A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06385080
Phase
PHASE1/PHASE2
Status
Recruiting
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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 subcutaneously.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered intravenously.
  • Paclitaxel — DRUG
    Paclitaxel will be administered intravenously.
  • Carboplatin — DRUG
    Carboplatin will be administered intravenously.

Study Details

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Key Dates

Start date
Apr 22, 2024
Status verified
Jun 2026
Primary completion
Dec 27, 2027
Completion
Dec 27, 2032

Study Design

Enrollment
287 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Amivantamab Monotherapy (Dose Expansion)
    Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight \>=80 kilograms \[kg\]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards.
  • Experimental: Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)
    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous (IV) injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle).
  • Experimental: Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel
    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A.
  • Experimental: Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel
    Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A.
  • Experimental: Cohort 4: Amivantamab Monotherapy
    Participants will receive subcutaneous injection of amivantamab monotherapy 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards.
  • Experimental: Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion)
    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards in addition to intravenous injection of pembrolizumab 200 mg on Day 1 of each cycle, and carboplatin (area under the concentration-time curve \[AUC\] 5 milligram per milliliter \[mg/ml\]\*min) q3w on Day 1 of Cycles 1-6.
  • Experimental: Cohort 6: Amivantamab + Pembrolizumab
    Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle) (Neoadjuvant Phase). In the adjuvant phase, pembrolizumab IV (200 mg) will be administered q3w from Adjuvant Cycle 1 Day 1 to Adjuvant Cycle 15 Day 1 and amivantamab SC 2,400 mg (3,360 mg for \>80 kg) will be administered q3w from Adjuvant Cycle 4 Day 1 to Adjuvant Cycle 15 Day 1.

Primary Outcome Measure

Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate [ Time Frame: 2 years and 2 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
University of California at San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of Colorado Denver Anschultz Medical CampusAuroraColorado80045-
Yale Cancer CenterNew HavenConnecticut06520-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
University of Maryland School of MedicineBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Karmanos Cancer InstituteDetroitMichigan48201 2013-
Washington University School Of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Cleveland ClinicClevelandOhio44195-
University of Utah Huntsman Cancer InstituteSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22903-
Virginia Cancer SpecialistsFairfaxVirginia22031-

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By research site
University of California at San Diego Moores Cancer Center· La Jolla, CAUniversity of Colorado Denver Anschultz Medical Campus· Aurora, COYale Cancer Center· New Haven, CTThe University of Chicago Medical Center (UCMC)· Chicago, ILUniversity of Maryland School of Medicine· Baltimore, MDDana Farber Cancer Institute· Boston, MA

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