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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects Achieving Undetectable PSA at 6 months after Combination Treatment
Secondary outcome measures
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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

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
~5620
REGN2810
2017
Completed Phase 1
~80
Degarelix
2002
Completed Phase 3
~3600
Leuprolide Acetate
2002
Completed Phase 3
~1890

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,827 Total Patients Enrolled
3 Trials studying Prostate Cancer
236 Patients Enrolled for Prostate Cancer
Mark SteinLead Sponsor
3 Previous Clinical Trials
129 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Mark N. Stein, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
Mark Stein 2019. "REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03951831.
All > Prostate Cancer New York
~3 spots leftby Apr 2025
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