Kidney Cancer Trials

The purpose of this study is to assess the safety and effectiveness of the investigational drugs ALLO-647 (a type of immunotherapy) and ALLO-316 (a type of immunotherapy) in people with advanced clear cell renal cell (kidney) cancer. ALLO-647 is an antibody designed to target some kinds of white blood cells. It will be given in combination with a standard chemotherapy regimen (fludarabine and cyclophosphamide) to prepare patients to receive ALLO-316. ALLO-316 is made in a laboratory from white blood cells (T cells) collected from a healthy donor and is a form of cellular therapy. These cells are modified (“CAR T cells”) to help the immune system recognize and kill kidney cancer cells. ALLO-647 will help ALLO-316 work better by reducing the immune system’s ability to fight the modified T cells. Participants in this study will receive standard chemotherapy with or without ALLO-647, followed by ALLO-316. All medications are given intravenously (IV) in clinic. Dosing and dosing schedule will be provided by the treating physician.

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy, such as nivolumab (Opdivo) and ipilimumab (Yervoy), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Targeted therapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body. This study has 2 arms: Arm A: Nivolumab INDUCTION: Patients receive nivolumab intravenously (IV) in clinic over 30 or 60 minutes PLUS ipilimumab IV over 60 minutes on day 1 of every 21 day cycle, for up to 4 cycles. TREATMENT: Patients receive nivolumab IV over 30 or 60 minutes on day 1 of every 28 day cycle. Arm B: Nivolumab + Cabozantinib INDUCTION: Patients receive nivolumab intravenously (IV) in clinic over 30 or 60 minutes PLUS ipilimumab IV over 60 minutes on day 1 of every 21 day cycle, for up to 4 cycles. TREATMENT: Patients receive nivolumab IV over 30 or 60 minutes on day 1 of every 28 day cycle PLUS cabozantinib orally (by mouth or PO) daily on days 1-28.

This study will compare the efficacy and safety of belzutifan (a type of targeted therapy) plus lenvatinib (Lenvima, a type of targeted therapy) versus cabozantinib (Cabometyx, a type of targeted therapy) in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan plus lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. This study has 2 treatment arms: Arm A: Belzutifan + Lenvatinib Belzutifan 120 mg and lenvatinib 20 mg orally (PO) once a day (QD). Arm B: Cabozantinib Cabozantinib 60 mg orally once a day

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.

This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 (a type of immunotherapy) in subjects with advanced solid tumors, including bladder and kidney cancer. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK, how the drug moves through your body) and immunogenicity (the effect on the immune system), and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. All subjects will receive study drug. Specific dosing will be provided by your treating physician. PSB205 will be administered on day 1 of every 21-day cycle (3 weeks) by intravenous (IV) infusion.

The purpose of this study is to test the safety of an investigational drug called CFI-402411 (a type of targeted therapy) alone and in combination with pembrolizumab (Keytruda, a type of immunotherapy) and to study its effects in patients with advanced solid tumors (including bladder and kidney cancer) who have progressed following previous therapies. This study has 2 treatment arms: Arm A: CFI-402411 alone CFI-402411 is administered orally (po or by mouth) once daily. The starting dose is 80 mg/day. Specific dose will be provided by your treating physician. Arm B: CFI-402411 + pembrolizumab CFI-402411 is administered orally (po or by mouth) once daily. The starting dose is 80 mg/day. Specific dose will be provided by your treating physician. Pembrolizumab will be given at, 200 mg administered as an intravenous (IV) infusion over 30 minutes every 3 weeks.

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.

Metastatic renal cell carcinoma (RCC) is an incurable condition. Current therapy for this disease consists of targeted therapies and immunotherapies. Long-term survival can be achieved however, of those patients treated with immunotherapy, three quarters will not respond at all and only 5-8% will achieve a complete and long term response. Gene transfer is a new cancer therapy that takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells. Our team isolated a tumor-specific cytotoxic T lymphocyte (CTL, a type of white blood cell that kills cancer cells) line from peripheral blood obtained after an allogeneic transplant from a patient who showed prolonged tumor regression. We identified a HERV-E derived antigen expressed in the patient s ccRCC cells to be the target of this T-cell clone. Remarkably, we found this HERV-E was expressed in the majority of ccRCC cells with no expression in normal tissues. This research protocol is designed to evaluate the safety and effectiveness of the infusion of HERV-E T cells. Treatment: • Participants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant’s other arm. • Participants cells will be grown in the lab and genetically changed. • Participants will stay in the hospital 2-3 weeks. In the hospital participants will: • Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest. • Get the changed cells via catheter. • Get a drug to increase white blood cell count and one to make the cells active. • Recover for about a week. • Have lab and blood tests. After leaving the hospital, participants will: • Take an antibiotic for several months. • Have leukapheresis. • Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam. • Participants will have follow-up checks for up to 15 years.

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 is a multi-arm, multicenter, open-label, combination cohort study designed to evaluate IPI-549 (Eganelisib, a type of immunotherapy) a first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated. IPI-549 will be administered in combinations with Tecentriq (Atezolizumab, a type of immunotherapy) and Avastin (Bevacizumab, a type of targeted therapy) patients with locally advanced and/or metastatic renal cell carcinoma (RCC). There is one treatment arm for patients with renal cell cancer: IPI-549 (eganelisib) IPI-549 is an orally-administered capsule that will be dosed at either 20mg/day, 30mg/day, or 40mg/day to patients. Atezolizumab Atezolizumab 840 mg of the drug will be administered intravenously (IV) on days 1 and 15 in combination of each 28-day cycle OR 1200mg will be administered IV on day 1 of each 21-day. Bevacizumab Bevacizumab will be administered at 15 mg/kg IV on day 1 of each 21-day cycle.

The purpose of this study is to first, in Part 1, to determine the safety of nivolumab (Opdivo, a type of immunotherapy), bempegaldesleukin (BEMPEG: NKTR-214, a type of targeted therapy), and Tyrosine Kinase Inhibitor (TKI, a type of targeted therapy) combination and then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and cabozantinib when compared with nivolumab and cabozantinib in participants with previously untreated kidney cancer that has advanced or has spread. This study has 3 potential treatment arms: Arm A: Nivolumab + Bempegaldesleukin + Axitinib Nivolumab and Bempegaldesleukin are given intravenously (IV) in clinic. Axitinib (Inlyta, a type of targeted therapy) is an oral drug taken by mouth (PO). Dosing and schedule for all medications will be provided by the treatment team. Arm B: Nivolumab + Bempegaldesleukin + Cabozantinib Nivolumab and Bempegaldesleukin are given intravenously (IV) in clinic. Cabozantinib (Cabometyx, a type of targeted therapy) is an oral drug taken by mouth (PO). Dosing and schedule for all medications will be provided by the treatment team. Arm C: Nivolumab + Cabozantinib Nivolumab is given intravenously (IV) in clinic. Cabozantinib (Cabometyx, a type of targeted therapy) is an oral drug taken by mouth (PO). Dosing and schedule for all medications will be provided by the treatment team.

The purpose of this study is to assess the effectiveness and safety of oral belzutifan (MK-6482, Welireg, a type of targeted therapy) plus intravenous (IV) pembrolizumab (MK-3475, Keytruda, a type of immunotherapy) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). This study has 2 treatment arms: Arm A: Belzutifan + Pembrolizumab Participants receive belzutifan 120 mg orally (by mouth, PO) once daily for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks for up to 9 administrations (up to approximately 54 weeks). Arm B: Placebo + Pembrolizumab Participants receive placebo orally once daily for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once every 6 weeks for up to 9 administrations (up to approximately 54 weeks).

This study will be comparing tivozanib (Fotivda, a type of targeted therapy) in combination with nivolumab (Opdivo, a type of immunotherapy) to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). The study is designed to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), duration of response (DoR), and safety of tivozanib and the combination of tivozanib with nivolumab. This study has 2 treatment arms: Arm A: Tivozanib + Nivolumab Subjects will receive 1.34 mg of tivozanib once daily (QD) by mouth (orally, PO) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks intravenously (IV) on day 1 of each 4 week cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment [for nivolumab] whichever occurs first. Arm B: Tivozanib Subjects will receive 1.34 mg of tivozanib once daily (QD) by mouth for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met.

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, preliminary antitumor activity, and effects of XL092 (a type of targeted therapy) administered alone, in combination with atezolizumab (Tecentriq, a type of immunotherapy), and in combination with avelumab (Bavencio, a type of immunotherapy) to subjects with advanced solid tumors. This study has 3 treatment arms: Arm A: XL092 alone XL092 will be given orally (by mouth or PO). Dosage and dosing schedule to be provided by treatment team. Arm B: XL092 + Atezolizumab XL092 will be given orally (by mouth or PO). Dosage and dosing schedule to be provided by treatment team. Atezolizumab is administered as a 1200 mg IV (intravenously) infusion once every 3 weeks. Arm C: XL092 + Avelumab XL092 will be given orally (by mouth or PO). Dosage and dosing schedule to be provided by treatment team. Avelumab is administered as an 800 mg IV infusion once every 2 weeks.

At the present time, there are no drugs that have been proven to work in patients with papillary kidney cancer that has spread (metastasized) beyond the kidneys. Researchers are interested in determining whether the combination of the drugs bevacizumab (Avastin, a type of targeted therapy) and erlotinib (Tarceva, a type of targeted therapy) can be used to treat metastatic papillary kidney cancer. Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) is an inherited type of papillary kidney cancer (it runs in families). Papillary kidney cancer can also occur sporadically, or without a family connection. More research is needed to determine whether treatments for papillary kidney cancer, such as bevacizumab and erlotinib, work in inherited or sporadic types of kidney cancer, and if so, whether there are any differences. The objective of the study is to determine the effectiveness of the combination of bevacizumab and erlotinib as a treatment for patients with metastatic HLRCC kidney cancer and metastatic kidney cancer not associated with HLRCC (or sporadic papillary RCC). The study has 1 treatment arm: All patient will receive a fixed starting dose of bevacizumab 10 mg/kg intravenously (IV) every 2 weeks and erlotinib 150 mg/day by mouth (orally or PO).

This is a Phase 1/2 open label multicenter study of NKT2152 (a type of targeted therapy). Phase 1 is a first in human (FIH) dose escalation study in patients aged 18 years or older with clear cell renal carcinoma (ccRCC) who have exhausted available standard therapy as determined by the investigator. Eligible patients will have received <=4 prior lines of therapy. The goal of the Phase 1 portion is to identify the maximum tolerated dose and/or the recommended Phase 2 Dose of NKT2152. The Phase 2 portion will evaluate the effectiveness of NKT2152 in ccRCC. All subjects will receive NKT2152 taken once daily by mouth (orally or PO). Dosage will be provided by treatment team.

In this study, the Phase Ib portion aims to establish safety and tolerability of ARRY-614 (a type of targeted therapy) with either nivolumab (Opdivo, a type of immunotherapy) or ipilimumab (Yervoy, a type of immunotherapy) and to determine a recommended phase II dose of ARRY-614 in combination with either nivolumab or nivolumab plus ipilimumab immunotherapy in patients with selected advanced solid tumors. The Phase II portion will estimate the effectiveness of ARRY-614 in combination with either nivolumab or ARRY-614 + nivolumab plus ipilimumab immunotherapy in patients with with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and renal cell carcinoma (RCC), and melanoma. For Renal Cell Carcinoma (RCC), this study has one treatment arm: ARRY-614 plus nivolumab plus ipilimumab Participants with RCC will receive ARRY-614 combined with nivolumab plus ipilimumab. The recommended Phase II dose of ARRY-614 (to be determined) by mouth (orally or PO) daily in 4-week cycles (± 3 days). Nivolumab will be dosed intravenously (IV) according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed intravenously (IV)according to FDA-approved dosing schedule.