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

T

Tianjin Medical University Second Hospital

Status and phase

Enrolling
Phase 2

Conditions

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

Treatments

Drug: Disitamab Vedotin Tislelizumab
Drug: Disitamab Vedotin

Study type

Interventional

Funder types

Other

Identifiers

NCT05495724
TRUCE-04

Details and patient eligibility

About

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.

Enrollment

176 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years;
  • Urothelial carcinoma with Her2 IHC 2+ or 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);

  • 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;
  • Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)

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;
  • The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;

Exclusion criteria

  • Active, known or suspected autoimmune diseases;
  • History of primary immunodeficiency;
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • Pregnant or lactating female patients;
  • 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;
  • 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);
  • Known or suspected allergy to disitamab vedotin or tislelizumab;
  • Have a clear history of active tuberculosis;
  • Participating in other clinical researchers;
  • Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

176 participants in 2 patient groups

Disitamab Vedotin and Tislelizumab
Experimental group
Description:
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.
Treatment:
Drug: Disitamab Vedotin Tislelizumab
Disitamab Vedotin
Other group
Description:
Disitamab Vedotin 120mg IV on day 1 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy.
Treatment:
Drug: Disitamab Vedotin

Trial contacts and locations

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Central trial contact

Hailong Hu

Data sourced from clinicaltrials.gov

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