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Trial record 1 of 1 for:    REGN5678
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Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972657
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

The primary objectives of the study in Dose Escalation are to evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab and in Dose Expansion are to assess efficacy, as measured by objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria, of REGN5678 in combination with cemiplimab.

The secondary objectives of the study in Dose Escalation are to assess efficacy, as measured by ORR per modified PCWG3 criteria, of REGN5678 in combination with cemiplimab and in Dose Expansion are to characterize the safety profile in each expansion cohort and to characterize the PK of REGN5678 in combination with cemiplimab. Secondary objectives in both Dose Escalation and Dose Expansion are to assess efficacy of REGN5678 in combination with cemiplimab, as measured by additional criteria and to assess immunogenicity of REGN5678 in combination with cemiplimab.

Note: All the above primary, secondary objectives will apply to each cohort in the study including those who receive sarilumab and those who do not receive sarilumab.


Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: REGN5678 Drug: Cemiplimab Other: 18F-DCFPyL Drug: Sarilumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : February 13, 2024
Estimated Study Completion Date : February 19, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation Cohorts
In a series of dose escalation cohorts, patients will receive monotherapy lead-in of REGN5678 followed by a combination of REGN5678 and cemiplimab, with or without sarilumab prophylaxis.
 Drug: REGN5678
Administered at the assigned dose level (DL) by intravenous (IV) infusion or subcutaneous (SC) administration

Drug: Cemiplimab
Administered at the assigned DL by intravenous (IV) infusion
Other Name: REGN2810

Other: 18F-DCFPyL
PSMA PET/CT imaging agent to be used at select sites

Drug: Sarilumab
Administered by IV infusion
Experimental: Dose Expansion Cohorts
In a series of dose expansion cohorts, patients will receive REGN5678 followed by combination therapy of REGN5678 (with or without a monotherapy lead-in) at the recommended phase 2 dose (RP2D) and cemiplimab. Expansion cohorts may be performed in cohorts with or without sarilumab.
 Drug: REGN5678
Administered at the assigned dose level (DL) by intravenous (IV) infusion or subcutaneous (SC) administration

Drug: Cemiplimab
Administered at the assigned DL by intravenous (IV) infusion
Other Name: REGN2810

Other: 18F-DCFPyL
PSMA PET/CT imaging agent to be used at select sites

Drug: Sarilumab
Administered by IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  2. Incidence and severity of adverse event of special interests (AESIs) [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  3. Incidence and severity of serious adverse events (SAEs) [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  4. Number of patients with Grade ≥3 laboratory abnormalities [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  5. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: First dose through day 42 of last patient in each dose level ]
    Dose Escalation Phase

  6. Concentration of REGN5678 in serum over time [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  7. Concentration of REGN5678 in combination with cemiplimab in serum over time [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  8. Objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase


Secondary Outcome Measures :
  1. ORR per modified PCWG3 criteria [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase

  2. Incidence and severity of TEAEs [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase

  3. Incidence and severity of AESIs [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase

  4. Incidence and severity of SAEs [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase

  5. Number of patients with grade ≥3 laboratory abnormalities [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase

  6. Concentration of REGN5678 in combination with cemiplimab in serum over time [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase

  7. ORR based upon prostate specific antigen (PSA) response [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases

  8. Percentage of patients with ≥90% decline of PSA [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases

  9. Percentage of patients who have achieved conversion of circulating tumor cell (CTC) count from baseline of ≥5 cells/7.5mL to <5 cells/7.5mL [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases

  10. Presence or absence of antibodies against REGN5678 [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases

  11. Presence or absence of antibodies against cemiplimab [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma

  • Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening

    ≥4 ng/mLthat has progressed within 6 months prior to screening as defined in the protocol

  • Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)

Key Exclusion Criteria:

  • Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
  • Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy
  • Has received prior PSMA-targeting therapy
  • Dose Expansion Only: Has had prior anti-cancer immunotherapy
  • Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  • Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972657


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Arizona
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85704
United States, California
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health Recruiting
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, Oregon
Providence Cancer Institute Franz Clinic Withdrawn
Portland, Oregon, United States, 97213
United States, Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trials Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03972657    
Other Study ID Numbers: R5678-ONC-1879
2022-502131-19-00 ( Other Identifier: EUCT Number )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual patient data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents