177Lu-PSMA-617 for Kidney Cancer

(LASER Trial)

Not yet recruiting at 1 trial location
PR
Overseen ByPraful Ravi, MB BCHir, MRCP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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?

PR

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

My kidney cancer is advanced or has spread, and tests confirm it.
My scans show at least one lesion that is PSMA-positive and no PSMA-negative lesions.
Ability to understand and the willingness to sign a written informed consent document.
See 5 more

Exclusion Criteria

I have previously received PSMA-targeted therapy.
Participants who are receiving any other investigational agents.
I have recovered from previous cancer treatment side effects, except for hair loss or mild nerve damage.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive 177Lu-PSMA-617 for up to 6 cycles, with imaging every 12 weeks

36 weeks
In-clinic visits, imaging every 12 weeks

Follow-up

Participants are monitored every 6 months for up to 5 years after treatment discontinuation

5 years
Follow-up every 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • 177Lu-PSMA-617
Trial Overview The study is testing the efficacy and safety of a radioligand therapy called 177Lu-PSMA-617 in treating ccRCC. Radioligand therapy targets cancer cells with radiation delivered directly to the tumor through a molecule that binds to PSMA.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental: 177Lu-PSMA-617Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Novartis

Industry Sponsor

Trials
1,646
Recruited
2,778,000+
Vasant Narasimhan profile image

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 profile image

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Citations

Impact of extended [177Lu] Lu-PSMA-617 therapy on ...The study included 110 patients who received ≥ 4 cycles of [177Lu] Lu-PSMA − 617 therapy. Whole-body static and abdominal SPECT-CT imaging was ...
Efficacy of [177Lu]Lu-PSMA-617 in Patients with Metastatic ...Updated results after median follow-up of 67.7 mo showed a potential OS benefit in IMDC favourable-risk disease (hazard ratio 0.94, 95% CI 0.65– ...
Comparative Safety and Efficacy of 177Lu-PSMA-617 and ...No significant differences were observed in bone marrow suppression, liver or renal function, PSA responses, or survival.
177Lu-PSMA-617 Trial May Be Efficacious in Advanced ...Success with the 177Lu-PSMA-617 radioligand therapy would be transformative for the clear cell renal cell carcinoma treatment landscape.
NCT06964958 | LASER - a Phase 2 Trial of 177Lu-PSMA- ...This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear ...
Renal and Multiorgan Safety of 177 Lu-PSMA-617 in ...These data indicate that 44.4 GBq of 177Lu-PSMA-617 can safely be administered cumulatively over 6 cycles without inducing renal toxicity.
Renal and Multiorgan Safety of 177Lu-PSMA-617 in Patients ...Lu-PSMA-617 had a good overall safety profile, and low renal radiotoxicity was not a safety concern. Cumulative absorbed doses in at-risk organs ...
ASCO GU 2025: Safety Profile of Lutetium-177 in Patients ...The investigators sought to determine whether patients with impaired renal function who received Lu-177 experienced a higher incidence of adverse events.
Final overall survival and safety analyses of the phase III ...Final overall survival and safety analyses of the phase III PSMAfore trial of [177Lu]Lu-PSMA-617 versus change of androgen receptor pathway ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security