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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