A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L/A) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease

• Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1.

• Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes \[any grade\], Grade less than or equal to \[\<=\]2 peripheral neuropathy and Grade \<=2 hypothyroidism stable on hormone replacement)

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test.

⁃ Participants should have: a) Hemoglobin \>=9 grams per deciliter (g/dL); b) Neutrophils \>=1.5 x 10\^3/mcg; c) Platelets \>=100 x 10\^3/mcg

Locations
United States
California
University of California at San Diego Moores Cancer Center
COMPLETED
La Jolla
Colorado
University of Colorado Denver Anschultz Medical Campus
RECRUITING
Aurora
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Illinois
The University of Chicago Medical Center (UCMC)
RECRUITING
Chicago
Maryland
University of Maryland School of Medicine
RECRUITING
Baltimore
Michigan
University of Michigan Rogel Cancer Center
RECRUITING
Ann Arbor
Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Utah
University of Utah Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
China
Beijing Cancer Hospital of Peking University
RECRUITING
Beijing
West China School of Medicine/West China Hospital, Sichuan University
RECRUITING
Cheng Du Shi
Linyi Cancer Hospital
RECRUITING
Linyi
Fudan Cancer Hospital
RECRUITING
Shanghai
Shanghai East Hospital
RECRUITING
Shanghai
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
France
Institut Sainte Catherine
RECRUITING
Avignon
Centre Oscar Lambret
RECRUITING
Lille
CHU Nantes
RECRUITING
Nantes
Institut Curie
RECRUITING
Paris
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitaetsklinikum Essen
RECRUITING
Essen
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Klinikum der Landeshauptstadt Stuttgart
RECRUITING
Stuttgart
Japan
Aichi Cancer Center
RECRUITING
Nagoya
Tokyo Medical University Hospital
RECRUITING
Tokyo
Malaysia
Pantai Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
RECRUITING
Gliwice
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Spain
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Inst. Cat. Doncologia-H Duran I Reynals
RECRUITING
Barcelona
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
The Royal Surrey County Hospital NHS Foundation Trust
RECRUITING
Guildford
Imperial College London and Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Marsden Hospital
RECRUITING
London
University College London Hospitals
RECRUITING
London
The Christie Nhs Foundation Trust
RECRUITING
Manchester
Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2032-12-27
Participants
Target number of participants: 287
Treatments
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.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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