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New treatment option for Metastatic Clear Cell Renal Cell Carcinoma
Official title Radiopharmaceutical Treatment of Advanced Kidney Cancer
ClinicalTrials.gov ID: NCT06783348
What this study is testing
What is 177Lu-PSMA-617?
177Lu-PSMA-617 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic clear cell renal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- Written pre-screening informed consent according to ICH/GCP and local regulations. SCREENING
You likely can't join if
- 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...
- 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...
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule...
- Known contraindication to imaging tracer or any product of contrast media.
See the full eligibility criteria
- 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 +/-...
- 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...
- 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...
- 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...
- 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...
- 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 people 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.
- 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...
- 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...
- Known contraindication to imaging tracer or any product of contrast media.
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.