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โ† Trials
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Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

RecruitingPhase 3Ages 18 Years - anyAllArcus Biosciences, Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the most recent regimen (either adjuvant monotherapy or first-line in combination with anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component. * A Karnofsky Performance Status (KPS) score โ‰ฅ 80% * At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy. * Adequate organ and marrow function, โ‰ค 1 week prior to randomization. * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. Exclusion Criteria: * Received prior treatment with a HIF-2ฮฑ inhibitor or cabozantinib. * Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured. * Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade โ‰ฅ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies. * Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \> 150 mmHg systolic or \> 90 mmHg diastolic despite optimal antihypertensive treatment. * History of leptomeningeal disease or spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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What it tests

  • Casdatifan
  • Cabozantinib
  • Placebo
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Where

183 sites
Research Site
Gilbert, United States
Research Site
Goodyear, United States
Research Site
Phoenix, United States
Research Site
Duarte, United States
Research Site
Irvine, United States
Research Site
La Jolla, United States
Research Site
Los Angeles, United States
Research Site
Palo Alto, United States

โ€ฆand 175 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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