Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07011719

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Led by Arcus Biosciences, Inc. · Updated on 2026-05-14

720

Participants Needed

97

Research Sites

272 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

CONDITIONS

Official Title

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
  • Karnofsky Performance Status (KPS) score of 80% or higher.
  • At least one target lesion measurable by CT or MRI per RECIST 1.1, not in a prior radiation field.
  • Adequate organ and marrow function within 1 week before randomization.
  • Women of childbearing potential must have a negative serum pregnancy test.
Not Eligible

You will not qualify if you...

  • Prior treatment with a HIF-2 alpha inhibitor or cabozantinib.
  • Another active malignancy within the past year except for locally curable cancers that appear cured.
  • Ongoing significant toxicities from prior anticancer treatments or Grade 3 or higher toxicities regardless of cause.
  • Uncontrolled or poorly controlled hypertension (blood pressure over 150/90 mmHg) despite treatment.
  • History of leptomeningeal disease or spinal cord compression.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 97 locations

1

Research Site

Gilbert, Arizona, United States, 85234

Actively Recruiting

2

Research Site

Goodyear, Arizona, United States, 85338

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3

Research Site

Phoenix, Arizona, United States, 85054

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4

Research Site

Duarte, California, United States, 91010

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5

Research Site

La Jolla, California, United States, 92103

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6

Research Site

Los Angeles, California, United States, 90095

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7

Research Site

Sacramento, California, United States, 95817

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8

Research Site

San Diego, California, United States, 92103

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9

Research Site

New Haven, Connecticut, United States, 06519

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10

Research Site

Jacksonville, Florida, United States, 32224

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11

Research Site

Miami, Florida, United States, 33136

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12

Research Site

Orlando, Florida, United States, 32804

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13

Research Site

Atlanta, Georgia, United States, 30318

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14

Research Site

Atlanta, Georgia, United States, 30322

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15

Research Site

Newnan, Georgia, United States, 30265

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16

Research Site

Zion, Illinois, United States, 60099

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17

Research Site

Indianapolis, Indiana, United States, 46202

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18

Research Site

Louisville, Kentucky, United States, 40207

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19

Research Site

Jefferson, Louisiana, United States, 70121

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20

Research Site

Baltimore, Maryland, United States, 21287

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21

Research Site

Boston, Massachusetts, United States, 02114

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22

Research Site

Boston, Massachusetts, United States, 02215

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23

Research Site

Rochester, Minnesota, United States, 55905

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24

Research Site

St Louis, Missouri, United States, 63110

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25

Research Site

Omaha, Nebraska, United States, 68198

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26

Research Site

New Brunswick, New Jersey, United States, 08903

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27

Research Site

Buffalo, New York, United States, 14263

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28

Research Site

Rochester, New York, United States, 14642

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29

Research Site

Chapel Hill, North Carolina, United States, 27514

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30

Research Site

Cleveland, Ohio, United States, 44106

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31

Research Site

Portland, Oregon, United States, 97212

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32

Research Site

Monroeville, Pennsylvania, United States, 15146

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33

Research Site

Charleston, South Carolina, United States, 29425

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34

Research Site

Nashville, Tennessee, United States, 37203

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35

Research Site

Nashville, Tennessee, United States, 37232

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36

Research Site

Dallas, Texas, United States, 75390

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37

Research Site

Lubbock, Texas, United States, 79430

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38

Research Site

Salt Lake City, Utah, United States, 84112

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39

Research Site

Charlottesville, Virginia, United States, 22903

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40

Research Site

Seattle, Washington, United States, 98109

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41

Research Site

Chermside, Australia

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42

Research Site

Hobart, Australia

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43

Research Site

Kurralta Park, Australia

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44

Research Site

Subiaco, Australia

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45

Research Site

Montreal, Canada

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46

Research Site

Toronto, Canada

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47

Research Site

Prague, Czechia

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48

Research Site

Angers, France

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49

Research Site

Brest, France

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50

Research Site

Montpellier, France

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51

Research Site

Paris, France

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52

Research Site

Poitiers, France

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53

Research Site

Rennes, France

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54

Research Site

Strasbourg, France

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55

Research Site

Villejuif, France

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56

Research Site

Berlin, Germany

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57

Research Site

Dresden, Germany

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58

Research Site

Frankfurt, Germany

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59

Research Site

Halle, Germany

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60

Research Site

Rostock, Germany

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61

Research Site

Terni, Italy

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62

Research Site

Nijmegen, Netherlands

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63

Research Site

Rotterdam, Netherlands

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64

Research Site

Zwolle, Netherlands

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65

Research Site

Auckland, New Zealand

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66

Research Site

Christchurch, New Zealand

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67

Research Site

Krakow, Poland

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68

Research Site

Otwock, Poland

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69

Research Site

Poznan, Poland

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70

Research Site

Rzeszów, Poland

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71

Research Site

Skorzewo, Poland

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72

Research Site

Tomaszów Mazowiecki, Poland

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73

Research Site

Craiova, Romania

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74

Research Site

Suceava, Romania

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75

Research Site

Timișoara, Romania

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76

Research Site

Busan, South Korea

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77

Research Site

Daejeon, South Korea

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78

Research Site

Goyang, South Korea

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79

Research Site

Seongnam, South Korea

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80

Research Site

Seoul, South Korea

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81

Research Site

Suwon, South Korea

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82

Research Site

Barcelona, Spain

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83

Research Site

Córdoba, Spain

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84

Research Site

Madrid, Spain

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85

Research Site

Santander, Spain

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86

Research Site

Seville, Spain

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87

Research Site

Vigo, Spain

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88

Research Site

Cambridge, United Kingdom

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89

Research Site

Exeter, United Kingdom

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90

Research Site

Glasgow, United Kingdom

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91

Research Site

Leeds, United Kingdom

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92

Research Site

London, United Kingdom

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93

Research Site

Manchester, United Kingdom

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94

Research Site

Preston, United Kingdom

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95

Research Site

Southampton, United Kingdom

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96

Research Site

Sutton, United Kingdom

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97

Research Site

Truro, United Kingdom

Actively Recruiting

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Research Team

M

Medical Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma | DecenTrialz