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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT07011719
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Casdatifan — DRUG
    Administered as specified in the treatment arm
  • Cabozantinib — DRUG
    Administered as specified in the treatment arm
  • Placebo — DRUG
    Administered as specified in the treatment arm

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
720 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Experimental Arm)
    Casdatifan and cabozantinib taken orally
  • Placebo Comparator: Arm B (Comparator Arm)
    Placebo and cabozantinib taken orally

Primary Outcome Measure

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 [ Time Frame: up to approximately 33 months ]

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
Research SiteGilbertArizona85234-
Research SiteGoodyearArizona85338-
Research SitePhoenixArizona85054-
Research SiteDuarteCalifornia91010-
Research SiteLa JollaCalifornia92103-
Research SiteLos AngelesCalifornia90095-
Research SiteSacramentoCalifornia95817-
Research SiteSan DiegoCalifornia92103-
Research SiteNew HavenConnecticut06519-
Research SiteJacksonvilleFlorida32224-
Research SiteMiamiFlorida33136-
Research SiteOrlandoFlorida32804-
Research SiteAtlantaGeorgia30318-
Research SiteAtlantaGeorgia30322-
Research SiteNewnanGeorgia30265-
Research SiteZionIllinois60099-
Research SiteIndianapolisIndiana46202-
Research SiteLouisvilleKentucky40207-
Research SiteJeffersonLouisiana70121-
Research SiteBaltimoreMaryland21287-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteOmahaNebraska68198-
Research SiteNew BrunswickNew Jersey08903-
Research SiteBuffaloNew York14263-
Research SiteRochesterNew York14642-
Research SiteChapel HillNorth Carolina27514-
Research SiteClevelandOhio44106-
Research SitePortlandOregon97212-
Research SiteMonroevillePennsylvania15146-
Research SiteCharlestonSouth Carolina29425-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37232-
Research SiteDallasTexas75390-
Research SiteLubbockTexas79430-
Research SiteSalt Lake CityUtah84112-
Research SiteCharlottesvilleVirginia22903-
Research SiteSeattleWashington98109-

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