Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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

Sponsor: Arcus Biosciences, Inc.

NCT ID: NCT07011719

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Casdatifan (drug), Cabozantinib (drug), Placebo (drug)
How long the study runs
Study runs about 63 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at adults with advanced or metastatic clear cell renal cell carcinoma, a type of kidney cancer that has spread or cannot be removed by surgery. It compares a drug called casdatifan taken with cabozantinib against a placebo (a dummy medicine) taken with cabozantinib. The study is run by Arcus Biosciences, Inc.

Who can take part

  • Kidney cancer that is advanced or has spread, is mainly the clear cell type, cannot be removed by surgery, and can be measured on scans
  • Fairly well day-to-day: a Karnofsky Performance Status (a measure of how well you can carry out daily activities) of 80% or more
  • At least one tumour that can be measured by CT (computed tomography) or MRI (magnetic resonance imaging) scans, and it has not been in an area treated with radiotherapy before
  • Organs and bone marrow working well enough, checked within 1 week before joining
  • Women who could become pregnant must have a negative pregnancy blood test

Who may not be able to

  • Previous treatment with a HIF-2α inhibitor (a type of cancer drug) or with cabozantinib
  • Another cancer in the past year, unless it was a cancer that could be fully treated and appears cured
  • Ongoing significant side effects from earlier cancer treatment, or side effects rated Grade 3 or worse (quite severe) regardless of the cause
  • High blood pressure that stays above 150 mmHg (systolic) or 90 mmHg (diastolic) even with treatment
  • A history of leptomeningeal disease (cancer in the fluid around the brain and spinal cord) or spinal cord compression
  • Other rules may also apply — ask the trial team

What taking part involves

  • • Taking casdatifan or a placebo (a dummy medicine) alongside cabozantinib — not stated which is given how, ask the trial team

Time commitment: Not stated — ask the trial team about number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
720
Started
2025-09-08
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic clear cell renal cell carcinoma
  • • Phase3 - 720 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic clear cell renal cell carcinoma

Where?

  • • Cambridge - Research Site
  • • Cottingham - Research Site
  • • Exeter - Research Site
  • • Glasgow - Research Site
  • • +10 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Metastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell Carcinoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ a negative serum pregnancy test

What the study is looking for

  • ✓Unresectable and measurable that has grown locally or that has spread kidney 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 (standard scan measurements), not within a...
  • ✓Adequate organ and marrow function, ≤ 1 week prior to randomization.
  • ✓Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.

Who cannot take part

  • ✗Received prior treatment with a HIF-2α inhibitor or cabozantinib.
  • ✗Other prior cancer active within the previous year except for locally curable cancers that have been apparently...
  • ✗Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \> 150 mmHg systolic or \> 90...
  • ✗History of leptomeningeal disease or spinal cord compression.
  • ✗NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Received prior treatment with a HIF-2α 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 ≥ 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.

Where Is This Study? (14 UK sites)

Research Site

Cambridge, United Kingdom

Recruiting

Research Site

Cottingham, United Kingdom

Recruiting

Research Site

Exeter, United Kingdom

Recruiting

Research Site

Glasgow, United Kingdom

Recruiting

Research Site

Leeds, United Kingdom

Recruiting

Research Site

London, United Kingdom

Recruiting

Research Site

Manchester, United Kingdom

Recruiting

Research Site

Newcastle upon Tyne, United Kingdom

Recruiting

Research Site

Northwood, United Kingdom

Recruiting

Research Site

Preston, United Kingdom

Recruiting

Research Site

Southampton, United Kingdom

Recruiting

Research Site

Sutton, United Kingdom

Recruiting

Research Site

Truro, United Kingdom

Recruiting

Research Site

Whitchurch, United Kingdom

Recruiting

How to Get in Touch

Medical Director

Sponsor contact

CONTACT

+1-510-462-3330 clinicaltrials@arcusbio.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04