A Trial to Find Out if REGN5678 (Nezastomig) 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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03972657
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma (ccRCC)
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN5678 — DRUG
    Administered as per the protocol
  • Cemiplimab — DRUG
    Administered as per the protocol

Study Details

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) 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

Key Dates

Start date
Aug 12, 2019
Status verified
Oct 2025
Primary completion
Nov 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
345 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mCRPC - dose escalation cohort
    REGN5678 with or without cemiplimab
  • Experimental: mCRPC - dose expansion cohort
    REGN5678 with or without cemiplimab
  • Experimental: ccRCC - dose escalation cohort
    REGN5678 with or without cemiplimab
  • Experimental: ccRCC - dose expansion cohort
    REGN5678 with or without cemiplimab

Primary Outcome Measure

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Through study completion, up to 5 years ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo ClinicPhoenixArizona85054-
University of ArizonaTucsonArizona85724-
John Wayne Cancer Institute (JWCI)Santa MonicaCalifornia90404-
Sarah Cannon Research Institute (SCRI)DenverColorado80218-
Yale University HospitalNew HavenConnecticut06510-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Moffitt Cancer Center - McKinley DriveTampaFlorida33612-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55905-
Columbia University - The Trustees of Columbia University in the City of New YorkNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Montefiore Medical CenterNew YorkNew York10461-
NYU Langone Health Perlmutter Cancer CenterNew YorkNew York10016-
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - RochesterRochesterNew York14642-
Oregon Health & Science University (3485 S. Bond)PortlandOregon97239-
Providence Portland Medical CenterPortlandOregon97213-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
Lifespan Cancer InstituteProvidenceRhode Island02903-
MD Anderson Cancer CenterHoustonTexas77030-
Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZMayo Clinic· Phoenix, AZUniversity of Arizona· Tucson, AZJohn Wayne Cancer Institute (JWCI)· Santa Monica, CASarah Cannon Research Institute (SCRI)· Denver, COYale University Hospital· New Haven, CT

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