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Renal Cell CarcinomaPhase 2LASERNCT06964958

177LuPSMA in Renal Cell Carcinoma

A Phase 2 study testing 177Lu-PSMA-617 in people with Renal Cell Carcinoma and Advanced Clear Cell Renal Cell Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
177Lu-PSMA-617
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
31 Jul 2025to 1 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Adequate organ and marrow function as per the below table:
  • System Laboratory Value
  • Hematologic
  • ANC ≥ 1.5×109/L
  • Platelets ≥100×109/L
  • Hemoglobin ≥9g/dL (≥90g/L), independent of transfusions
  • Hepatic
  • Total bilirubin ≤1.5 × ULN OR <2 × ULN if known or suspected Gilbert's syndrome
  • ALT and AST ≤3 × ULN OR ≤5 × ULN if liver metastases present
  • Renal ---eGFR ≥50 mL/min/1.73 m2 (based on Cockcroft-Gault formula OR 24 hour urine collection
  • The effects of 177Lu-PSMA-617 on the developing human fetus are unknown. For this reason and because radiopharmaceutical therapies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Female partners of child-bearing potential should also use highly effective birth control methods throughout the male participant's study treatment and for at least 14 weeks following the last dose of 177Lu-PSMA-617. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and at least 14 weeks following the last dose of 177Lu-PSMA-617.
  • Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)

Who cannot join

  • Prior PSMA-targeted therapy (eg. 177Lu-PSMA-617).
  • Participants who have had radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
  • Participants who have received anti-neoplastic intervention or experimental anti-neoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.
  • Participants who are receiving any other investigational agents.
  • Participants with untreated brain metastases. Participants with treated brain metastases are eligible if follow-up brain imaging at least 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and ongoing corticosteroids are not required. Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
  • Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia. Sensory neuropathy grade ≤2 is acceptable.
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMA-617.
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
  • Concurrent active malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of the investigational regimen. Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are permitted to enroll.
  • NB - participants who are found to have suspected prostate cancer on the basis of PSMA-PET/CT performed for screening (eg. PSMA avid disease in the prostate) are eligible to proceed on study on the basis of clinical judgement by the treating physician. Prostate (or other) biopsy is not required to confirm evidence of prostate cancer, if suspected, prior to proceeding with study therapy as long as the treating physician deems RCC to be a more pressing treatment priority.
  • The participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Females that are pregnant and/or lactating.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: LASER - a Phase 2 Trial of 177Lu-PSMA-617 as Systemic Therapy for Renal Cell Carcinoma

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)

Read the detailed description

The goal of this single-center, phase 2 research study is to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in participants with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC). 177Lu-PSMA-617 aims to deliver targeted radiation to cancer cells, leading to cell death.

The U.S. Food and Drug Administration (FDA) has not approved 177Lu-PSMA-617 as a treatment option for advanced ccRCC, but the study drug is approved for advanced prostate cancer.

The research study procedures include screening for eligibility, in-clinic visits, blood tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA PET) scans.

Participants will receive study treatment for up to 6 cycles, or approximately 252 days, and will be followed every 6 months for up to 5 years after discontinuing treatment.

It is expected that about 24 people will take part in this research study.

Novartis Pharmaceuticals Corporation is supporting this research study by supplying the study drug (177Lu-PSMA-617) and providing funding for the study.

Being tested
177Lu-PSMA-617
Keywords
Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, ccRCC, Prostate-specific membrane antigen, PSMA
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-617Drug

    Also called Pluvicto, Lutetium Lu 177 vipivotide tetraxetan

    A radioligand therapy, single-dose vial, via intravenous (into the vein) infusion per protocol.

Study groups in NCT06964958
Study groupRoleWhat they receive
Experimental: 177Lu-PSMA-617ExperimentalEnrolled 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.
Receives: Drug: 177Lu-PSMA-617

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who experienced complete response (CR) or partial response (PR) during treatment. Tumors will be assessed for response and progression by RECIST version 1.1 by central radiology review.

    Measured: Tumor assessment will be performed every 12 weeks on treatment. Treatment duration is 36 weeks.

Secondary outcomes (3)

  1. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Adverse events will be graded and analyzed using CTCAE v5.

    Measured: Adverse events are collected every study visit until the discontinuation of treatment plus 30 days. Treatment duration is 36 weeks.

  2. Median Disease-free Survival (DFS)

    Disease-free survival (PFS) is defined as the time from the date of treatment initiation to the earlier of progression or death due to any cause. Participants alive without disease are censored at date of last disease evaluation.

    Measured: Tumor assessment will be performed every 12 weeks on treatment. Treatment duration is 36 weeks.

  3. Median Overall Survival (OS)

    OS is Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.

    Measured: Survival follow-up will be every 6 months until 5 years after discontinuing treatment. The treatment duration is 36 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start31 Jul 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06964958
Sponsor's protocol ID
25-216
Acronym
LASER
Status last verified
Feb 2026
First submitted
7 May 2025
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Hazut Krauthammer S, Xie W, LaBrecque N, Arsenault L, Kabarame L, Shah H, Berg S, McGregor B, Serzan M, Xu W, Viswanathan SR, Wei XX, Choueiri TK, Jacene H, Ravi P. LASER: A Phase 2 Trial of 177Lu-PSMA-617 as Systemic Therapy for RCC. J Nucl Med. 2026 Apr 1;67(4):501-505. doi: 10.2967/jnumed.125.271273.

    PubMed 41545068

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-PSMA-617 in people with Renal Cell Carcinoma and Advanced Clear Cell Renal Cell Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Tumor assessment will be performed every 12 weeks on treatment. Treatment duration is 36 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06964958, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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