SWOG clinical trial number
21CTP.HN01
Phase II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (CAPT-HN) Study Synopsis
Open
Phase
Accrual
0%
Abbreviated Title
CAPT-HN
Status Notes
Activation - Effective 09/15/2025
SWOG Clinical Trials Partinerships
https://www.swogctp.org/trials/21ctphn01/
SWOG Clinical Trials Partinerships
https://www.swogctp.org/trials/21ctphn01/
Activated
09/15/2025
Participants
SWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING
Research committees
SWOG CTP
Head and Neck Cancer
Treatment
Paclitaxel
Carboplatin
Amivantamab
Eligibility Criteria Expand/Collapse
Inclusion criteria
Histologically documented squamous cell head and neck carcinoma that
was metastatic at diagnosis OR
persisted, metastasized, or recurred after definitive treatment OR
recurred locally and patient has contraindication to surgery or has refused surgery or radiation
Both HPV positive and negative are eligible
Cancers may originate from the wet lip, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, epiglottis, or nasal cavity/paranasal sinuses
Presence of measurable disease by CT or MRI within 28 days of registration
Must have received prior treatment for head and neck cancer with a systemic PD-(L)1 or PD-1 inhibitor (in any setting)
Up to two prior systemic therapy regimens for recurrent and/or metastatic disease
ECOG performance status of 0-1
Age 18 years or older
Complete medical history and physical exam, with adequate organ and bone marrow function, with 28 days of registration
Must have calculated creatinine clearance >=45 mL/min using Cockcroft-Gault formula
If HIV-positive, must be on antiretroviral therapy with undetectable viral load on most recent test, within 6 months of registration
If history of hepatitis C, must have been treated and cured
If history of chronic hepatitis B, must have undetectable viral load on suppressive therapy on most recent test, within 6 months of registration
If of reproductive potential, must agree to use effective contraceptive method
Exclusion criteria
Prior anti-cancer therapy within 14 days of registration
Received platinum or taxane agent as part of prior treatment for recurrent or metastatic disease
Prior treatment with cetuximab or another EGFR inhibitor in the locally recurrent advanced unresectable or metastatic setting
Hypersensitivity and/or contraindication to carboplatin or paclitaxel
Active cardiovascular disease
Congestive heart failure within 6 months of registration
An uncontrolled illness
Major surgery or significant traumatic injury within 28 days of registration
Surgery planned during time of expected study participation
Other clinically active or infectious liver diseases
Concurrent malignancy whose natural history or treatment has potential to interfere with safety or efficacy assessment of the investigational regimen
Pregnant or nursing
Histologically documented squamous cell head and neck carcinoma that
was metastatic at diagnosis OR
persisted, metastasized, or recurred after definitive treatment OR
recurred locally and patient has contraindication to surgery or has refused surgery or radiation
Both HPV positive and negative are eligible
Cancers may originate from the wet lip, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, epiglottis, or nasal cavity/paranasal sinuses
Presence of measurable disease by CT or MRI within 28 days of registration
Must have received prior treatment for head and neck cancer with a systemic PD-(L)1 or PD-1 inhibitor (in any setting)
Up to two prior systemic therapy regimens for recurrent and/or metastatic disease
ECOG performance status of 0-1
Age 18 years or older
Complete medical history and physical exam, with adequate organ and bone marrow function, with 28 days of registration
Must have calculated creatinine clearance >=45 mL/min using Cockcroft-Gault formula
If HIV-positive, must be on antiretroviral therapy with undetectable viral load on most recent test, within 6 months of registration
If history of hepatitis C, must have been treated and cured
If history of chronic hepatitis B, must have undetectable viral load on suppressive therapy on most recent test, within 6 months of registration
If of reproductive potential, must agree to use effective contraceptive method
Exclusion criteria
Prior anti-cancer therapy within 14 days of registration
Received platinum or taxane agent as part of prior treatment for recurrent or metastatic disease
Prior treatment with cetuximab or another EGFR inhibitor in the locally recurrent advanced unresectable or metastatic setting
Hypersensitivity and/or contraindication to carboplatin or paclitaxel
Active cardiovascular disease
Congestive heart failure within 6 months of registration
An uncontrolled illness
Major surgery or significant traumatic injury within 28 days of registration
Surgery planned during time of expected study participation
Other clinically active or infectious liver diseases
Concurrent malignancy whose natural history or treatment has potential to interfere with safety or efficacy assessment of the investigational regimen
Pregnant or nursing