177Lu-PSMA-617 for Kidney Cancer
(LASER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called 177Lu-PSMA-617, a type of radioligand therapy, for individuals with advanced kidney cancer that shows a clear cell component. The main goal is to determine the treatment's effectiveness and safety for patients with this specific cancer type. The treatment is administered in cycles, with regular imaging to monitor progress. Suitable candidates include those with advanced kidney cancer measurable on scans, who have previously tried other cancer treatments like immune therapies and tyrosine kinase inhibitors, and have a PSMA-positive result on a special PET scan. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have received any anti-neoplastic therapy within 14 days before starting the study treatment.
Is there any evidence suggesting that 177Lu-PSMA-617 is likely to be safe for humans?
Research has shown that 177Lu-PSMA-617, a type of radioligand therapy, is generally safe for people. Studies have found that it can be administered in up to six cycles without harming the kidneys, addressing a common concern with such treatments. In other patients, it demonstrated a good overall safety profile, with serious side effects being rare.
The studies also included individuals with kidney problems and found no increase in side effects compared to those with normal kidney function. This suggests that the treatment is well-tolerated even in patients with existing kidney issues.
As this treatment undergoes testing in a mid-stage trial, some evidence of its safety already exists. However, ongoing studies like this one are needed to better understand its safety, especially for treating kidney cancer.12345Why do researchers think this study treatment might be promising for kidney cancer?
Unlike the standard treatments for kidney cancer, which often involve surgery, targeted therapies, or immunotherapy, 177Lu-PSMA-617 introduces a novel approach by using a radioactive compound to target prostate-specific membrane antigen (PSMA) found on cancer cells. This targeted radiation therapy delivers radiation directly to the cancer cells, minimizing damage to surrounding healthy tissue. Researchers are excited about 177Lu-PSMA-617 because it offers a more precise treatment option, potentially leading to better outcomes with fewer side effects compared to more conventional therapies.
What evidence suggests that 177Lu-PSMA-617 might be an effective treatment for kidney cancer?
Studies have shown that 177Lu-PSMA-617 can help treat certain cancers. This treatment uses radioligand therapy, which combines a radioactive substance with a molecule that specifically targets cancer cells. Research indicates that patients with advanced PSMA-positive cancers, such as clear cell renal cell carcinoma (ccRCC), might benefit from this treatment. Specifically, one study found that patients with favorable-risk disease lived longer. In this trial, participants will receive 177Lu-PSMA-617 to evaluate its effectiveness for ccRCC. These promising results suggest that 177Lu-PSMA-617 could be a valuable option for patients with ccRCC.56789
Who Is on the Research Team?
Praful Ravi, MB BCHir, MRCP
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for patients with advanced clear cell renal cell carcinoma (ccRCC) that shows positive for PSMA. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have tried other treatments first.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 177Lu-PSMA-617 for up to 6 cycles, with imaging every 12 weeks
Follow-up
Participants are monitored every 6 months for up to 5 years after treatment discontinuation
What Are the Treatments Tested in This Trial?
Interventions
- 177Lu-PSMA-617
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania