Efficacy of [177Lu]Lu-PSMA-617 in Patients with Metastatic Clear-cell Renal Cell Carcinoma: The Multicentre, Single-arm, Phase 2 RENALUT Trial.
Emmanuel Seront, Mehdi Bsilat, Karolien Goffin...
https://pubmed.ncbi.nlm.nih.gov/41073165Actively Recruiting
Phase 2
Age: 18Years - 100Years
All Genders
ID06783348
Phase II Trial Evaluating 177Lutetium-PSMA-617 Treatment in Adults With Metastatic Clear Cell Renal Cell Carcinoma Progressing After Immunotherapy and Targeted Therapy
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-06-04
48
Participants Needed
2
Research Sites
48 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
A
Advanced Accelerator Applications
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called 177Lu-PSMA-617 for adults with advanced kidney cancer that has spread and continued to progress despite immunotherapy and targeted therapy. This treatment targets a specific protein called PSMA found on kidney cancer cells. Participants must test positive for PSMA on a PET scan to join the study, which aims to assess the treatment's usefulness and safety in this setting. All participants will receive 177Lu-PSMA-617 through intravenous injections every six weeks, with a standard dose of 7.4 GBq, for up to six doses. If participants show partial response or stable disease after four doses, they may receive two additional doses. Blood tests and various scans will be done before, during, and after treatment to monitor health, side effects, and how well the treatment works. Participants will have follow-up visits every six weeks during the first year, with visit frequency determined by their doctor in the second year. The study will last about two years from enrollment. Researchers will collect tissue samples and imaging data to explore markers that may help detect tumor spread earlier or identify who may benefit most from the treatment. The main outcome measured is the objective response to treatment nine months after the last patient joins.
CONDITIONS
Brief Title
Radiopharmaceutical Treatment of Advanced Kidney Cancer
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed clear cell renal cell carcinoma (ccRCC), including sarcomatoid component
- Age 18 years or older
- Progression after at least one prior systemic therapy including immune checkpoint inhibitor and VEGFR-tyrosine kinase inhibitor
- Presence of at least one PSMA-positive metastatic lesion on PET scan
- Measurable disease by RECIST 1.1 criteria
- Adequate blood counts and organ function
- ECOG performance status 0 or 1
- Negative pregnancy test for women of childbearing potential prior to treatment
- Use of effective birth control during treatment and for 14 weeks after last dose
- Ability to provide written informed consent and comply with study procedures
You will not qualify if you...
- Single kidney with renal cell carcinoma
- Presence of PSMA-negative metastatic lesions of significant size as defined by study criteria
- Other active malignancy expected to interfere with study treatment or results
- Active, uncontrolled, or symptomatic central nervous system metastases
- Psychological, social, or geographic conditions impacting compliance
- Known contraindications to imaging tracer or contrast agents
- Breastfeeding females who do not discontinue nursing prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 36 weeks depending on response and tolerance
Participants receive 177Lu-PSMA-617 by intravenous infusion every 6 weeks (±1 week) for up to 4 doses. Participants with partial response or stable disease after 4 doses may receive up to 2 additional doses.
Up to 6 infusion visits approximately every 6 weeks
Follow-up
Duration - Up to 42 months after treatment initiation
Participants are monitored for safety, disease control, and survival outcomes after treatment completion.
Periodic visits as scheduled for imaging and assessments
Trial Site Locations
Total: 2 locations
1
Centre Francois Baclesse (CLCC)
Caen, France, 14076
Actively Recruiting
2
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
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Research Team
E
EORTC
E
EORTC, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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