INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Part of paid clinical trials in Duarte, California.

Sponsor
Inhibrx Biosciences, Inc
Study ID
NCT06295731
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

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

Interventions

  • INBRX-106 — DRUG
    INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)

Study Details

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.

Key Dates

First listed
Mar 6, 2024
Start date
May 14, 2024
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

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

Arms

  • Experimental: INBRX-106 plus pembrolizumab
    Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)
  • Active Comparator: pembrolizumab monotherapy (+ placebo in phase 3 part)
    Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)

Primary Outcome Measure

Phase 2: Objective Response Rate (ORR) [ Time Frame: up to 6 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Los Angeles Cancer Network (LACN)Los AngelesCalifornia91204-
UC DavisSacramentoCalifornia95817-
Medical Oncology Associates of San DiegoSan DiegoCalifornia92123-
Sarcoma Oncology CenterSanta MonicaCalifornia90403-
ChristianaCare Health ServicesNewarkDelaware19713-
University of Florida UF Health Cancer CenterGainesvilleFlorida32608-
The Oncology Institute of Hope & InnovationMiamiFlorida33169-
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
Cleveland Clinic Florida, The Maroone Cancer CenterWestonFlorida33331-
University of Illinois Cancer CenterChicagoIllinois60612-
Norton Cancer InstituteLouisvilleKentucky40202-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University St. LouisSt LouisMissouri63110-
Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of MontanaBillingsMontana59102-
Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Christus St. Vincent Regional Cancer CenterSanta FeNew Mexico87505-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-7305-
Oklahoma University Stephenson Cancer CenterOklahoma CityOklahoma73104-
Oregon Health & Science UniversityPortlandOregon97239-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
CHRISTUS Spohn Cancer CenterCorpus ChristiTexas78404-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CALos Angeles Cancer Network (LACN)· Los Angeles, CAUC Davis· Sacramento, CAMedical Oncology Associates of San Diego· San Diego, CASarcoma Oncology Center· Santa Monica, CAChristianaCare Health Services· Newark, DE

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