The following clinical trials represent a selection of key studies currently recruiting patients with renal cell carcinoma for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these clinical trials.

The purpose of this multicenter, double-blind, randomized, phase 3 study is to assess the efficacy and safety of belzutifan (Welireg) plus pembrolizumab (Keytruda) versus placebo plus pembrolizumab in the adjuvant treatment of patients with clear cell renal cell carcinoma (RCC) after nephrectomy. Patients aged ≥18 years with a histologically or cytologically confirmed diagnosis of clear cell RCC with or without sarcomatoid features; who have intermediate high-risk disease, high-risk disease, or M1 no evidence of disease; who have had a complete resection of the primary tumor and/or metastasectomy ≤12 weeks before randomization; and who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 may be eligible if other criteria are met. Eligible participants will be randomized to receive either belzutifan 120 mg orally (PO) once daily plus pembrolizumab 400 mg intravenously (IV) once every 6 weeks for up to approximately 54 weeks, or placebo once daily plus pembrolizumab 400 mg IV once every 6 weeks for up to approximately 54 weeks.

The primary outcome measure is disease-free survival, defined as the time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis or death due to any cause, whichever occurs first, up to approximately 66 months. Secondary outcome measures include overall survival (OS), the number of participants with at least 1 adverse event (AE) and the number of participants who discontinue study treatment due to an AE, and change from baseline in health-related quality of life per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. The study plans to enroll approximately 1600 patients throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05239728.

The purpose of this randomized, double-blind, placebo-controlled, phase 3 study is to evaluate the efficacy and safety of pazopanib (Votrient) with or without abexinostat (PCI-24781) in the treatment of patients with locally advanced unresectable or metastatic RCC. Patients aged ≥18 years with locally advanced unresectable or metastatic, histologically confirmed clear cell RCC per RECIST version 1.1; who have not received any previous vascular endothelial growth factor tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting; who have an ECOG performance status of 0 or 1; and who have received their last systemic treatment or dose of radiation at least 2 weeks before date of randomization may be eligible if other criteria are met. Eligible participants will be randomized (2:1) to receive pazopanib 800 mg PO on days 1 to 28 of each treatment cycle with or without abexinostat 80 mg PO twice daily on days 1 to 4, 8 to 11, and 15 to 18 of each 28-day cycle.

The primary outcome measure is progression-free survival (PFS) from date of randomization to date of first documentation of disease progression or death, up to approximately 4 years. Secondary outcome measures include PFS per RECIST version 1.1, OS, AEs per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5, objective response rate (ORR), duration of response (DOR), and mean change from baseline in Functional Assessment of Cancer Therapy Kidney System Index scores and in Functional Assessment of Chronic Illness Therapy scores. The study plans to enroll approximately 413 participants throughout the United States and worldwide. For more information, contact Sophia Paspal, PhD, at 1-610-405-5974 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Rahul Aggarwal, MD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03592472.

The purpose of this randomized, controlled, multicenter, open-label, phase 3 study is to compare the efficacy and safety of tivozanib (Fotivda) in combination with nivolumab (Opdivo) versus tivozanib alone in the treatment of patients with locally advanced or metastatic RCC with a clear cell component who have received 1 to 2 previous lines of therapy, one of which included an immune checkpoint inhibitor. Patients aged ≥18 years with radiographic disease progression during or following at least 6 weeks of treatment with an immune checkpoint inhibitor in either the first- or second-line treatment; who have measurable disease per RECIST version 1.1; and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible participants will be randomized (1:1) to receive either tivozanib 0.89 mg PO once daily for 3 weeks followed by 1 week off and nivolumab IV every 4 weeks on day 1 of each 4-week cycle, or tivozanib 1.34 mg PO once daily for 3 weeks followed by 1 week off.

The primary outcome measure is PFS from time of randomization to first documented objective tumor progression per RECIST version 1.1, or death due to any cause, whichever comes first. Secondary outcome measures include OS, ORR, DOR, and the number of participants with serious and nonserious AEs. This study plans to enroll approximately 326 participants throughout the United States and worldwide. For more information, contact the AVEO Clinical Trials Office at 1-857-400-0101 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04987203.

The purpose of this open-label, randomized, phase 3 study is to evaluate the efficacy and safety of pembrolizumab (Keytruda) in combination with belzutifan (Welireg) and lenvatinib (Lenvima) or pembrolizumab/quavonlimab (MK-1308) plus lenvatinib versus pembrolizumab and lenvatinib as first-line treatment of patients with advanced clear cell RCC. Patients aged ≥18 years with histologically confirmed clear cell RCC who have not received any previous systemic therapy for their disease; who have adequate organ function; and who are receiving bone resorptive therapy that must have been initiated at least 2 weeks before randomization may be eligible if other criteria are met. Eligible participants will be randomized to receive either pembrolizumab 400 mg IV every 6 weeks plus belzutifan 120 mg PO and lenvatinib 20 mg PO once daily; or pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) IV every 6 weeks plus lenvatinib 20 mg PO once daily; or pembrolizumab 400 mg IV every 6 weeks plus lenvatinib 20 mg PO once daily.

The primary outcome measures are PFS per RECIST version 1.1 and OS from date of randomization to death due to any cause. Secondary outcome measures include ORR, DOR, the number of participants who have at least 1 AE, and the number of participants who discontinue study treatment due to an AE. The study plans to enroll approximately 1653 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04736706.

The purpose of this open-label, randomized, 3-arm, multicenter, international phase 3 study is to assess the efficacy and safety of savolitinib (AZD6094) plus durvalumab (Imfinzi) versus sunitinib (Sutent) and durvalumab monotherapy in patients with previously untreated, metastatic or locally advanced, unresectable, and MET-driven papillary RCC. Patients aged ≥18 years with histologically confirmed unresectable or locally advanced or metastatic papillary RCC that has been centrally confirmed as MET-driven using a central laboratory–validated next-generation sequencing assay; who have not received previous systemic anticancer treatment in the metastatic setting or previous exposure to MET inhibitors or study drugs; who have a Karnofsky score >70; and who have a life expectancy ≥12 weeks at day 1 may be eligible if other criteria are met. Eligible participants will be randomized to receive savolitinib 600 mg PO once daily plus durvalumab 1500 mg IV every 4 weeks; sunitinib 50 mg PO once daily for 4 weeks on and 2 weeks off; or durvalumab 1500 mg IV every 4 weeks.

The primary outcome measure is PFS from date of randomization until disease progression or death due to any cause. Secondary outcome measures include OS, ORR, DOR, disease control rate, and PFS in comparison of savolitinib plus durvalumab relative to sunitinib and durvalumab monotherapies; and evaluation of plasma concentration of savolitinib and durvalumab monotherapy. The study plans to enroll approximately 220 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT05043090.

The purpose of this open-label, randomized, phase 3 study is to compare the efficacy of the standard treatment of nivolumab (Opdivo) and ipilimumab (Yervoy) followed by nivolumab alone with treatment of nivolumab and ipilimumab followed by nivolumab and cabozantinib (Cabometyx) in the treatment of patients with untreated, metastatic RCC. Patients aged ≥18 years with measurable, histologically documented clear cell RCC with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database criteria; who have a Karnofsky performance status ≥70%; and who have not received any previous treatment with a PD-1–, PD-L1–, or CTLA-4–targeting agent, or any previous systemic therapy less than 28 days before study registration may be eligible if other criteria are met. Eligible participants will receive induction treatment of nivolumab IV and ipilimumab IV on day 1 every 21 days for up to 4 cycles. Following induction treatment, patients will be randomized to receive either cabozantinib PO on days 1 to 28 (for patients with unconfirmed progressive disease with clinical instability), nivolumab IV on day 1 every 28 days (for patients with immune complete response [CR]), or nivolumab IV on day 1 every 28 days (for patients without CR or disease progression).

The primary outcome measure is OS of patients who achieve CR and progressive disease from the nivolumab and ipilimumab induction phase, assessed up to 5 years. Secondary outcome measures include PFS, CR, objective responses, proportion of patients who discontinue protocol-directed treatment before 1 year from date of study registration, and incidence of AEs. Other outcome measures include estimates of OS by sex, race, and ethnicity. This study plans to enroll approximately 1046 participants throughout the United States and worldwide. For more information, contact the trial sites directly. The NLM identifier is NCT03793166.

The purpose of this open-label, randomized, phase 3 study is to compare the efficacy and safety of belzutifan (Welireg) plus lenvatinib (Lenvima) versus cabozantinib (Cabometyx) in the treatment of patients with advanced clear cell RCC whose disease progressed after receiving previous anti–PD-1/L1 therapy. Patients aged ≥18 years with unresectable locally advanced or metastatic clear cell RCC with measurable disease per RECIST version 1.1; who have a Karnofsky performance status score ≥70%; who have received only 1 previous anti–PD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant, or locally advanced/metastatic RCC; and who have adequate organ function may be eligible if other criteria are met. Eligible participants will be randomized to receive either belzutifan 120 mg PO and lenvatinib 20 mg PO once daily or cabozantinib 60 mg PO once daily.

The primary outcome measures include PFS per RECIST version 1.1 as assessed by blinded independent central review, and OS. Secondary outcome measures include ORR, DOR, the number of participants who have ≥1 AE, and the number of participants who discontinue study treatment due to an AE. The study plans to enroll approximately 708 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04586231.

The purpose of this open-label, randomized, phase 3 trial is to compare the effect of adding cytoreductive nephrectomy to a standard-of-care immunotherapy-based drug combination (nivolumab [Opdivo] alone; pembrolizumab [Keytruda] plus axitinib [Inlyta]; or avelumab [Bavencio]) versus standard-of-care immunotherapy alone in the treatment of patients with metastatic RCC. Patients aged ≥18 years with histologically confirmed RCC with primary tumor in place, as confirmed by computed tomography scans; who have completed any systemic treatment within 90 days before the first dose of treatment medication; and who have a Zubrod performance status of 0 to 1 may be eligible if other criteria are met. Eligible participants will be randomized to receive either immunotherapy alone (nivolumab 240 mg IV every 2 weeks, nivolumab 480 mg IV every 4 weeks; pembrolizumab 200 mg IV every 3 weeks plus axitinib 5 mg PO twice daily; or avelumab 10 mg/kg IV every 2 weeks plus axitinib 5 mg PO twice daily) or immunotherapy plus cytoreductive nephrectomy within 8 weeks of randomization.

The primary outcome measure is OS from date of randomization to date of death due to any cause, assessed up to 7 years. Secondary outcome measures include OS, PFS, objective responses, and change in maximum diameter of primary tumor. This study plans to enroll approximately 364 participants throughout the United States and worldwide. For more information, contact Taj Pereira, MS, at 1-210-614-8808 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Dana Sparks, MAT, at 1-210-614-8808 ext 1004 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04510597