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Hormone Therapy

Chemoimmunotherapy + Hormone Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Mark N. Stein, MD

Research Sponsored by Mark Stein

Eligibility Criteria Checklist

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

Must have

Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Have metastatic disease that is either measurable or evaluable (non-measurable).

Must not have

Had a solid organ or hematologic transplant.

Peripheral neuropathy must be ≤ grade 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for prostate cancer that combines hormone therapy, chemotherapy, and immunotherapy. The goal is to see if the treatment is safe and effective.

Who is the study for?

Men over 18 with newly metastatic, hormone-sensitive prostate cancer who haven't had certain treatments like androgen deprivation therapy or chemotherapy for prostate cancer in the last 6 months. They should have a life expectancy over a year, good organ function, no severe allergies to trial drugs, and agree to use contraception.

What is being tested?

The trial is testing REGN2810 combined with hormonal therapy (Degarelix or Leuprolide Acetate) and Docetaxel chemotherapy. The goal is to see if this mix can make prostate-specific antigen levels undetectable after six months of treatment.

What are the potential side effects?

Possible side effects include immune system reactions that could affect organs, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, allergic reactions related to infusion of the drug, and issues from hormonal changes.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has spread and can be measured or observed.

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I haven't had chemotherapy or immunotherapy before surgery.

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I haven't used hormone therapy for my condition in the last 6 months.

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My kidneys are functioning well enough for treatment.

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My cancer can be measured or seen on scans, and a sample can be taken.

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I have not had both testicles surgically removed.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had an organ or bone marrow transplant.

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My nerve damage symptoms are mild or not present.

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I have not taken steroids or immunosuppressants in the last 7 days.

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I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

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I am currently being treated for an infection.

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I have a history of lung disease or inflammation not caused by infection.

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I have previously received immunotherapy treatments.

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I have received chemotherapy for prostate cancer.

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I have not had radiation in the last 2 weeks.

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I have both hepatitis B and C infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Subjects Achieving Undetectable PSA at 6 months after Combination Treatment

Secondary study objectives

Radiographic Response

Time to Development of Castrate Resistance

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ADT Followed by ChemoimmunotherapyExperimental Treatment4 Interventions

REGN2810 followed by chemoimmunotherapy: Initiate degarelix 240mg SC once, followed by leuprolide acetate 22.5mg SC every 3 months. Week 4 start cemiplimab (REGN 2810) 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease. Week 10 start docetaxel 75 mg/m2 every 21 days for up to 6 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

REGN2810

2017

Completed Phase 1

~80