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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (14 UK sites)
Research Site
Cambridge, United Kingdom
Research Site
Cottingham, United Kingdom
Research Site
Exeter, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Research Site
Northwood, United Kingdom
Research Site
Preston, United Kingdom
Research Site
Southampton, United Kingdom
Research Site
Sutton, United Kingdom
Research Site
Truro, United Kingdom
Research Site
Whitchurch, United Kingdom
How to Get in Touch
Medical Director
Sponsor contactCONTACT
