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A study of PF-08634404, ipilimumab, and axitinib in adults with advanced or metastatic kidney cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the safety and effectiveness of the drug PF-08634404 when used alone or in combination with other medicines for adults with Renal Cell Carcinoma. This disease is a type of kidney cancer that is either locally advanced, meaning it has grown into nearby tissues, or metastatic, which means the cancer has spread to other parts of the body.

Participants may receive PF-08634404 through an intravenous method, which involves delivering the medicine directly into a vein. Depending on the assigned group, the treatment may also include ipilimumab, given by intravenous use, or axitinib, which is taken as an oral medication by mouth. The study involves testing these different combinations to see how well they work against the cancer and to identify the best amount of medicine to use.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in cohort a

    The treatment involves the administration of pf-08634404, which is a medicine given through an intravenous infusion, meaning it is delivered directly into a vein.

    This stage focuses on using pf-08634404 as a single therapy to monitor how the body responds and to identify any side effects.

  2. Step 2

    Participation in cohort b

    The treatment consists of pf-08634404 given through an intravenous infusion combined with ipilimumab.

    ipilimumab is an anticancer medicine administered through an intravenous infusion into a vein.

  3. Step 3

    Participation in cohort c

    The treatment consists of pf-08634404 given through an intravenous infusion combined with axitinib.

    axitinib is an anticancer medicine taken as an oral medication, which means it is swallowed by mouth.

Who can join the trial?

9 criteria

  • You must be 18 years of age or older at the time of the initial screening.
  • You must have locally advanced kidney cancer, which means the cancer is advanced but cannot be removed with surgery or treated with radiation, or metastatic renal cell carcinoma, which is a type of kidney cancer that has spread to other parts of the body.
  • Your diagnosis must be confirmed by histology or cytology, which means a doctor has looked at your cells under a microscope to confirm the cancer type.
  • You must have at least one measurable lesion, which is a tumor or area of cancer that is large enough for doctors to see and track using medical imaging.
  • The lesion must be untreated, meaning it has not been targeted by previous treatments.
  • You must have adequate hematologic, hepatic, cardiac, and renal function, which means your blood counts, liver, heart, and kidneys must be working well enough to participate safely.
  • You must not have received any prior systemic therapy for kidney cancer, which refers to treatments like drugs that travel through the entire body. However, you may have received immunotherapy (a treatment that helps your immune system fight cancer) after surgery if it was more than 12 months ago.
  • You must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and how much the cancer affects your physical functioning.
  • You may fall into any IMDC risk category, which is a classification system used to group patients based on certain health factors to predict how the disease might progress.

Who cannot join the trial?

11 criteria

  • Having known active brain lesions, which means areas of cancer growth in the brain, including cancer that has spread to the brain lining (leptomeningeal metastasis), the brainstem, the protective layers around the brain (meninges), or the spinal cord, or any pressure on these areas.
  • Having any acute, chronic, or symptomatic infections, which refers to any current or long-term illnesses caused by germs like bacteria or viruses that are causing symptoms.
  • A history of immunodeficiency, which is a condition where your body's immune system—the system that fights off germs—is not working correctly.
  • Having a high risk of haemorrhage (severe bleeding) or a fistula (an abnormal tunnel or connection that forms between two body parts).
  • Having a history of another malignancy, which is another word for cancer, within the last 3 years.
  • A history of allogeneic organ transplantation (receiving an organ from another person) or allogeneic hematopoietic stem cell transplantation (receiving blood-forming stem cells from another person).
  • Having active autoimmune diseases, which are conditions where the immune system mistakenly attacks the body's own healthy cells, that required systemic treatment (medicine that travels through the whole body) within the last 2 years.
  • Having uncontrolled cardiac (heart) issues or other comorbidities (other medical conditions occurring at the same time) within 6 months before the first dose.
  • Having had major surgery or severe trauma (serious physical injury) within 4 weeks before the first dose, or having a major surgery planned during the study.
  • A history of severe bleeding tendency or coagulation dysfunction, which means your blood has trouble clotting or stopping a bleed.
  • A history of oesophageal varices (swollen veins in the tube connecting the throat to the stomach), severe ulcers (sores in the lining of the stomach or intestines), gastrointestinal perforation (a hole in the stomach or intestines), abdominal fistula (an abnormal connection in the belly area), gastrointestinal obstruction (a blockage in the digestive tract), or an intra-abdominal abscess (a collection of pus inside the belly).
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Investigated drugs

  • Ipilimumab

    is a type of immunotherapy that helps the body's own immune system recognize and attack cancer cells.

  • Axitinib

    is a targeted therapy medication that works by blocking certain proteins that help cancer cells grow and spread.

  • PF-08634404

    is an experimental drug being studied to see how well it can fight cancer cells, both on its own and when used together with other cancer treatments.

What is already known about the treatment

  • Ipilimumab

    This medication is an immunotherapy drug administered through an intravenous infusion into the bloodstream. It is currently an established treatment used primarily for certain types of advanced cancers, such as melanoma. It works by blocking a specific protein on immune cells that acts like a brake, thereby allowing the body's own immune system to recognize and attack cancer cells more effectively.

  • Axitinib

    This is a targeted therapy medication that is taken orally by mouth. It is widely used in medical practice to treat advanced kidney cancer by preventing the growth of new blood vessels that tumors need to survive. At a molecular level, it functions by blocking specific enzymes that signal the body to create these blood vessels, effectively starving the tumor of its nutrient supply.

  • PF-08634404

    This substance is an experimental drug provided as a concentrate for intravenous infusion. It is currently being studied in clinical trials to determine its effectiveness and safety for treating advanced or metastatic kidney cancer. This drug works by targeting and blocking specific molecular pathways that help cancer cells grow and spread throughout the body.

Investigated diseases

Advanced or metastatic renal cell carcinoma - This is a type of cancer that starts in the cells of the kidney. The disease occurs when abnormal cells grow uncontrollably within the kidney tissue. In the advanced stage, the cancer has grown significantly within the kidney. When it becomes metastatic, the cancer cells spread from the kidney to other parts of the body, such as the lungs or bones. This progression involves the movement of malignant cells through the blood or lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523524-53-00Protocol codeC6461008Estimated enrolment224 patientsSponsorPfizer Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).