NCT03477864|WithdrawnPhase 1DMCFDA Drug

Study Stopped

Study was not accruing

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

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

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

17G.508

Secondary identifiers

JT 10817

OTHER · JeffTrial Number

Study Type

interventional

Actual enrollment (reported)

Locations

0 countries

Sites

N/A

Timeline

Study Start

December 24, 2018

Actual (reported)

Primary Completion

November 4, 2019

Actual (reported)

Study Completion

November 4, 2019

Actual (reported)

Brief 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 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: November 4, 2019
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 19, 2018
Actual (reported)
First Posted
March 26, 2018
Actual (reported)
Study Start
December 24, 2018
Actual (reported)
Primary Completion
November 4, 2019
Actual (reported)
Study Completion
November 4, 2019
Actual (reported)

Last Updated: April 29, 2025
Status Verified: April 2025
Last Update Submitted: April 28, 2025

Conditions

Stage III Prostate Cancer Stage IIIA Prostate Cancer Stage IIIB Prostate Cancer Stage IIIC Prostate Cancer Stage IV Prostate Cancer

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
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
+4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Arm A (REGN2810, SBRT, surgery)

Arm B (ipilimumab, SBRT, surgery)

Arm C (REGN2810, ipilimumab, SBRT, surgery)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Arm A (REGN2810, SBRT, surgery)

Arm B (ipilimumab, SBRT, surgery)

Arm C (REGN2810, ipilimumab, SBRT, surgery)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record