A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AVEO Pharmaceuticals, Inc.
Study ID
NCT06064877
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Ficlatuzumab — BIOLOGICAL
    Ficlatuzumab (AV-299) is a humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G1 (IgG1) monoclonal antibody (mAb).
  • Cetuximab — BIOLOGICAL
    Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
  • Placebo — OTHER
    Placebo for this study will be normal saline

Study Details

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.

Key Dates

Start date
Jan 11, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (Investigational Arm: ficlatuzumab plus cetuximab)
    Intravenous (IV) ficlatuzumab dose A on Day 1 (D1) and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
  • Experimental: Arm 2 (Investigational Arm: ficlatuzumab plus cetuximab)
    IV ficlatuzumab dose B on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle
  • Placebo Comparator: Arm 3 (Comparator Arm: placebo plus cetuximab)
    IV placebo (saline, ficlatuzumab-matched) on D1 and D15 of each 28-day cycle IV cetuximab on D1 and D15 of each 28-day cycle

Primary Outcome Measure

To compare the efficacy by overall survival of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) [ Time Frame: From Randomization until death from any cause (Approximately 44 months) ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85212-
The University of Arizona Cancer CenterTucsonArizona85719-
University of California Los AngelesLos AngelesCalifornia90024-
Yale School of Medicine - Smilow Cancer HospitalNew HavenConnecticut06511-
The George Washington UniversityWashington D.C.District of Columbia20052-0042-
AdventHealth Medical Group Oncology & Hematology at OrlandoOrlandoFlorida32804-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30308-
University of Illinois Cancer CenterChicagoIllinois60612-
University of Kansas Cancer CenterWestwoodKansas66205-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
MaineHealth Institute for ResearchSouth PortlandMaine04106-
University of MarylandBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Siteman Cancer Center - Washington UniversitySt LouisMissouri63110-
Northwell Health Cancer InstituteLake SuccessNew York10042-
Manhattan Eye, Ear & Throat HospitalNew YorkNew York10065-
Montefiore Medical CenterThe BronxNew York10461-
University of Cincinnati - UC Health Barrett Cancer CenterCincinnatiOhio45219-
Ohio State University, James Cancer Hospital and Solove Research InstituteColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
MD Anderson Cancer CenterHoustonTexas77030-
Oncology ConsultantsHoustonTexas77030-
VCU Massey Cancer CenterRichmondVirginia23298-
Medical College of Wisconsin - Froedtert Hospital Cancer CenterMilwaukeeWisconsin53202-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZThe University of Arizona Cancer Center· Tucson, AZUniversity of California Los Angeles· Los Angeles, CAYale School of Medicine - Smilow Cancer Hospital· New Haven, CTThe George Washington University· Washington D.C., DCAdventHealth Medical Group Oncology & Hematology at Orlando· Orlando, FL

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