A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Merus B.V.
Study ID
NCT06525220
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Petosemtamab — DRUG
    MCLA-158
  • Pembrolizumab — DRUG
    Humanized Antibody

Study Details

This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.

Key Dates

Start date
Sep 25, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: Petosemtamab + Pembrolizumab
    Combination Therapy
  • Active Comparator: Pembrolizumab
    Monotherapy

Primary Outcome Measure

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

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
Site 164MobileAlabama36607-
Site 36La JollaCalifornia92037-
Site 27Los AngelesCalifornia90033-
Site 16Palo AltoCalifornia94304-
Site 19NewarkDelaware19713-
Site 108Washington D.C.District of Columbia20010-
Site 14Fort MyersFlorida33901-
Site 48OrlandoFlorida32804-
Site 8OrlandoFlorida32827-
Site 21St. PetersburgFlorida33705-
Site 20West Palm BeachFlorida33401-
Site 171AtlantaGeorgia30322-
Site 197ChicagoIllinois60611-
Site 50ChicagoIllinois60637-
Site 2LouisvilleKentucky40202-
Site 162Baton RougeLouisiana70809-
Site 155MinneapolisMinnesota55417-
Site 168St LouisMissouri63108-
Site 94HackensackNew Jersey07601-
Site 6AlbuquerqueNew Mexico87131-
Site 113DurhamNorth Carolina27710-
Site 118Winston-SalemNorth Carolina27157-
Site 191ClevelandOhio44195-
Site 153PhiladelphiaPennsylvania19107-
Site 154PhiladelphiaPennsylvania19114-
Site 43PhiladelphiaPennsylvania19104-
Site 89ChattanoogaTennessee37404-
Site 115MemphisTennessee38103-
Site 88NashvilleTennessee37203-
Site 22AustinTexas78745-
Site 1HoustonTexas77030-
Site 18PlanoTexas75075-
Site 17Sugar LandTexas77479-
Site 15TylerTexas75702-
Site 10Salt Lake CityUtah84112-
Site 12BlacksburgVirginia24060-
Site 23NorfolkVirginia23502-

Find similar trials in Mobile, AL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Site 164· Mobile, ALSite 36· La Jolla, CASite 27· Los Angeles, CASite 16· Palo Alto, CASite 19· Newark, DESite 108· Washington D.C., DC

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