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

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ClinicalTrials.gov Identifier: NCT03972657
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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.


Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: REGN5678 Drug: Cemiplimab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 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 : June 26, 2019
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Dose Escalation Cohorts
In a series of dose escalation cohorts, patients will receive a 3-week monotherapy lead-in of 3 weekly doses of REGN5678 followed by REGN5678 and cemiplimab in combination.
Drug: REGN5678
Administered at the assigned dose level (DL) by intravenous (IV) infusion once weekly (QW)

Drug: Cemiplimab
Administered at the assigned DL by intravenous (IV) infusion every three weeks (Q3W)
Other Name: REGN2810

Experimental: Dose Expansion Cohorts
In a series of dose expansion cohorts, patients will receive combination therapy of REGN5678 at the recommended phase 2 dose (RP2D) and cemiplimab
Drug: REGN5678
Administered at the assigned dose level (DL) by intravenous (IV) infusion once weekly (QW)

Drug: Cemiplimab
Administered at the assigned DL by intravenous (IV) infusion every three weeks (Q3W)
Other Name: REGN2810




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. Percentage of patients who have achieved an absolute improvement in pain on an 11-point Numeric Pain Rating Scale (NRS) without an overall increase in opiate use [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases. Individual NRS used to rate the intensity of pain using a 0 to 10 numeric rating scale

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

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



Information from the National Library of Medicine

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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) that has progressed within 6 months prior to screening
  • Has received ≥2 lines of approved systemic therapy for mCRPC, including a second -generation hormonal agent
  • Adequate organ and bone marrow function

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, organic brain disease (eg, Parkinson's disease) 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


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, New York
Regeneron Study Site Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trials Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03972657     History of Changes
Other Study ID Numbers: R5678-ONC-1879
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
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://errs.regeneron.com/external

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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
Prostatic Diseases