Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Casdatifan for Metastatic Clear Cell Renal Cell Carcinoma

The purpose of the study is to measure the progression-free survival (PFS) of casdatifan versus dummy treatment (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 this drug alone or first-line in combination with anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.

Official registry: https://clinicaltrials.gov/study/NCT07011719 · Arcus Biosciences, Inc. · enrollment listed as 720

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Casdatifan, Cabozantinib, or Placebo. The registry lists allocation as randomized. The purpose of the study is to measure the progression-free survival (PFS) of casdatifan versus dummy treatment (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 this drug alone or first-line in combination with anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.

They plan to enroll about 720 people at 188 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Interventions: Casdatifan, Cabozantinib, Placebo

Primary outcome (registry wording): Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component
  • A Karnofsky Performance Status (KPS) score ≥ 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, ≤ 1 week prior to randomization
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test

Public study contact (from the registry)

Medical Director

+1-510-462-3330

clinicaltrials@arcusbio.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

188 listed

+ 145 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07011719 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07011719?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07011719?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary