Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03580694
Phase
PHASE1
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • REGN4659 — DRUG
    REGN4659 will be administered by intravenous (IV) infusion.
  • Cemiplimab — DRUG
    Cemiplimab will be administered by intravenous (IV) infusion.

Study Details

The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.

Key Dates

Start date
Jun 27, 2018
Status verified
Mar 2020
Primary completion
Dec 4, 2019
Completion
Dec 4, 2019

Study Design

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

Arms

  • Experimental: Cemiplimab Monotherapy
    In a single dose escalation cohort, participants will receive cemiplimab alone.
  • Experimental: Combination Therapy
    Dose Escalation cohorts: In 3 dose escalation cohorts, participants will receive a lead-in dose of REGN4659 followed by REGN4659 and cemiplimab in combination. In 4 dose escalation cohorts, participants will receive REGN4659 with cemiplimab in combination. Dose Expansion cohorts: In dose expansion cohorts, participants will receive combination regimens of REGN4659 and cemiplimab.

Primary Outcome Measure

Rate of dose limiting toxicities (DLTs) during the dose escalation phase [ Time Frame: Up to week 126 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Regeneron Investigational SiteChicagoIllinois60637-
Regeneron Investigational SiteGrand RapidsMichigan49546-
Regeneron Investigational SiteCharlotteNorth Carolina28204-
Regeneron Investigational SiteOklahoma CityOklahoma73104-
Regeneron Investigational SiteNashvilleTennessee37203-
Regeneron Investigational SiteSan AntonioTexas78229-

Find similar trials in Chicago, IL

By research site
Regeneron Investigational Site· Chicago, ILRegeneron Investigational Site· Grand Rapids, MIRegeneron Investigational Site· Charlotte, NCRegeneron Investigational Site· Oklahoma City, OKRegeneron Investigational Site· Nashville, TNRegeneron Investigational Site· San Antonio, TX

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