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

NCT05495724 | Unknown Phase 2

• 1 other identifier: TRUCE-04
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Disitamab Vedotin; Tislelizumab

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate

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

Secondary Outcomes (8)

• Progress Free Survival（PFS）

  up to 3 years

• Recurrence Free Survival（RFS）

  up to 3 years

• Cystectomy-Free Survival (CFS)

  up to 3 years

• Duration of Response (DOR)

  up to 3 years

• Event-Free Survival（EFS）

  up to 3 years

Study Arms (2)

Disitamab Vedotin and Tislelizumab

EXPERIMENTAL

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

Disitamab Vedotin

OTHER

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

Drug: Disitamab Vedotin

Interventions

Disitamab Vedotin Tislelizumab DRUG

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

Disitamab Vedotin and Tislelizumab

Disitamab Vedotin DRUG

Disitamab Vedotin

Disitamab Vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Interventions

disitamab vedotin

Study Officials

• Hailong Hu

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hailong Hu

CONTACT

+86-13662096232; hhllove2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: July 23, 2021
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CN (1)