A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07276399
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

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

Interventions

  • Amivantamab — BIOLOGICAL
    Amivantamab will be administered.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered.
  • Carboplatin — DRUG
    Carboplatin will be administered.
  • 5-Flurouracil — DRUG
    5-Flurouracil will be administered for over 4-day infusion period.
  • Cisplatin — DRUG
    Cisplatin will be administered.

Study Details

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Key Dates

Start date
Dec 3, 2025
Status verified
Jun 2026
Primary completion
Jun 18, 2029
Completion
Jun 18, 2029

Study Design

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

Arms

  • Experimental: Arm A: Pembrolizumab, Amivantamab, Carboplatin
    Participants will receive pembrolizumab, amivantamab and carboplatin.
  • Active Comparator: Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
    Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 3 years 7 months ]

Central Contacts

Locations (41)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research CenterChandlerArizona85224-
Providence St Jude Medical CenterFullertonCalifornia92835-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Valkyrie Clinical Trials MurrietaMurrietaCalifornia92562-
Stanford University Medical CenterStanfordCalifornia94304-
Hartford HospitalHartfordConnecticut06102-
Yale Cancer CenterNew HavenConnecticut06510-
Florida Cancer Specialists SouthFort MyersFlorida33901-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
AdventHealth Medical Group Oncology and Hematology at OrlandoOrlandoFlorida32804-
Florida Cancer Specialists North RegionSt. PetersburgFlorida33701-4553-
Florida Cancer Specialists EastWest Palm BeachFlorida33401-3406-
Emory UniversityAtlantaGeorgia30308-
Central Georgia Cancer CareMaconGeorgia31210-
Rush University Medical Center Rush University Cancer Center ChicagoChicagoIllinois60607-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
Cancer Care Specialists of Central IllinoisO'FallonIllinois62269-
University of Kentucky Medical CenterLexingtonKentucky40536-
University of Marlyand BaltimoreBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Karmanos Cancer InstituteDetroitMichigan48201 2013-
Washington University School Of MedicineSt LouisMissouri63108-
NHO Revive Research Institute, LLCLincolnNebraska68506-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineolaNew York11501-
Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Bronx Veterans Affairs Medical CenterThe BronxNew York10468-
Montefiore Medical CenterThe BronxNew York10461-
Carolina Cancer Research CenterWilsonNorth Carolina27893-
University of CincinnatiCincinnatiOhio45219-
Ohio State UniversityColumbusOhio43210-
Oregon Health And Science UniversityPortlandOregon97239-
Tennessee Cancer SpecialistsKnoxvilleTennessee37909-
Vanderbilt University Medical CenterNashvilleTennessee37232-
UT Southwestern Medical CenterDallasTexas75390-
Texas Oncology - San AntonioFredericksburgTexas78624-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology-Central SouthWacoTexas76712-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22908-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer and Research Center· Chandler, AZProvidence St Jude Medical Center· Fullerton, CAValkyrie Clinical Trials· Los Angeles, CAValkyrie Clinical Trials Murrieta· Murrieta, CAStanford University Medical Center· Stanford, CAHartford Hospital· Hartford, CT

Related Studies