This study is NOT currently recruiting participants.
Number
000782-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Pregnant Women
Keywords
Renal Cell Carcinoma; Transitional Cell Carcinoma Of The Urothelium; Bladder Cancer; Immunotherapy; Avelumab; Atezolizumab
Recruitment Keyword(s)
None
Condition(s)
Neoplasms
Investigational Drug(s)
Atezolizumab XL092
Investigational Device(s)
Intervention(s)
Drug: avelumab Drug: atezolizumab Drug: XL092
Supporting Site
National Cancer Institute
Substances called receptor tyrosine kinases (RTKs) play important roles in the functions of body cells, including how they reproduce. When RTKs are out of balance in the body, cells may proliferate too quickly, and cancers may develop. Drugs that target the activity of RTKs have been useful for treating cancer. XL092 is a new drug of this type that shows promise for treating certain cancers.
Objective:
To study how well XL092 works against cancer, alone or combined with other drugs.
Eligibility:
People aged 18 years and older with advanced cancer of the kidneys or urinary tract.
Design:
Participants will undergo screening. They will have a physical exam, including blood and urine tests. They will have tests to measure the function of their heart. They will undergo imaging scans of their tumors. They will provide a tumor biopsy.
Treatment will be administered in 28-day cycles. XL092 comes in pills taken by mouth. Participants will take XL092 every day. They will take the pills at home and record their doses in a diary. They will come to a clinic for an exam once every 2 weeks for the first 9 weeks. After that, they will come once every 4 weeks. Some of the screening tests will be repeated at each visit.
Some participants will also receive other drugs (atezolizumab or avelemab) administered through a vein in their arm. Those who get atezolizumab will come to the clinic once every 3 weeks. Those getting avelemab will come to the clinic once every 2 weeks.
Participants may be in the study for 6 months up to 2 years.
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ELIGIBILITY: -Age >= 18 years -Histologically confirmed inoperable locally advanced or metastatic renal cell carcinoma (RCC) with clear cell histology (including those with a sarcomatoid component) or non-clear cell histology that has radiographically progressed following treatment with at least one prior systemic anticancer regimen. -Histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (UC) (including the renal pelvis, ureter, urinary bladder, or urethra). Participants must have: --received at least 4 cycles but not more than 6 cycles of first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin OR --progressed during or after PD-1/PD-L1 targeting immune checkpoint inhibitor therapy OR --progressed during or after prior first-line platinum-based combination therapy
-Age >= 18 years
-Histologically confirmed inoperable locally advanced or metastatic renal cell carcinoma (RCC) with clear cell histology (including those with a sarcomatoid component) or non-clear cell histology that has radiographically progressed following treatment with at least one prior systemic anticancer regimen.
-Histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (UC) (including the renal pelvis, ureter, urinary bladder, or urethra). Participants must have:
--received at least 4 cycles but not more than 6 cycles of first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin OR
--progressed during or after PD-1/PD-L1 targeting immune checkpoint inhibitor therapy OR
--progressed during or after prior first-line platinum-based combination therapy
Principal Investigator
Referral Contact
For more information: