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Study of Axitinib and Pembrolizumab for Patients with Advanced or Metastatic Papillary Renal Cell Carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of kidney cancer known as papillary renal cell carcinoma (PRCC), which can be locally advanced or has spread to other parts of the body. The study is investigating the effectiveness of two medications: axitinib and pembrolizumab. Pembrolizumab is also known by other names such as MK-3475 and is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. Axitinib is taken orally, which means it is consumed by mouth.

The purpose of this study is to evaluate how well the combination of axitinib and pembrolizumab works compared to axitinib alone in treating patients with this type of kidney cancer. Participants in the study will receive either the combination of both medications or axitinib by itself. The study will monitor the response to the treatment over a period of time to see which approach is more effective. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will have regular visits to the clinic for treatment and monitoring. This will include receiving the medication, having blood tests, and undergoing other necessary procedures to ensure their safety and to track the progress of the treatment. The study aims to provide valuable information on the best treatment options for patients with papillary renal cell carcinoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have signed and dated an approved informed consent form. This confirms understanding and agreement to participate in the study.

    The patient must meet specific criteria, including being 18 years or older, having a confirmed diagnosis of locally advanced or metastatic papillary renal cell carcinoma (PRCC), and having no prior systemic treatment for renal cancer.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the patient meets all inclusion criteria. This includes evaluating the patient's performance status, confirming adequate bone marrow, liver, and kidney function, and ensuring no significant proteinuria is present.

  3. Step 3

    Treatment phase

    The treatment phase involves administering two medications: pembrolizumab and axitinib.

    Pembrolizumab is given as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

    Axitinib is taken orally. The dosage and frequency are also specified in the study protocol.

    The treatment aims to evaluate the effectiveness of the combination of these medications in treating PRCC.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's response to treatment is closely monitored. This includes regular visits for assessments and laboratory tests.

    The primary goal is to measure the objective response rate (ORR), which indicates how well the cancer responds to the treatment.

    Secondary goals include evaluating the duration of response, progression-free survival, overall survival, and safety of the treatment.

  5. Step 5

    End of study

    The study is estimated to conclude by May 31, 2027. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Must be at least 18 years old on the day of signing the consent form.
  • Must be willing and able to attend scheduled visits, follow treatment plans, and undergo tests and procedures required by the study.
  • If capable of having children, must agree to use effective birth control or avoid heterosexual activity during the study and for a specified time after the last dose of treatment.
  • Must sign and date an approved consent form before any study-specific procedures or assessments.
  • Must have a type of kidney cancer called **type 2 papillary renal cell carcinoma (PRCC)** that is either spread to other parts of the body or cannot be removed by surgery. This must be confirmed by a central review of tissue samples.
  • Must not have received any previous treatment for kidney cancer, including chemotherapy, immunotherapy, or other drugs.
  • Must have at least one area of cancer that can be measured according to specific guidelines.
  • Must have a good general health status, as measured by a specific scale called the **Eastern Cooperative Oncology Group (ECOG) Performance Status**, with a score of 0 or 1.
  • If previously received radiation therapy, must have stopped it at least 3 weeks before starting the study treatment and have recovered from any side effects.
  • Must have adequate functioning of bone marrow, liver, and kidneys, as shown by specific blood test results.
  • Must not have significant levels of protein in the urine, as confirmed by a urine test.
  • Must have medical or health insurance coverage.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have already received treatment for their cancer.
  • Patients who have serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
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Investigated drugs

  • Axitinib

    is a medication used to treat certain types of kidney cancer. In this clinical trial, it is being tested to see how well it works for patients with advanced or metastatic papillary renal cell carcinoma. Axitinib works by blocking certain proteins that help cancer cells grow, which may slow down or stop the growth of the cancer.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system fight cancer. It is being tested in combination with axitinib to see if it improves treatment outcomes for patients with advanced or metastatic papillary renal cell carcinoma. Pembrolizumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy the cancer.

What is already known about the treatment

  • Axitinib

    Axitinib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic papillary renal cell carcinoma (PRCC). It is approved for use in certain types of kidney cancer and is being evaluated in combination with other medications. Axitinib works by inhibiting specific proteins called tyrosine kinases, which are involved in the growth of cancer cells. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

  • Pembrolizumab

    Pembrolizumab is administered through intravenous infusion and is being investigated in clinical trials for its potential to treat locally advanced or metastatic papillary renal cell carcinoma (PRCC) when used in combination with axitinib. It is already approved for use in various cancers, including melanoma and lung cancer. Pembrolizumab functions by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) – This is a type of kidney cancer that originates in the renal tubules and is characterized by the formation of small, finger-like projections. It is classified as either type 1 or type 2, with type 2 being more aggressive. In its locally advanced stage, the cancer has spread beyond the kidney to nearby tissues or lymph nodes. When metastatic, it has spread to distant parts of the body, such as the lungs or bones. The disease progresses as cancer cells continue to grow and invade other tissues, potentially leading to various symptoms depending on the organs affected. The progression can vary significantly among individuals, influenced by factors such as the cancer's genetic characteristics and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513986-38-00Protocol codeET21-023Estimated enrolment72 patientsSponsorCentre Leon Berard

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