177LuPSMA in Renal Cell Carcinoma (NCT06964958) | Clinical Trial Compass
Active — Not RecruitingPhase 2
177LuPSMA in Renal Cell Carcinoma
United States24 participantsStarted 2025-07-31
Plain-language summary
This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC).
The name of the study drug involved in this research study is:
-177Lu-PSMA-617 (a type of radioligand therapy)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed advanced or metastatic renal cell carcinoma with a clear cell component. Patients with sarcomatoid histology are eligible.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
* Age ≥18 years.
* Prior receipt of at least one immune checkpoint inhibitor and at least one tyrosine kinase inhibitor in the neoadjuvant, adjuvant or metastatic settings. Prior treatment with Ra-223 is permitted providing that the last dose was ≥90 days prior to study entry.
* Presence of ≥1 PSMA-avid lesion (with uptake \> liver) on baseline/screening 68Ga-PSMA-11 PSMA-PET/CT (within 28 days of planned C1D1), and the absence of any measurable PSMA-negative lesions (i.e. nodal, soft tissue or visceral lesions \>1cm) on baseline/screening 68Ga-PSMA-11 PSMA-PET. All patients considered for the study should have their PSMA-PET imaging reviewed in a multidisciplinary meeting with Medical Oncology and Nuclear Medicine to confirm eligibility.
* ECOG performance status ≤2.
* Adequate organ and marrow function as per the below table:
* System Laboratory Value
* Hematologic
* ANC ≥ 1.5×109…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Tumor assessment will be performed every 12 weeks on treatment. Treatment duration is 36 weeks.