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Study of Lutetium-177-PSMA treatment for patients with advanced clear cell kidney cancer who had progression after first or second line therapy

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 study focuses on treating patients with Clear Cell Renal Cell Carcinoma, which is a type of kidney cancer. The research evaluates a new treatment approach using Lutetium-PSMA-617, which is a radioactive medication that specifically targets cancer cells. This treatment is being studied in patients whose cancer has spread to other parts of the body and has continued to grow despite previous treatments.

The treatment involves receiving intravenous infusions of Lutetium-PSMA-617 (also known as Pluvicto). The medication is given through a vein, and patients may receive up to six treatments over a period of 36 weeks. Each treatment session delivers a carefully measured dose of the radioactive medication that attaches to specific proteins found on cancer cells.

The purpose of this study is to determine how well Lutetium-PSMA-617 works in treating advanced kidney cancer that has not responded well to other treatments. During the study, doctors will monitor how the cancer responds to the treatment through regular imaging scans. The treatment's safety will also be carefully monitored throughout the study period to track any side effects that patients may experience.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be confirmed through blood tests to check for adequate levels of blood cells, kidney function, and liver function

    A scan will be performed to identify PSMA-positive metastatic lesions in your body

    Your overall physical condition will be assessed using the ECOG performance status scale, which must be 0 or 1

  2. Step 2

    Treatment administration

    You will receive Pluvicto through an intravenous infusion

    The medication contains lutetium (177Lu) vipivotide tetraxetan, a radioactive substance that targets specific cancer cells

    The solution will be administered at a concentration of 1,000 MBq/mL

  3. Step 3

    Monitoring and assessment

    Your response to treatment will be evaluated through regular imaging scans

    The medical team will monitor for any side effects using standardized criteria

    Your cancer's response will be classified as either complete response, partial response, or no response

    Regular assessments will continue to track the progress of your disease and overall health status

  4. Step 4

    Follow-up period

    The study will continue monitoring your health status after treatment completion

    Regular check-ups will assess your long-term response to the treatment

    The total duration of the study extends until January 2029

Who can join the trial?

8 criteria

  • Must have confirmed clear cell renal cell carcinoma (a type of kidney cancer) through tissue examination. Sarcomatoid features (an aggressive form of the cancer) are acceptable.
  • Must be at least 18 years old.
  • Must have previously received and shown disease progression after treatment with: - At least one immunotherapy treatment targeting PD-1/PD-L1 (medications that help your immune system fight cancer) - At least one VEGFR-TKI (medications that block blood vessel growth in tumors)
  • Must have at least one cancer lesion that is PSMA-positive (shows up on a special type of scan) with specific uptake values higher than liver background.
  • Must have tumors that can be measured using standard criteria (RECIST 1.1).
  • Must have adequate blood test results, including: - White blood cell count above 1.5 x 109/L - Hemoglobin above 9.0 g/dL - Platelet count above 100,000/μL - Kidney function (GFR) of 40 ml/min or higher - Liver function tests within acceptable ranges
  • Must have good physical function, with an ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance).
  • Must be able to understand and sign an informed consent form.

Who cannot join the trial?

14 criteria

  • Prior history of other cancers within 3 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Known active brain metastases (cancer that has spread to the brain) or brain involvement
  • Severe heart conditions including:
    • Heart failure with symptoms
    • Unstable angina (chest pain)
    • Recent heart attack within 6 months
    • Irregular heart rhythm requiring treatment
    • Active, uncontrolled infections requiring treatment
    • Known positive test for HIV, active hepatitis B, or active hepatitis C
    • Pregnant or breastfeeding women
    • Any serious medical condition that could interfere with study participation
    • Unable to understand or sign informed consent document
    • Previous treatment with radioligand therapy (targeted radiation treatment)
    • Known allergic reactions to study medications or similar compounds
    • Participation in another clinical trial within 30 days before starting this study
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Investigated drugs

177Lu-PSMA-617 (Lutetium PSMA-617) is a targeted radioactive medication used to treat certain types of cancer. It works by attaching to specific proteins (PSMA) found on cancer cells and delivering radiation directly to these cells. This medication is given through an intravenous infusion and is typically used when other treatments have not been successful. The treatment combines a radioactive substance (Lutetium-177) with a molecule that specifically targets cancer cells, allowing for more precise treatment while trying to minimize damage to healthy tissue.

What is already known about the treatment

177Lu-PSMA-617 – A radioactive therapeutic agent administered intravenously that specifically targets PSMA (Prostate-Specific Membrane Antigen) expressing cells. This radiopharmaceutical consists of a targeting molecule (PSMA-617) combined with the radioactive isotope Lutetium-177, which delivers targeted radiation therapy to cancer cells. Currently used in clinical trials for treating clear cell renal cell carcinoma (ccRCC) in patients who have progressed after previous treatments, particularly following immunotherapy and targeted therapy. The medication works by binding to PSMA receptors on cancer cells and delivering localized radiation that damages the DNA of these cells, leading to their death. It belongs to the class of targeted radiopharmaceutical therapies, representing an innovative approach in precision medicine for cancer treatment.

Investigated diseases

Clear Cell Renal Cell Carcinoma - A type of kidney cancer that begins in the cells lining small tubes in the kidneys. It gets its name from the clear appearance of cancer cells under a microscope due to their high lipid content. The disease typically starts in one kidney and can grow into a tumor that may spread to nearby tissues and organs. Clear cell renal cell carcinoma is the most common form of kidney cancer in adults. The condition usually develops slowly over time, starting as a small growth in the kidney tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517899-38-00Protocol codeEORTC-2361-GUCGEstimated enrolment58 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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