177Lu-PSMA-617 + Pembrolizumab for Prostate Cancer

Overseen By Patricia Li

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of California, San Francisco

Must be taking: LHRH analogues

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Untreated brain metastases, Autoimmune disease, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 22

Duration: 2 years

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase Ib trial studies the dose and schedule of 177Lu-PSMA-617 and pembrolizumab in treating persons with castration-resistant prostate cancer that has spread to other places in the body. 177Lu-PSMA-617 carries a radioactive component which attached to the prostate specific membrane antigen (PSMA) receptor found on tumor cells. Its radiation component destroys the tumor cell. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving 177Lu-PSMA-617 and pembrolizumab may work better at treating prostate cancer.

Research Team

Rahul Aggarwal, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for patients with metastatic castration-resistant prostate cancer who've progressed after treatment with androgen signaling inhibitors. They must have good blood counts, organ function, agree to contraception, and not have untreated brain metastases or certain other health conditions.

Inclusion Criteria

If you have had a procedure called vasectomy, which prevents pregnancy, you will still be considered capable of having children for this study.

Patients must provide consent to comply to recommended radioprotection precautions during study

Hemoglobin > 9.0 g/dL

Exclusion Criteria

I had radiotherapy over 2 weeks ago, with no ongoing side effects and didn't need steroids.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lutetium Lu 177-PSMA-617 and pembrolizumab according to one of three dosing schedules. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years).

2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 weeks

1 visit (in-person)

Extension

Participants who achieve stable disease or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.

1 year

Treatment Details

Interventions

• Lutetium Lu 177-PSMA-617
• Pembrolizumab

Trial Overview The study tests a combination of 177Lu-PSMA-617 (a radioactive drug targeting prostate cancer cells) and pembrolizumab (an immunotherapy). It aims to find the best dose and schedule for treating advanced prostate cancer by enhancing the body's immune response against tumors.

Participant Groups

Group I: Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (lutetium Lu 177-PSMA-617, pembrolizumab) Experimental Treatment 2 Interventions

Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.

Group II: Part A: Dosing Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab) Experimental Treatment 2 Interventions

Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.

Group III: Part A: Dosing Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab) Experimental Treatment 2 Interventions

Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.

Group IV: Part A: Dosing Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab) Experimental Treatment 2 Interventions

Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+