Clinical trial NCT06385080: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer
Official title: A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies. 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: (a) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (b) 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) (c) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) 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; (c) Participants must provide local testing results of PD-L1 status
* Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1
* 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

Exclusion Criteria:

* Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
* Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
* Participant with a history of clinically significant cardiovascular disease
* Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
* Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment

Primary outcomes:
measure: Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
timeFrame: 2 years and 2 months
measure: Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Up to 21 days
measure: Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
timeFrame: 2 years and 1 month
Secondary outcomes:
measure: Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR)
timeFrame: 2 years and 2 months
measure: Cohorts 1, 2, 3B, 4 and 5: Clinical Benefit Rate (CBR)
timeFrame: 2 years and 2 months
measure: Cohorts 1, 2, 3B, 4 and 5: Progression-free Survival (PFS)
timeFrame: 2 years and 2 months
measure: Cohorts 1, 2, 3B, 4 and 5: Overall Survival (OS)
timeFrame: 2 years and 2 months
measure: Cohorts 1, 2, 3B, 4 and 5: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
timeFrame: 2 years and 1 month
measure: Cohort 1 and 4: Maximum Observed Serum Concentration (Cmax) of Amivantamab
timeFrame: Predose up to 168 hours post dose on Day 1
measure: Cohort 1 and 4: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab
timeFrame: Predose up to 168 hours post dose on Day 1
measure: Cohort 1 and 4: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab
timeFrame: Predose up to 168 hours post dose on Day 1
measure: Cohort 1 and 4: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab
timeFrame: Predose up to 168 hours post dose on Day 1
measure: Cohort 1 and 4: Trough Serum Concentration (Ctrough) of Amivantamab
timeFrame: Predose up to 168 hours post dose on Day 1
measure: Cohort 1 and 4: Accumulation Ratio (R) of Amivantamab
timeFrame: Predose up to 168 hours post dose on Day 1
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California at San Diego Moores Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Anschultz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Chicago
country: United States
facility: The University of Chicago Medical Center (UCMC)
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Beijing
country: China
facility: Beijing Cancer Hospital of Peking University
city: Cheng Du Shi
country: China
facility: West China School of Medicine/West China Hospital, Sichuan University
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: ShangHai
country: China
facility: Fudan Cancer Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Lille
country: France
facility: Centre Oscar Lambret
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: PARIS Cedex 5
country: France
facility: Institut Curie
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Stuttgart
country: Germany
facility: Klinikum der Landeshauptstadt Stuttgart
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: ChangHua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Imperial College London and Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals
city: Manchester
country: United Kingdom
facility: The Christie Nhs Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: