A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Merus B.V.
Study ID
NCT06496178
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Petosemtamab — DRUG
    MCLA-158
  • Investigator's Choice — DRUG
    Cetuximab
  • Investigator's Choice — DRUG
    Methotrexate
  • Investigator's Choice — DRUG
    Docetaxel

Study Details

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.

Key Dates

Start date
Jun 25, 2024
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Mar 31, 2029

Study Design

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

Arms

  • Experimental: MCLA-158
  • Active Comparator: Investigator's Choice

Primary Outcome Measure

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

Central Contacts

Locations (61)

FacilityCityStateZIPSite coordinators
Site 160MobileAlabama36608-
Site 102PrescottArizona86301-
Site 125ScottsdaleArizona85054-
Site 82DuarteCalifornia91010-
Site 25La JollaCalifornia92037-
Site 173OrangeCalifornia92868-
Site 28Palo AltoCalifornia94304-
Site 127SacramentoCalifornia95817-
Site 46San FranciscoCalifornia94158-
Site 130Lone TreeColorado80124-
Site 104Washington D.C.District of Columbia20010-
Site 12Fort MyersFlorida33901-
Site 123JacksonvilleFlorida32224-
Site 9OrlandoFlorida32827-
Site 138TampaFlorida33612-
Site 187AtlantaGeorgia30322-
Site 207AtlantaGeorgia30341-
Site 152ChicagoIllinois60607-
Site 213ChicagoIllinois60611-
Site 68ChicagoIllinois60637-
Site 31IndianapolisIndiana46202-
Site 8LouisvilleKentucky40202-
Site 40Baton RougeLouisiana70809-
Site 100New OrleansLouisiana70121-
Site 153ColumbiaMaryland21044-
Site 77BostonMassachusetts02215-
Site 103Ann ArborMichigan48109-
Site 5DetroitMichigan48201-
Site 49Maple GroveMinnesota55369-
Site 124RochesterMinnesota55905-
Site 18St LouisMissouri63110-
Site 86HackensackNew Jersey07601-
Site 15AlbuquerqueNew Mexico87131-
Site 24New YorkNew York10029-
Site 214The BronxNew York10461-
Site 98Chapel HillNorth Carolina27514-
Site 122DurhamNorth Carolina27710-
Site 23CincinnatiOhio45219-
Site 87ClevelandOhio44195-
Site 32ColumbusOhio43210-
Site 26PortlandOregon97213-
Site 151BensalemPennsylvania19020-
Site 158PhiladelphiaPennsylvania19107-
Site 159PhiladelphiaPennsylvania19114-
Site 50CharlestonSouth Carolina29425-
Site 60ChattanoogaTennessee37404-
Site 54MemphisTennessee38103-
Site 59NashvilleTennessee37203-
Site 67NashvilleTennessee37232-
Site 55DenisonTexas75020-
Site 34El PasoTexas79915-
Site 51HoustonTexas77030-
Site 7HoustonTexas77030-
Site 94PearlandTexas77584-
Site 4Salt Lake CityUtah84112-
Site 10BlacksburgVirginia24060-
Site 22CharlottesvilleVirginia22908-
Site 156WinchesterVirginia22601-
Site 163SeattleWashington98109-
Site 6SpokaneWashington99202-
Site 216MadisonWisconsin53705-

Find similar trials in Mobile, AL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Site 160· Mobile, ALSite 102· Prescott, AZSite 125· Scottsdale, AZSite 82· Duarte, CASite 25· La Jolla, CASite 173· Orange, CA

Related Studies