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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
CHU Helora	La Louviere	Belgium
Hopital Beaujon	Clichy	France
Centre Francois Baclesse	Caen	France
Cfbmucnjb Umuhjmjlxqzkgo Ssybzfxfk	Woluwe-Saint-Lambert	Belgium
Hqrjbdau Dl Li Sjfkn Ccpd I Sabc Prg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	15.09.2025
France	Recruiting	15.09.2025
Spain	Not yet recruiting	15.09.2025

Trial locations

Investigated drugs:

Lutetium (177Lu) Vipivotide Tetraxetan

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.

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 ID:

2024-517899-38-00

Protocol code:

EORTC-2361-GUCG

NCT ID:

NCT06783348

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?