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Radiopharmaceutical treatment of advanced kidney cancer
EU CTIS ID: 2024-517899-38-00
What this study is testing
The primary objective is to evaluate the activity of 177Lu-PSMA-617 through Objective Response in metastatic ccRCC patients progressing on or after treatment with one ICI, and one VEGFR-TKI, either in combination or in sequence.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven ccRCC. Sarcomatoid component is allowed.
- Written pre-screening informed consent according to ICH/GCP and local regulations.
- 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 antiprogrammed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy +/- ipilimumab and a VEGFR-TKI.
- Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with maximum standardized uptake values (SUVmax) greater than mean standardized uptake values (SUVmean) of liver background.
- Measurable disease by RECIST 1.1 criteria
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 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 were 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).
- Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed.
See the full eligibility criteria
- Histologically proven ccRCC. Sarcomatoid component is allowed.
- Written pre-screening informed consent according to ICH/GCP and local regulations.
- 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 antiprogrammed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy +/- ipilimumab and a VEGFR-TKI.
- Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with maximum standardized uptake values (SUVmax) greater than mean standardized uptake values (SUVmean) of liver background.
- Measurable disease by RECIST 1.1 criteria
- Patients with adequate blood tests (Absolute neutrophil count > 1.5 x 109/L, Hemoglobin > 9.0 g/dL, Platelet count > 100,000/μL, estimated glomerular filtration rate (GFR) ≥ 40 ml/min by CKDEPI 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.
- Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- 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 were 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).
- Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.