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Trial record 1 of 1 for:    NCT03972657
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A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

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 : March 8, 2024
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab.

The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.

This study is looking at several other research questions, including:

  1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
  2. How REGN5678 alone or in combination with cemiplimab works in the body
  3. How much REGN5678 and/or cemiplimab are present in the blood
  4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer (mCRPC) Clear Cell Renal Cell Carcinoma (ccRCC) Drug: REGN5678 Drug: Cemiplimab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 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 or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : July 3, 2026


Arm Intervention/treatment
Experimental: mCRPC - dose escalation cohort

Participants will receive REGN5678 monotherapy for presumptive recommended phase 2 dose(s) (presumptive RP2D) identification

Note: Dose escalation on monotherapy lead-in of REGN5678 followed by combination therapy of REGN5678 with full dose cemiplimab is no longer actively enrolling new participants. The prophylactic use of sarilumab is no longer in use.

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 IV
Other Names:
  • REGN2810
  • LIBTAYO

Experimental: mCRPC - dose expansion cohort
Participants will receive the REGN5678 presumptive RP2D(s)
Drug: REGN5678
Administered at the assigned dose level (DL) by intravenous (IV) infusion or subcutaneous (SC) administration

Experimental: ccRCC - dose escalation cohort

Participants will receive REGN5678 monotherapy for presumptive RP2D identification

Note: Dose escalation on monotherapy lead-in of REGN5678 followed by combination therapy of REGN5678 with full dose cemiplimab is no longer actively enrolling new participants. The prophylactic use of sarilumab is no longer in use.

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 IV
Other Names:
  • REGN2810
  • LIBTAYO

Experimental: ccRCC - dose expansion cohort
Participants will receive the REGN5678 presumptive RP2D(s)
Drug: REGN5678
Administered at the assigned dose level (DL) by intravenous (IV) infusion or subcutaneous (SC) administration




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 participants 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 participant 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 - mCRPC cohort

  9. ORR per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria [ Time Frame: Through study completion, Up to 5 years ]
    Dose Expansion Phase - ccRCC cohort


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

  2. ORR per RECIST 1.1 criteria [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation Phase - ccRCC cohort

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

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

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

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

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

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

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

  10. Percentage of participants with ≥90% decline of PSA [ Time Frame: Through study completion, Up to 5 years ]
    Dose Escalation and Dose Expansion Phases- mCRPC cohorts

  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

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:

mCRPC cohorts:

  1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.
  2. Prostate specific antigen (PSA) value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.
  3. 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:

    1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
    2. post-177Lu-PSMA-617 radiotherapy expansion cohort only. Must have received at least 2 doses of 177Lu-PSMA-617.

ccRCC cohorts:

  1. Men and women with histologically or cytologically confirmed RCC with a clear-cell component.
  2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
  3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-programmed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor

Key Exclusion Criteria:

  1. 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, as described in the protocol
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
  3. Has received prior PSMA-targeting therapy with the exception of approved radiopharmaceutical therapy (eg. 177Lu-PSMA-617) in mCRPC patients
  4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
  5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as describe in the protocol
  6. 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
  7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  8. 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
  9. 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, Arizona
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
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
Montefiore Medical Center Recruiting
New York, New York, United States, 10461
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
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03972657    
Other Study ID Numbers: R5678-ONC-1879
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024
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
Carcinoma, Renal Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Urologic Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents