Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02383212
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer
  • Advanced Malignancies

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
  • Hypofractionated radiotherapy — RADIATION
  • Cyclophosphamide — DRUG
  • Docetaxel — DRUG
  • Carboplatin — DRUG
  • GM-CSF — DRUG
  • Paclitaxel — DRUG
  • Pemetrexed — DRUG

Study Details

This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.

Key Dates

Start date
Feb 2, 2015
Status verified
Jan 2020
Primary completion
Nov 18, 2019
Completion
Nov 18, 2019

Study Design

Enrollment
398 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Cohort
    Cemiplimab will be administered alone
  • Experimental: Dual Combination Cohorts
    Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy Doses of cemiplimab will be administered in combination with Cyclophosphamide Doses of cemiplimab will be administered in combination with Docetaxel
  • Experimental: Triple Combination Cohorts
    Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF Doses of cemiplimab will be administered in combination with Carboplatin plus Paclitaxel Doses of cemiplimab will be administered in combination with Carboplatin plus Pemetrexed Doses of cemiplimab will be administered in combination with Carboplatin plus Docetaxel
  • Experimental: Quadruple Combination Cohorts
    Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Change from baseline to week 48 ]

Locations (40)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona--
Western Regional Medical CenterGoodyearArizona--
Mayo ClinicPhoenixArizona--
University of Arizona Cancer CenterTucsonArizona--
City of Hope National Medical CenterDuarteCalifornia--
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia--
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Stanford UniversityStanfordCalifornia--
Sarah Cannon Research Institute at HealthONEDenverColorado--
Norwalk HospitalNorwalkConnecticut--
Georgetown University Medical CenterWashington D.C.District of Columbia--
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida--
Winship Cancer Institute, Emory UniversityAtlantaGeorgia--
University of ChicagoChicagoIllinois--
Indiana UniversityIndianapolisIndiana--
University of Kansas Cancer CenterFairwayKansas--
Dana Farber Cancer InstituteBostonMassachusetts--
Barbara Ann Karmanos Cancer CenterDetroitMichigan--
Washington University School of Medicine Siteman Cancer CenterSt LouisMissouri--
Nebraska Methodist HospitalOmahaNebraska--
Hackensack University Medical CenterHackensackNew Jersey--
Cancer Institute of New JerseyNew BrunswickNew Jersey--
Columbia University Medical CenterNew YorkNew York--
Laura & Isaac Perlmutter Cancer CenterNew YorkNew York--
Mount Sinai Medical CenterNew YorkNew York--
Weill Cornell Medical CollegeNew YorkNew York--
Duke Cancer InstituteDurhamNorth Carolina--
University Hospitals Case Medical CenterClevelandOhio--
Stephenson Cancer CenterOklahoma CityOklahoma--
Providence Portland Medical CenterPortlandOregon--
Penn State Milton S Hershey Medical CenterHersheyPennsylvania--
University of Pittsburgh Medical Center ShadysidePittsburghPennsylvania15232-
Miriam HospitalProvidenceRhode Island--
Sarah Cannon Research InstituteNashvilleTennessee--
Vanderbilt University Medical CenterNashvilleTennessee--
Mary Crowley Cancer Research Center - Medical CityDallasTexas--
Baylor College of MedicineHoustonTexas--
The University of Texas MD Anderson Cancer CenterHoustonTexas--
START South Texas Accelerated Research TherapeuticsSan AntonioTexas--
Northwest Medical SpecialtiesTacomaWashington--

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZWestern Regional Medical Center· Goodyear, AZMayo Clinic· Phoenix, AZUniversity of Arizona Cancer Center· Tucson, AZCity of Hope National Medical Center· Duarte, CARonald Reagan UCLA Medical Center· Los Angeles, CA

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