None listed
Conditions
Interventions
Drug : 1) Genexol PM will be administered every three weeks with a capacity of 220 mg/m2 and atezolizumab at 1200 mg by intravenous infusion
2) Depending on toxicity, Genexol PM can be reduced to 180
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pathologic confirmed locally advanced and/or metastatic urotheilal cancer 2) Failure of previous platinum-based chemotherapy due to disease progression or intolerance 3) Available infomred conset with sign for study participation 4) The ability to comply with the clinical trial plan 5) 19 years old or older 6) ECOG performance status 0 or 1 7) Measurable diseases based on RECIST v1.1 (including at least one target lesion) 8) Proper hematologic function and peripheral organ function defined as the results of laboratory tests collected within 14 days before the commencement of the drug administration 9) Negative for HIV, HBV, and HCV infection of activity 10) In the case of fertile women: agree to maintain abstinence (no sexual intercourse between sexes), agree to use contraception, and refrain from ovum donation 12) In the case of men: maintain abstinence (no sexual intercourse), agree to use birth control and refrain from sperm donation ·Available tumor tissue exists and is willing to provide
Exclusion criteria
Exclusion criteria: 1) Previous use of immune checkpoint co-stimulators or checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies 2) Previously using Genexol PM or paclitaxel 3) Radiotherapy of bone metastasis or soft tissue lesions should be completed 14 days prior to base line imaging. 4) Hormone replacement therapy or oral contraception 5) Former hematopoietic stem cells or solid organs transplant 6) Systemic immunosuppressants are expected to be required during the treatment or administration of systemic immunosuppressants (when used more than 10mg / day as Prenisolone or equivalent doses, including cyclophosphamide, azatioprine, methotrexate, thalidomide, and anti-cancer immunosuppressants) within two weeks prior to the commencement of the medication. 7) Uncontrolled pleural effusion, pericardial effusion, and peritoneal effusion that require repetitive drainage 8) Uncontrolled hypercalcemia 9) Uncontrolled brain metastasis 10) Previous history of leptomeningeal disease 11) Previous history of active autoimmune disease or immunodeficiency 12) Active interstitial pneumonitis 13) History of cancer other than urothelial carcinoma within two years before screening 14) Active tuberculosis 15) Severe infection within 14 days prior to the commencement of test medication, including hospitalization, bacteremia or severe pneumonia due to infection complications 16) Treatment of oral or administered antibiotics within seven days before the commencement of the trial 17) Significant cardiovascular diseases such as New York Heart Association (New York Heart Association) heart disease (grade III or higher), myocardial infarction or cerebrovascular accident, unstable arrhythmia or unstable angina 18) Uncontrolled hypertension 19) Bleeding more than grade 3 within 14 days before treatment start 20) A large surgical procedure is expected to be required during treatment or within 14 days before treatment start, not for diagnostic goal 21) Adverse events caused by previous chemotherapy that have not improved below grade 1, except for all grades of hair loss and peripheral neuropathy under grade 2 22) Other diseases, metabolic dysfunction, physical examination findings or clinical laboratory findings that may be considered taboo, affect the interpretation of the results, impair the patient's ability to participate in the test, or put the patient at high risk of administration complications 23) A history of severe allergies to chimera or humanized antibodies or fused proteins 24) Known irritability of Chinese hamster ovarian cell preparation or recombinant human antibodies 25) Known intolerance to all test drugs or their siblings 26) Known intolerance to all drugs needed for premedication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate based on RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progrssion-free survival based on RECIST 1.1;Duration of response based on RECIST 1.1;Safety;Toxicity based on NCI-CACAE v5.0 | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Gon Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed