Study on Durvalumab With or Without Tremelimumab Compared to Standard Chemotherapy in Urothelial Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT02516241
This clinical trial is comparing the effectiveness of the drug Durvalumab, alone or with Tremelimumab, against standard chemotherapy in patients with advanced urothelial cancer. The study aims to determine which treatment is more effective and safer for patients.
Patient Parameters
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Program Overview
This study is testing whether the drug Durvalumab, either by itself or combined with another drug called Tremelimumab, is more effective than the usual chemotherapy for patients with advanced urothelial cancer. Urothelial cancer affects areas like the bladder and urethra. Participants will be randomly assigned to receive either the new drug combination or the standard chemotherapy. The study will monitor patients for up to two years to see how well the treatments work and how safe they are.
Description
This clinical trial is designed to find out if the drug Durvalumab, alone or with Tremelimumab, can be a better first treatment option than the usual chemotherapy for patients with advanced urothelial cancer. Urothelial cancer is a type of cancer that occurs in the urinary system, including the bladder and urethra.
Participants in the study will be randomly divided into three groups. One group will receive Durvalumab alone, another group will receive Durvalumab with Tremelimumab, and the third group will receive the standard chemotherapy treatment, which includes drugs like cisplatin and gemcitabine. The choice of chemotherapy will depend on whether the patient can tolerate cisplatin.
The study will continue until the cancer progresses, the patient experiences unacceptable side effects, or the patient decides to stop participating. Researchers will follow the participants for up to two years to evaluate the effectiveness and safety of the treatments.
Eligibility Criteria
Inclusion Criteria
- Have advanced urothelial cancer that cannot be removed by surgery and have not received chemotherapy for this cancer before.
- Be eligible or ineligible for cisplatin-based chemotherapy. Ineligibility for cisplatin is defined by certain health conditions, such as reduced kidney function, hearing loss, nerve damage, or severe heart failure.
- Have a known PD-L1 status of the tumor, confirmed by a specific lab test before starting the study.
Exclusion Criteria
- Have previously received treatments that affect the immune system, such as certain cancer vaccines or other immune-targeting drugs.
- Have had an organ transplant that requires taking immune-suppressing drugs.
- Have active or past autoimmune or inflammatory diseases, with some exceptions like stable thyroid conditions or controlled celiac disease.
- Have brain or spinal cord cancer spread unless stable and off steroids for at least 14 days before starting the study.
- Have active infections like tuberculosis, hepatitis B or C, or HIV.
- Have used immune-suppressing medications within 14 days before starting the study, with some exceptions for low-dose or specific types of steroids.
- Have received a live vaccine within 30 days before starting the study and should not receive one during the study or for 30 days after the last dose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90095 | Los Angeles | California |
| Research Site | 94305 | Stanford | California |
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 06520 | New Haven | Connecticut |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 30322 | Atlanta | Georgia |
| Research Site | 40202 | Louisville | Kentucky |
| Research Site | 02215 | Boston | Massachusetts |
| Research Site | 48109 | Ann Arbor | Michigan |
| Research Site | 48201 | Detroit | Michigan |
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