Trial Title:
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer
NCT ID:
NCT06385080
Condition:
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Recurrence
Paclitaxel
Pembrolizumab
Amivantamab-vmjw
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Amivantamab
Description:
Amivantamab will be administered subcutaneously.
Arm group label:
Cohort 1: Amivantamab Monotherapy (Dose Expansion)
Arm group label:
Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)
Arm group label:
Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel
Arm group label:
Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel
Other name:
JNJ-61186372
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab will be administered intravenously.
Arm group label:
Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)
Other name:
KEYTRUDA
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel will be administered intravenously.
Arm group label:
Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel
Arm group label:
Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel
Other name:
TAXOL
Summary:
The purpose of this study is to determine safety and preliminary efficacy of amivantamab
monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to
paclitaxel 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.
Criteria for 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:
(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
- Participants in Cohorts 1, 2, and 3B 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Denver Anschultz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Chicago Medical Center (UCMC)
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201 2013
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School Of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Utah Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pantai Hospital Kuala Lumpur
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital
Address:
City:
ChangHua
Zip:
500
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Kung Memorial Hospital
Address:
City:
Kaohsiung City
Zip:
833
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Linkou Chang Gung Memorial Hospital
Address:
City:
Taoyuan
Zip:
33382
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Royal Surrey County Hospital NHS Foundation Trust
Address:
City:
Guildford
Zip:
GU2 7XX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Imperial College London and Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie Nhs Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
April 22, 2024
Completion date:
April 15, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385080
