Study on Durvalumab with Chemotherapy, Durvalumab and Tremelimumab with Chemotherapy, or Chemotherapy Alone for Unresectable Urothelial Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03682068
This clinical trial is testing different combinations of treatments, including durvalumab and tremelimumab with chemotherapy, to see if they are effective and safe for patients with advanced urothelial cancer that cannot be removed by surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if combining the immunotherapy drugs durvalumab and tremelimumab with standard chemotherapy is more effective than chemotherapy alone for treating advanced urothelial cancer. This type of cancer affects areas like the bladder and urethra and cannot be surgically removed. Participants will receive either the combination of immunotherapy and chemotherapy or chemotherapy alone to see which approach works better as a first treatment option.
Eligibility Criteria
Inclusion Criteria
- Have advanced urothelial cancer that cannot be removed by surgery, affecting areas like the bladder, ureters, or urethra.
- Have not received chemotherapy as the first treatment for this cancer. Previous treatments like chemoradiation or surgery are allowed if the cancer returned more than 12 months after the last treatment.
- Have at least one tumor that can be measured and has not been treated with radiation.
- Be in good overall health, able to carry out daily activities with little or no assistance.
- Have good organ and bone marrow function based on medical tests.
- Have a life expectancy of at least 12 weeks, as assessed by the doctor.
- For women, be post-menopausal or have a negative pregnancy test if of childbearing age.
Exclusion Criteria
- Have previously received certain types of immune therapy, except for specific cancer vaccines.
- Have a serious condition that requires medication to suppress the immune system.
- Have untreated cancer that has spread to the brain or spinal cord.
- Be eligible for surgery to remove the cancer during the study.
- Have medical reasons that prevent the use of platinum-based chemotherapy or allergies to the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 35294 | Birmingham | Alabama |
| Research Site | 93309 | Bakersfield | California |
| Research Site | 92835 | Fullerton | California |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 93901 | Salinas | California |
| Research Site | 93105 | Santa Barbara | California |
| Research Site | 96161 | Truckee | California |
| Research Site | 06520 | New Haven | Connecticut |
| Research Site | 20007 | Washington D.C. | District of Columbia |
| Research Site | 32806 | Orlando | Florida |
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