Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT04590963
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Monalizumab — DRUG
    Participants will receive IV infusion of monalizumab as stated in arm description.
  • Cetuximab — DRUG
    Participants will receive IV infusion of cetuximab as stated in arm description.
  • Placebo — OTHER
    Participants will receive IV infusion of placebo as stated in arm description.

Study Details

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer

Key Dates

Start date
Oct 2, 2020
Status verified
May 2026
Primary completion
May 11, 2022
Completion
Sep 24, 2026

Study Design

Enrollment
370 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
    Participants will receive intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 every one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
  • Active Comparator: Placebo Q2W + Cetuximab 400 mg/m^2
    Participants will receieve IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Primary Outcome Measure

Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set [ Time Frame: Baseline (-28 to -1) through 17.5 months (maximum observed duration) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteChicagoIllinois60612-
Research SiteWestwoodKansas66205-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteLas VegasNevada89169-
Research SiteNew YorkNew York10029-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteColumbusOhio43210-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19111-
Research SitePittsburghPennsylvania15232-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77090-

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