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

NCT ID: NCT05495724

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

Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Tislelizumab
Disitamab vedotin

Conditions: Keywords:
Disitamab Vedotin
Tislelizumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Disitamab Vedotin Tislelizumab
Description: 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.
Arm group label: Disitamab Vedotin and Tislelizumab

Other name: KEYNOTE-057

Intervention type: Drug
Intervention name: Disitamab Vedotin
Description: Disitamab Vedotin
Arm group label: Disitamab Vedotin

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.

Criteria for eligibility:
Criteria:
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: 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Medical University Second Hospital

Address:
City: Tianjin
Zip: 300211
Country: China

Status: Recruiting

Contact:
Last name: Hailong Hu

Phone: +86-13662096232
Email: hhllove2004@163.com

Investigator:
Last name: Hailong Hu, MD,PhD
Email: Principal Investigator

Start date: July 23, 2021

Completion date: July 2025

Lead sponsor:
Agency: Tianjin Medical University Second Hospital
Agency class: Other

Source: Tianjin Medical University Second Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05495724

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