Informations générales (source: ClinicalTrials.gov)
Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment
Interventional
Phase 2
European Organisation for Research and Treatment of Cancer - EORTC (Voir sur ClinicalTrials)
avril 2026
janvier 2029
30 juillet 2026
Background This study is for adults with advanced kidney cancer that has spread to other
parts of the body and has continued to progress despite treatment with immunotherapy and
targeted therapy. Unfortunately, treatment options at this stage of the disease are
limited. The existing treatments' ability to work against cancer has not been fully
looked into.
Rationale The goal of this study is to examine if a new drug treatment called
177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active
ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced
prostate cancer since December 2022, can also help treat advanced kidney cancer.
The drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a
specific protein on cancer cells. This protein, known as prostate-specific membrane
antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the
treatment begins, participants will undergo a PET (positron-emission tomography) scan to
check if their kidney cancer cells express high levels of PSMA. This scan uses a small
amount of radioactive material (in the form of 177Lutetium) to visualize the presence of
PSMA on the cancer cells. Only participants who test positive for PSMA can take part in
the study. In this approach, PSMA serves two purposes. First, it helps assess whether the
cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach
to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly
to the tumour, which helps kill cancer cells while minimizing damage to normal cells.
This type of treatment is known as a radiopharmaceutical.
Objective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney
cancer and to assess its safety. Throughout the study, participants will undergo several
imaging assessments to check their disease and response to treatment.
The study also includes the collection of tissue samples. Together with the information
collected from the imaging assessments, this will allow further research into markers
that may lead to earlier detection of tumour spread or help identify individuals who may
benefit more from treatment with 177Lu-PSMA-617.
Treatment All participants will receive 177Lu-PSMA-617 through an intravenous injection
at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments
will be administered approximately every six weeks, for a maximum of six times.
Blood tests are done before and during treatment to check the participant's health and to
detect any early side effects from the treatment. Different types of scans are performed
before, during, and after 177Lu-PSMA-617 administration to check how well the treatment
is working. After treatment ends, follow-up visits will be scheduled every six weeks
during the first year. In the second year, your doctor will decide how often you need to
come in for visits. These appointments are important for monitoring how the body
continues to respond to the treatment. The entire study period will last approximately
two years from the time of study entry.
Participants
The study will include approximately 56 participants who will be tested for PSMA
expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To
qualify, participants must:
- Be diagnosed with advanced kidney cancer previously treated with immunotherapy and
targeted therapy.
- Test positive for PSMA on a PET scan.
- Be generally healthy and able to perform daily activities.
- Be at least 18 years of age.
Benefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating
advanced prostate cancer and could be a promising new treatment possibility for kidney
cancer, although this has not yet been shown. By joining this study, participants will
contribute to valuable research to better understand kidney cancer and improve treatment
options for future patients. Participating in this study offers a chance to try a new
treatment, which might help people with advanced kidney cancer live longer and prevent
the disease from getting worse, especially for those who have limited treatment options
left after immunotherapy and targeted therapy.
With all new treatments, there are possible risks and side effects associated with them.
Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth,
loss of appetite, and changes in blood cells. While not all side effects are known yet,
the study team will carefully follow participants for any side effects during and after
treatment. It is important to understand that while the study is being done to provide
new information, there are still some questions on the treatment's safety and how well it
will work.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Laurence ALBIGES | 30/07/2026 21:20:04 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Francois Baclesse (CLCC) - 14076 - Caen - France | Florence Joly | Contact (sur clinicalTrials) | |||
| Gustave Roussy - 94805 - Villejuif - France | Laurence Albiges | Contact (sur clinicalTrials) | |||
Critères
Tous
PRE-SCREENING
- Histologically proven ccRCC. Sarcomatoid component is allowed.
- Adult patients ≥18 years old.
- Has progressed on or after ≥1-line prior systemic therapy approved in the metastatic
setting. Prior treatment must include an anti-programmed death-1 (receptor)
[PD-1]/programmed death-ligand 1 (PD-L1) therapy +/- ipilimumab and a VEGFR-TKI.
- Written pre-screening informed consent according to ICH/GCP and local regulations.
SCREENING
- Patients with at least one PSMA-positive metastatic lesion, and no exclusionary
PSMA-negative lesions, with positive lesions defined as those with a maximum
standardized uptake value (SUVmax) greater than the mean standardized uptake value
(SUVmean) of liver background.
- Measurable disease by RECIST 1.1 criteria.
- Patients with adequate blood tests (Absolute neutrophil count > 1.5 x 109/L,
haemoglobin > 9.0 g/dL, platelet count > 100,000/µL, estimated glomerular filtration
rate (GFR) ≥ 40 ml/min by CKD-EPI formula, total bilirubin ≤ 1.5 x ULN. Aspartate
aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN in patients
with liver metastases).
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1.
- Women of childbearing potential (WOCBP) must have a negative serum (or urine)
pregnancy test within 72 hours prior to registration. A positive urine pregnancy
test result must immediately be confirmed using a serum test. A pregnancy test is to
be reported within 7 days prior to the first dose of the study treatment.
Note: women of childbearing potential are defined as premenopausal females capable of
becoming pregnant (i.e., females who have had any evidence of menses in the past 12
months, with the exception of those who had prior hysterectomy). However, women who have
been amenorrhoeic for 12 or more months are still considered to be of childbearing
potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low
body weight, ovarian suppression, or other reasons.
- Patients of childbearing / reproductive potential should use adequate birth control
measures during the study treatment period and for at least 14 weeks after the last
dose of treatment. A highly effective method of birth control is defined as a method
which results in a low failure rate (i.e., less than 1% per year) when used
consistently and correctly. Such methods include:
- Combined (oestrogen and progestogen containing) hormonal contraception
associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence (the reliability of sexual abstinence needs to be evaluated
in relation to the duration of the clinical trial and the preferred and usual
lifestyle of the patient)
- Female subjects who are breast feeding should discontinue nursing prior to the
first dose of study treatment and until 3 months after the last study
treatment.
- Before patient's enrolment, written informed consent must be given according to
ICH/GCP, and national/local regulations. This includes consent to comply to
recommended radioprotection precautions during study.
Exclusion Criteria:
- Patient with RCC in a single kidney.
- Patients with PSMA-negative lesions (defined as PSMA uptake equal to or lower than
that of liver parenchyma) in any lymph node with a short axis of at least 15 mm, in
any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any
metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short
axis. Patients with any PSMA-negative metastatic lesion meeting these criteria are
ineligible.
- Other malignancy that is expected to interfere with the treatment or results of this
study, such as prostate cancer.
- Patient with active uncontrolled or symptomatic central nervous system (CNS
metastases).
Note: patients treated previously with radiotherapy and/or surgery resulting in
controlled/asymptomatic CNS disease are allowed.
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those
conditions should be assessed and discussed with the patient before the enrolment in
the in the trial.
- Known contraindication to imaging tracer or any product of contrast media.