included progressive disease,discontinue treatment for any cause or death

    Time frame: up to 3 years

  6. Number of adverse events and severity by grade (CTCAE)

    Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).

    Time frame: 12 weeks of treatment plus 30 days for toxicity followup

  7. Her2 status

    Time frame: up to 3 years

  8. PD-1 expression status

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Second Hospital
    Tianjin, Tianjin 300211, China
    • Hailong Hu · Contact · hhllove2004@163.com · +86-13662096232
    • Hailong Hu, MD,PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05495724
Lead sponsor
Tianjin Medical University Second Hospital
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Jul 23, 2021
Primary completion
Feb 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Aug 10, 2022

Study contacts

Hailong Hu
Contact
hhllove2004@163.com
+86-13662096232
Hailong Hu
principal investigator · Tianjin Medical University Second Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion