Expanded Access Study of Atezolizumab for Advanced or Metastatic Urothelial Cancer After Platinum Chemotherapy Failure
Sponsor: Genentech, Inc.
ClinicalTrials ID:NCT02589717
This study provides access to the drug atezolizumab for patients with advanced or metastatic urothelial cancer that has worsened after treatment with platinum-based chemotherapy.
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Program Overview
This study is designed to offer the drug atezolizumab to patients with advanced or metastatic urothelial cancer, which includes cancer of the bladder, ureters, renal pelvis, and urethra. The study is for those whose cancer has progressed despite previous treatment with platinum-based chemotherapy, or who cannot tolerate such treatments. It is an open-label, single-arm study, meaning all participants will receive atezolizumab, and there is no placebo group.
Eligibility Criteria
Inclusion Criteria
- Must be able to follow the study requirements.
- Have advanced or metastatic urothelial cancer confirmed by lab tests.
- Cancer must have worsened during or after treatment with at least one platinum-based chemotherapy regimen, such as gemcitabine and cisplatin.
- Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Expected to live at least 12 more weeks.
- Have adequate blood and organ function based on recent lab tests.
- Women who can become pregnant must agree to use effective non-hormonal birth control during the study and for 90 days after the last dose.
Exclusion Criteria
- Have participated in another clinical trial or received an investigational drug within 28 days before joining this study.
- Have received chemotherapy within 14 days before joining the study.
- Have received radiotherapy within 7 days before joining the study.
- Have cancer that has spread to the brain or have symptoms from such spread.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have significant heart disease or recent heart attack.
- Have had severe infections or been hospitalized for infections within 4 weeks before joining the study.
- Have taken antibiotics by mouth or IV within 14 days before joining the study.
- Have had major surgery within 4 weeks before joining the study.
- Have severe allergies to similar drugs or components of atezolizumab.
- Have active hepatitis B or tuberculosis.
- Have received a live vaccine within 4 weeks before joining the study.
- Have taken drugs that stimulate the immune system or suppress it within a certain time before joining the study.
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