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Stage III Prostate CancerPhase 1NCT03477864

Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer

A Phase 1 study testing Ipilimumab, Stereotactic Body Radiation Therapy (SBRT) and Radical Prostatectomy in people with Stage III Prostate Cancer and Stage IIIA Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects of anti-PD-1 monoclonal antibody REGN2810 (REGN2810) and/or ipilimumab when given together with stereotactic body radiation therapy before surgery in treating participants with prostate cancer that is growing, spreading, or getting worse, and has spread to other places in… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Ipilimumab, Stereotactic Body Radiation Therapy (SBRT) and Radical Prostatectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
24 Dec 2018to 4 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial
  • Have progressive advanced prostate cancer based on at least one of the following criteria:
  • Gleason score of ≥ 7
  • Any PSA
  • TNM clinical stage T3-T4, N1
  • Oligometastatic prostate cancer patients who have not received primary therapy are eligible; (oligometastatic disease is defined as a patient with ≤ 3 metastatic bone lesions on the bone scan or tissue metastasis)
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  • To be scheduled for a Radical Prostatectomy
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Absolute neutrophil count (ANC) ≥ 1000 /mcL within 7 days of treatment initiation
  • Platelets ≥ 150,000 / mcL within 7 days of treatment initiation
  • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L within 7 days of treatment initiation
  • Lymphocytes ≥ 500 / mcL within 7 days of treatment initiation
  • Serum creatinine ≤ 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) ≥ 50 mL/min for subject with creatinine levels > 1.5 X institutional ULN within 7 days of treatment initiation
  • Glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl
  • Serum total bilirubin ≤ 1.5 X ULN within 7 days of treatment initiation
  • Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN within 7 days of treatment initiation
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 X ULN within 7 days of treatment initiation
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants within 7 days of treatment initiation
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as aPTT is within therapeutic range of intended within 7 days of treatment initiation

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment
  • Prior treatment with an agent that blocks PD-1/PD-L1 pathway or other immune modulating agents within fewer than 4 weeks of 4 half-lives
  • Has a diagnosis of immunodeficiency or is receiving any systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to day 1 of trial treatment
  • Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
  • Has had prior treatment with idelalisib
  • Has had prior or current treatment with Androgen Deprivation Therapy
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  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent
  • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Note: Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study
  • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial urothelial cancer, or superficial bladder cancer that has undergone potentially curative therapy
  • Has an active autoimmune disease requiring systemic treatment within the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
  • Has evidence of interstitial lung disease, active, non-infectious pneumonitis
  • Has evidence of significant liver disease
  • Has an active infection requiring systemic therapy; prior to dosing with REGN2810 the subject must be at least 5 half-lives from their last dose of antibiotic
  • Has a history of listeriosis or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Has a contraindication to administration of amoxicillin, ampicillin, ciprofloxacin, erythromycin, gentamycin, penicillin, trimethoprim/sulfamethoxazole, and vancomycin
  • Is expecting to spontaneously conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has contraindication to administration of non-steroidal anti-inflammatory drugs (NSAIDS)
  • Is or has an immediate family member (spouse or children) who is investigational site or staff directly involved with this trial, unless prospective Institutional Review Board (IRB) approval (by chair or designee) is given allowing exception to this criterion for a specific subject

About this study

Official title: R2810-ONC-16XX: A Phase 1 Neoadjuvant Study of Stereotactic Body Radiation Therapy With Systemic REGN2810 and Intraprostatic Ipilimumab, Alone or in Combination, in Patients With Locally Advanced Prostate Cancer Prior to Radical Prostatectomy

This phase I trial studies the side effects of anti-PD-1 monoclonal antibody REGN2810 (REGN2810) and/or ipilimumab when given together with stereotactic body radiation therapy before surgery in treating participants with prostate cancer that is growing, spreading, or getting worse, and has spread to other places in the body, or formed a small number of new tumors in one or two other parts of the body. Monoclonal antibodies, such as anti-PD-1 monoclonal antibody REGN2810 and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving anti-PD-1 monoclonal antibody REGN2810 and ipilimumab with stereotactic body radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety and tolerability for an established effective dose of systemic REGN2810 and intraprostatic ipilimumab with stereotactic body radiation therapy (SBRT) in patients with locally advanced prostate cancer with or without oligometastatic disease.

SECONDARY OBJECTIVES:

  1. To determine overall pathologic response rate after radical prostatectomy. II. To determine prostate-specific antigen (PSA) progression free survival in men treated with REGN2810 and intraprostatic ipilimumab with SBRT.

III. To determine radiographic progression free survival in men treated with REGN2810 and intraprostatic ipilimumab with SBRT.

IV. Acute and chronic adverse events (AEs).

Being tested
Ipilimumab, Stereotactic Body Radiation Therapy (SBRT), Radical Prostatectomy, Anti-PD-1 Monoclonal Antibody REGN2810
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • IpilimumabBiological

    Also called 477202-00-9, 720801, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016

    Given via intraprostatic injection

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

    Undergo SBRT

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo radical prostatectomy

  • Anti-PD-1 Monoclonal Antibody REGN2810Biological

    Given IV

Study groups in NCT03477864
Study groupRoleWhat they receive
Arm A (REGN2810, SBRT, surgery)ExperimentalParticipants receive anti-PD-1 monoclonal antibody REGN2810 IV over 30 minutes on day 1 of week 1 and in week 4, and undergo SBRT for 4 fractions on days 2-5 of week 3. Within 14-21 days, participants undergo radical prostatectomy.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Radical Prostatectomy; Biological: Anti-PD-1 Monoclonal Antibody REGN2810
Arm B (ipilimumab, SBRT, surgery)ExperimentalParticipants receive ipilimumab via intraprostatic injection on day 1 of week 1, and undergo SBRT for 4 fractions on days 2-5 of week 3. Within 14-21 days, participants undergo radical prostatectomy.
Receives: Biological: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Radical Prostatectomy
Arm C (REGN2810, ipilimumab, SBRT, surgery)ExperimentalParticipants receive anti-PD-1 monoclonal antibody REGN2810 as in Arm A and ipilimumab as in Arm B. Participants also undergo SBRT for 4 fractions on days 2-5 of week 3. Within 14-21 days, participants undergo radical prostatectomy.
Receives: Biological: Ipilimumab; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Radical Prostatectomy; Biological: Anti-PD-1 Monoclonal Antibody REGN2810

What is being measured

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

  1. Incidence of adverse events as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria

    Will be assessed by quantifying the toxicities and grades 3 and 4 experienced by subjects who have received REGN2810 + ipilimumab in combination with radiation therapy, including serious adverse events (SAEs) and events of clinical interest (ECIs). Time-to-event continual reassessment (TITE-CRM) design will be used to confirm the safety of the treatments based on toxicities.

    Measured: Up to 70 days

Secondary outcomes (3)

  1. Overall pathologic response rate

    Will be presented with appropriate confidence intervals (95%, unless otherwise specified).

    Measured: Up to 2 years

  2. Prostate specific antigen (PSA) progression free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 2 years

  3. Radiographic progression free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 2 years

Timeline

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

  1. First posted26 Mar 2018
  2. Study start24 Dec 2018
  3. Primary completion4 Nov 2019
  4. Study completion4 Nov 2019

Why it stopped: Study was not accruing

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03477864
Sponsor's protocol ID
17G.508
Other IDs
JT 10817
Status last verified
Apr 2025
First submitted
19 Mar 2018
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ipilimumab, Stereotactic Body Radiation Therapy (SBRT) and Radical Prostatectomy in people with Stage III Prostate Cancer and Stage IIIA Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

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 19 inclusion and 20 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: withdrawn, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of adverse events as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria (time frame: Up to 70 days). 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 NCT03477864.

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 29 Apr 2025.

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