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.

The purpose of this study is to evaluate the effectiveness and safety of belzutifan (Welireg, a type of targeted therapy) monotherapy and belzutifan plus palbociclib (Ibrance, a type of targeted therapy) combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. Part 1 will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by increasing the dose. Part 2 will evaluate the effectiveness and safety of belzutifan plus palbociclib at the dosage level determined in Part 1. This study has 2 main treatment arms: Arm A: Belzutifan alone Participants receive belzutifan 120 mg by mouth (orally, PO) once daily until progressive disease or discontinuation. Pills are 40 mg tablets (3 tablets = 120 mg). Arm B: Belzutifan + Palbociclib Participants receive belzutifan 120 mg by mouth once daily PLUS palbociclib by mouth once daily at varying dose levels (75 mg, 100 mg or 125 mg) for 21 days (followed by 7 days off for a 28 day cycle) until progressive disease or discontinuation.

This is a Phase I/II, open-label, multi-center study of axitinib (Inlyta, a type of targeted therapy) in combination with nivolumab (Opdivo, a type of immunotherapy) in patients with previously treated and untreated advanced renal cell carcinoma (RCC). This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the effectiveness of the combination in two parallel expansion cohorts in both previously treated and treatment naïve patients. All patients in all phases of this study will receive both drugs, at various doses. Axitinib is taken orally (by mouth) twice daily, although dose and dosing schedule may vary. Nivolumab is given intravenously (IV), dose and dosing schedule may vary.

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab (Opdivo), ipilimumab (Yervoy), pembrolizumab (Keytruda), and avelumab (Bavencio), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib (Inlyta, a type of targeted therapy) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer. This study has 2 treatment arms: Arm A: Systemic Therapy Only Patients receive intravenous (IV) immunotherapy with one or two immunotherapy drugs with or without oral Axitinib. Dosing schedule and regimen will be provided by the treating physician. Arm B: Nephrectomy and Systemic Therapy Patients receive intravenous (IV) immunotherapy with one or two immunotherapy drugs with or without oral Axitinib. Dosing schedule and regimen will be provided by the treating physician. Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches.

This trial is a prospective, observational study is to understand the cancer management and health-related quality of life in patients with metastatic renal cell carcinoma (mRCC) in routine real-world clinical practice in the United States, including both community and academic treatment settings. Primarily, the study will evaluate patient experience through collection of patient reported outcomes (PROs). The study will also collect and assess information on the therapies used such as first-line treatment selection, treatment sequence and duration, the drivers of physician selection of particular agents, and discontinuation of therapies. The primary objective is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy. Patients will be identified and undergo consent and baseline assessments, including research blood collection and processing, by the study site team, this baseline visit will be their only clinic visits per protocol. All other visits are standard of care visits and outside the scope of the study.

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, activity, anti-tumor activity, and effectiveness of TT-10 (a type of targeted therapy) in subjects diagnosed with advanced Renal cell cancer (RCC) and castrate resistant prostate cancer (CRPC) who have failed or are not eligible for standard of care treatment. All patients will receive treatment with TT-10 orally administered (by mouth, po) twice daily starting at 10 mg and will be increased to 200 mg (additional dose levels maybe explored, if appropriate).

This study will evaluate the effectiveness, safety, and actions of tobemstomig (also known as RO7247669, a type of immunotherapy) in combination with axitinib (Inlyta, a type of targeted therapy) alone or with tiragolumab (anti-TIGIT, a type of immunotherapy) and axitinib, as compared to pembrolizumab (Keytruda, a type of immunotherapy) and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC). This study has 3 arms: Arm A: Tobemstomig + Axitinib Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID). Arm B: Tobemstomig + Tiragolumab + Axitinib Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID. Arm C: Pembrolizumab + Axitinib Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.

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.

Genitourinary cancers are some of the most common types of cancer. They are lethal when they spread. The drug M7824 blocks the paths that cancer cells use to stop the immune system from fighting cancer. The drug M9241 triggers the immune system to fight cancer. Researchers want to learn if these drugs can help fight these cancers when given with and without Stereotactic Body Radiation Therapy (SBRT) radiation. This study has 3 treatment arms: Arm A: Treatment with M7824 and deescalating (decreasing) doses of M9241, if appropriate Drug: M7824 1200 mg administered intravenously (IV) in clinic every two weeks while on M9241 and with or without SBRT Drug: M9241 an initial dose of 16.8 mcg/kg administered subcutaneously (SC or SQ) every 4 weeks while on M7824 and with or without SBRT Arm B: Treatment with M7824 and deescalating doses of M9241 (if appropriate) with sequential SBRT Drug: M7824 1200 mg administered IV every two weeks while on M9241 and with or without SBRT Drug: M9241 an initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT Radiation: Stereotactic body radiation therapy (SBRT) a fixed dose of 8 Gy x 3 fractions sequential or concurrent with M7824 and M9241 Arm C: Treatment with M7824 and deescalating doses of M9241 (if appropriate) with concurrent SBRT Drug: M7824 1200 mg administered IV every two weeks while on M9241 and with or without SBRT Drug: M9241 an initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT Radiation: Stereotactic body radiation therapy (SBRT) a fixed dose of 8 Gy x 3 fractions sequential or concurrent with M7824 and M9241

This phase III trial compares the effect of stero-ablative radiotherapy (SAbR) followed by standard of care systemic therapy, to standard of care systemic therapy alone, in patients with kidney cancer that has spread from where it first started (primary site) to a limited (2-5) number of places in the body (metastatic). Study doctors want to find out if this approach is better or worse than the usual approach for metastatic kidney cancer. The usual approach is defined as the care most people get for metastatic kidney cancer which includes systemic therapy such as immunotherapy (given through the veins) and/or small molecular inhibitor (tablets taken by mouth). Radiotherapy uses high energy x-rays to kill cancer cells and shrink tumors. SAbR uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving SAbR prior to systemic therapy may kill more tumor cells than the usual approach, which is systemic therapy alone. This study has 2 arms: Arm A: Standard of care Patients receive standard of care systemic therapy on study. Patients undergo CT or MRI throughout the trial. Arm B: Standard of care + SAbR Patients undergo repeated SAbR until progression and then receive standard of care systemic therapy on study. Patients undergo CT or MRI throughout the trial.

This is a study of vobramitamab duocarmazine (MGC018, a type of targeted therapy) in combination with lorigerlimab (a type of immunotherapy). The study is designed to characterize safety, tolerability, drug activity, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including metastatic castration resistant prostate cancer (mCRPC) and renal cell carcinoma (RCC) will be enrolled. All participants will receive treatment. Vobramitamab duocarmazine and lorigerlimab will be given intravenously (IV) once every 4 weeks. Dosage level will be provided by the treatment team.

This study is a randomized, open label, multicenter Phase II trial to evaluate the effectiveness and safety of botensilimab (a new type of immunotherapy) and balstilimab (a new type of immunotherapy) compared to ipilimumab (Yervoy, a type of immunotherapy) and nivolumab (Opdivo, a type of immunotherapy) in treatment naïve patients with metastatic clear cell renal cell carcinoma (ccRCC). This study has 2 treatment arms: Arm A: botensilimab and balstilimab Subjects will receive 2 cycles of induction treatment with each cycle lasting 6 weeks. Cycle 1 will consist of botensilimab 75mg IV (intravenously) in combination with balstilimab 450mg IV on Day 1 and Day 22. Cycle 2 will consist of balstilimab 450mg IV ONLY on Day 1 and Day 22. Botensilimab will NOT be given in Cycle 2. Subjects will receive 7 cycles of maintenance treatment with each cycle lasting 12 weeks. Cycles 3 and 4 will consist of botensilimab 75mg IV on Day 1 in combination with balstilimab 450mg IV on Day 1, 22, 43 and 64. Cycles 5-9 will consist of balstilimab alone 450 mg IV on Day 1, 22, 43 and 64. Arm B: ipilimumab and nivolumab Subjects will receive 2 cycles of induction treatment with each cycle lasting 6 weeks. Cycle 1 and 2 will consist of ipilimumab 1 mg/kg IV and nivolumab 3 mg/kg on Day 1 and 22. Subjects will receive 7 cycles of maintenance treatment with each cycle lasting 12 weeks. Nivolumab 480mg IV will be given on Day 1, 29 and 57 of each cycle (every 4 weeks).

This phase II trial compares the effect of atezolizumab (Tecentriq, a type of immunotherapy) in combination with usual treatment with cabozantinib (Cabometyx, a type of targeted therapy) to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Immunotherapy, such as atezolizumab, may help body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is a type of targeted therapy that works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma. This study has 2 arms: Arm A: Cabozantinib alone Patients receive cabozantinib S-malate orally (by mouth or PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Arm B: Cabozantinib + Atezolizumab Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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 first in human study is being done to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of NDI-101150 (a type of targeted therapy) given alone (as monotherapy) or in combination with pembrolizumab (Keytruda, a type of immunotherapy). The study will also investigate the safety, activity, and preliminary antitumor effects of NDI-101150 given alone or in combination with pembrolizumab in adult patients with advanced solid tumors. This study has 2 treatment arms: Arm A: NDI-101150 alone Patients in escalation and expansion will receive NDI-101150 capsules orally (by mouth or PO) once daily continuously in 4-week cycles (28 days). Arm B: NDI-101150 + pembrolizumab Patients in escalation and expansion phase will receive NDI-101150 capsules orally once daily continuously in 3-week cycles (21 days), along with pembrolizumab given intravenously (IV infusion) at a dose of 200 mg every 3 weeks.

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.

Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments. Better treatments are needed. Most patients with advanced clear cell RCC are treated with immunotherapy and targeted therapy. There are few options for patients who have progressed on these therapies. There is currently no widely accepted standard treatment for patients with papillary renal cell carcinoma, although some patients may benefit from targeted therapy. Preclinical data suggest that inhibitors of CDK 4/6 (targeted therapy) might be active in kidney cancer and that these agents might act synergistically with immunotherapy. The objective of this study is to the safety and effectiveness of combining palbociclib (a type of targeted therapy inhibiting CDK4/6) and sasanlimab (a type of immunotherapy). All participants receive treatment with palbociclib given by mouth (PO, orally) + sasanlimab given by subcutaneous injection (sc or sq). Dosage and dosing schedule will be provided by the treatment team.