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NCT03972657 | RECRUITING | Metastatic Castration-resistant Prostate Cancer (mCRPC)

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
Sponsor:

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

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Clear Cell Renal Cell Carcinoma (ccRCC)

Intervention/treatment

REGN5678

Cemiplimab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 345 participants
Masking : NONE
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 : 2019-08-12
Estimated Primary Completion Date : 2025-08-01
Estimated Study Completion Date : 2026-07-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
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

Location Details

NCT03972657

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

RECRUITING

United States, Arizona

University of Arizona

Tucson, Arizona, United States, 85724

RECRUITING

United States, California

John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States, 90404

RECRUITING

United States, Colorado

Sarah Cannon Research Institute (SCRI)

Denver, Colorado, United States, 80218

RECRUITING

United States, Connecticut

Yale University Hospital

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Florida

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, United States, 33612

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, New York

NYU Langone Health Perlmutter Cancer Center

New York, New York, United States, 10016-4744

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

RECRUITING

United States, New York

Columbia University - The Trustees of Columbia University in the City of New York

New York, New York, United States, 10032

RECRUITING

United States, New York

Montefiore Medical Center

New York, New York, United States, 10461

WITHDRAWN

United States, Oregon

Providence Portland Medical Center

Portland, Oregon, United States, 97213

RECRUITING

United States, Oregon

Oregon Health & Science University (3485 S. Bond)

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Rhode Island

Lifespan Cancer Institute

Providence, Rhode Island, United States, 02903

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

Emily Couric Clinical Cancer Center

Charlottesville, Virginia, United States, 22908