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Alpha Therapy

Pembrolizumab + AR Inhibitors for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Scott Tagawa, MD, MS

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy

Patients must have normal organ and marrow function as defined: Absolute neutrophil count >2,000 cells/mm3, Hemoglobin ≥9 g/dL, Platelet count >150,000 x 109/mcL, Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT <3 x ULN in absence of liver metastases; < 5x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria), Serum internalized normalized ratio (INR) OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) must be <1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

Must not have

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

Has an active infection requiring systemic therapy at the time of treatment initiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be collected at the time of visit 1 through 1 year on study

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new prostate cancer treatment that combines two drugs: one that delivers radiation to cancer cells, and one that strengthens the immune system's ability to destroy cancer cells.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has progressed after certain treatments. They must have a good performance status, normal organ function, and agree to contraception during the trial plus 4 months after. Exclusions include other cancers within 2 years, active infections like HIV or hepatitis, recent blood clots or radiotherapy, autoimmune diseases requiring treatment in the last 2 years, current participation in another study drug trial.

What is being tested?

The trial is testing if adding a radioactive drug called 225Ac-J591 to pembrolizumab (an immunotherapy) and an ARPI (androgen receptor pathway inhibitor) can better fight prostate cancer than just pembrolizumab + ARPI. It's a phase I/II study which means they're looking at safety and effectiveness.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fatigue, skin issues, inflammation of organs; radiation-related effects from the radioactive drug; hormonal changes due to ARPIs; plus general risks associated with cancer therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My testosterone levels are below 50 ng/dL, and I am on hormone therapy or have had an orchiectomy.

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My blood counts and kidney, liver, and clotting functions are within normal ranges.

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My prostate cancer is worsening, shown by rising PSA levels, new bone lesions, or growth in scans.

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I am older than 18 years.

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I am fully active or can carry out light work.

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I am a man over 18 with a confirmed prostate cancer diagnosis.

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I agree to use contraception and not donate sperm for 4 months after my last treatment dose.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I am currently being treated for an infection.

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I have not received a live vaccine in the last 30 days.

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I have been treated with specific immune therapy for cancer.

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I had another cancer but was treated successfully and have been cancer-free for 2 years.

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I have a history of myelodysplastic syndrome.

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I have been diagnosed with HIV.

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I have a history of Hepatitis B or active Hepatitis C.

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I haven't had cancer treatment or experimental drugs in the last 4 weeks.

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I have had or currently have lung inflammation treated with steroids.

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I have an active tuberculosis infection.

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I haven't had certain bone-targeted radioisotope treatments recently, but radium-223 over 12 weeks ago is okay.

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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be collected at the time of visit 1 through 1 year on study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be collected at the time of visit 1 through 1 year on study

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be collected at the time of visit 1 through 1 year on study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in composite response rate of pembrolizumab and ARPI with or without 225Ac-J591

Determination of optimal dose of 225Ac-J591 for phase II

Proportion of patients with dose-limiting toxicity (DLT) following treatment with pembrolizumab and 225Ac-J591

Secondary study objectives

Change in biochemical progression-free survival

Change in overall survival following treatment

Change in proportion with 1-year progression-free survival

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + ARPIExperimental Treatment3 Interventions

Patients will receive pembrolizumab (400mg every 6 weeks) and ARPI (standard dose schedule) without 225Ac-J591.

Group II: Pembrolizumab + 225Ac-J591 + ARPIExperimental Treatment4 Interventions

Patients will receive one dose of 225Ac-J591 (single dose, either 65 or 90 Kbq/kg) in combination with pembrolizumab (400mg every 6 weeks) and ARPI (standard dose schedule, examples of ARPI include enzalutamide and apalutamide).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

225Ac-J591

2017

Completed Phase 1

~40

Pembrolizumab

FDA approved

68Ga-PSMA-11

2019