An open-label multi-center phase 2 study of Genexol-PM and atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 97
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate based on RECIST 1.1
- Secondary Outcome Measures
Name Time Method 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