Kidney Cancer Trials

Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs, sacituzumab govitecan (SG, a type of targeted chemotherapy) and atezolizumab (Tecentriq, a type of immunotherapy), are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with rare GU cancers. The objective of this study is to determine clinical effectiveness of sacituzumab govitecan (SG), either alone or in combination with atezolizumab in participants with rare metastatic non-prostate genitourinary tumors. This study has 2 treatment arms: Arm A: Sacituzumab govitecan Sacituzumab govitecan is administered intravenously (IV) at 10 mg/kg on days 1 and 8 of each 21-day cycle. Arm B: Sacituzumab govitecan PLUS Atezolizumab Sacituzumab govitecan is administered intravenously (IV) at 10 mg/kg on days 1 and 8 of each 21-day cycle PLUS Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.

This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other cancer outcomes including local control, locoregional and systemic failure, progression free and overall survival. The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the standard treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, the remaining part of the affected kidney, bowels, spine and liver. With this technology, both kidneys could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function. This study has 1 treatment arm (all subjects will receive treatment): Proton Stereotactic Body Radiation therapy (SBRT) Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks.

This study is being done to determine if the investigational radiotracer called 111In-XYIMSR-01 is helpful in detecting clear cell renal cell carcinoma tissue in your body when used during a SPECT-CT Scan. This is an imaging study only. No treatment is provided.

The researchers are doing this study to find out whether the combination of abemaciclib (a type of targeted therapy) and cabozantinib (a type of targeted therapy) is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants. This study has 1 treatment arm. All subjects will receive treatment. Arm A: Abemaciclib and Cabozantinib Abemaciclib is taken twice daily by mouth (orally, po) and Cabozantinib is taken once daily by mouth. Dosage will be provided by treatment team.

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan (a type of targeted therapy) versus placebo when each is given in combination with cabozantinib (Cabometyx, a type of targeted therapy) in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior immunotherapy. This study has 2 treatment arms: Arm A: Casdatifan PLUS cabozantinib, both taken orally (by mouth, PO). Treatment dose and schedule to be provided by study team. Arm B: Placebo PLUS cabozantinib, both taken orally (by mouth, PO). Treatment dose and schedule to be provided by study team.

This is a single arm, single site, open-label Phase II study of the effects of oral olaparib (Lynparza, a type of targeted therapy, a PARP inhibitor) in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor (immunotherapy) or anti-VEGF therapy (targeted therapy). This study has 1 arm: Olaparib: Participants will be initially treated with olaparib 150 mg by mouth (PO) twice daily for one month. After one month of therapy, the dose will be increased to 300mg by mouth twice daily, if tolerated. Treatment will be continued until clinical and/or radiographic progression or unmanageable side effects requiring discontinuation of the drug.

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors (a type of targeted therapy). It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC. This study has 2 treatment arms: Arm A: Pembrolizumab Patients receive pembrolizumab intravenously (IV) on days 1 and 43 of each cycle, or on days 1, 22, 43 and 64 of each cycle. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Arm B: Pembrolizumab + tivozanib Patients receive pembrolizumab IV on days 1 and 43 of each cycle and tivozanib by mouth (orally, PO) once daily (QD) on days 1-21, days 29-49, and days 57-77 of each cycle for up to 6 months. Cycles repeat every 12 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of Pumitamig (a type of targeted therapy) alone or in combination with Ipilimumab (Yervoy, a type of immunotherapy) or Cabozantinib (Cabometyx, a type of targeted therapy) in participants with advanced Renal Cell Carcinoma (RCC). All participants will receive treatment. This study has 3 treatment arms: Arm A: Pumitamig alone Arm B: Pumitamig + Ipilimumab Arm C: Pumitamig + Cabozantinib Dosages and dosing schedules will be provided by the treatment site.

The purpose of this study is to evaluate the safety and tolerability of casdatifan (a type of targeted therapy) when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during, and casdatifan in combination with cabozantinib (Cabometyx, a type of targeted therapy) in participants with ccRCC. This study has 2 treatment regimens: Regimen 1: Casdatifan monotherapy Participants will receive casdatifan at various dose levels by mouth (orally, po) once or twice daily. Dosing and dosing schedule will be provided by treatment team. Regimen 2: Casdatifan + Cabozantinib Participants will receive casdatifan orally with cabozantinib. Dosing and dosing schedule will be provided by treatment team.

This phase II trial studies the effects of combination therapy with bevacizumab (Avastin, a type of targeted therapy), erlotinib (Tarceva, a type of targeted therapy), and atezolizumab (Tecentriq, a type of immunotherapy) in treating patients with hereditary leiomyomatosis and kidney cancer that has spread to other places in the body (advanced). Bevacizumab is in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Combination therapy with bevacizumab, erlotinib, and atezolizumab may stabilize or shrink advanced hereditary leiomyomatosis and kidney cancer. This study has one treatment arm: Bevacizumab + Atezolizumab + Erlotinib Patients receive bevacizumab intravenously (IV) over 30-90 minutes and atezolizumab IV over 30-90 minutes on day 1 of each cycle. Patients also receive erlotinib by mouth (orally or PO) once daily on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.