177Lu-PSMA-617 for Kidney Cancer

(LASER Trial)

Recruiting at 1 trial location

Overseen By Praful Ravi, MB BCHir, MRCP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational agents

Disqualifiers: Untreated brain metastases, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 19

Duration: 36 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Research Team

Praful Ravi, MB BCHir, MRCP

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Experimental: 177Lu-PSMA-617 Experimental Treatment 1 Intervention

Enrolled participants will complete: * Baseline visit --Imaging every 12 weeks, or 2 cycles * Cycles 1 through 2: * Day 1: Predetermined dose of 177Lu-PSMA-617 1x daily * PSMA PET scan before Cycle 3 Day 1 * Cycles 3 through 6: --Day 1: Predetermined dose of 177Lu-PSMA-617 1x daily * End of treatment visit with assessments * Follow Up: every 6 months for up to 5 years * If no radiographic responses of Complete or Partial Response are seen in the first 9 participants enrolled, the trial will terminate. If 1 or more responses are seen in the first 9 participants, the study will enroll an additional 15 participants.

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

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