CAPT-HN: A Phase II Study of COMBINED Amivantamab, carboPlatin, and pacliTaxel in UNRESECTABLE LOCALLY recurrent OR metastatic Head and Neck cancer


Paul Swiecicki, MD (Primary Chair)
&
Cristina P. Rodriguez, MD (Medical Oncology)

ACTIVATED:  9/15/2025

For sites that are members of the SWOG Cancer Research Network ONLY:
If your site is interested in applying to open this study, please complete the feasibility questionnaire. It collects essential information to help us assess each site’s suitability for the study.

Please note, this study uses amivantamab hyaluronidase (SubQ administration).

View Trial Page at ClinicalTrials.gov

21CTP.HN01 Study synopsis

Schema

21CTP.HN01 schema

Key Eligibility

Inclusion criteria

  1. Histologically documented squamous cell head and neck carcinoma that
    1. was metastatic at diagnosis OR
    2. persisted, metastasized, or recurred after definitive treatment OR
    3. recurred locally and patient has contraindication to surgery or has refused surgery or radiation
  2. Both HPV positive and negative are eligible
  3. Cancers may originate from the wet lip, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, epiglottis, or nasal cavity/paranasal sinuses
  4. Presence of measurable disease by CT or MRI within 28 days of registration
  5. Must have received prior treatment for head and neck cancer with a systemic PD-(L)1 or PD-1 inhibitor (in any setting)
  6. Up to two prior systemic therapy regimens for recurrent and/or metastatic disease
  7. ECOG performance status of 0-1
  8. Age 18 years or older
  9. Complete medical history and physical exam, with adequate organ and bone marrow function, with 28 days of registration
  10. Must have calculated creatinine clearance >=45 mL/min using Cockcroft-Gault formula
  11. If HIV-positive, must be on antiretroviral therapy with undetectable viral load on most recent test, within 6 months of registration
  12. If history of hepatitis C, must have been treated and cured
  13. If history of chronic hepatitis B, must have undetectable viral load on suppressive therapy on most recent test, within 6 months of registration
  14. If of reproductive potential, must agree to use effective contraceptive method

Exclusion criteria

  1. Prior anti-cancer therapy within 14 days of registration
  2. Received platinum or taxane agent as part of prior treatment for recurrent or metastatic disease
  3. Prior treatment with cetuximab or another EGFR inhibitor in the locally recurrent advanced unresectable or metastatic setting
  4. Hypersensitivity and/or contraindication to carboplatin or paclitaxel
  5. Active cardiovascular disease
  6. Congestive heart failure within 6 months of registration
  7. An uncontrolled illness
  8. Major surgery or significant traumatic injury within 28 days of registration
  9. Surgery planned during time of expected study participation
  10. Other clinically active or infectious liver diseases
  11. Concurrent malignancy whose natural history or treatment has potential to interfere with safety or efficacy assessment of the investigational regimen
  12. Pregnant or nursing
Objectives

Primary

  • a. To assess the overall response rate (ORR) (confirmed complete and partial responses per RECIST 1.1) of amivantamab hyaluronidase + carboplatin + paclitaxel in participants with platinum naïve unresectable recurrent or metastatic head and neck squamous cell carcinoma previously treated with a PD-1 inhibitor.

Secondary

  • a. To estimate the frequency and severity of toxicities in this participant population.
  • b. To estimate the clinical benefit rate (confirmed complete or partial response or stable disease ≥ 6 months) in this participant population.
  • c. To estimate the disease control rate (DCR) (confirmed or unconfirmed complete or partial response or stable disease) in this participant population.
  • d. To estimate duration of response in this participant population.
  • e. To estimate time to next treatment in this participant population.
  • f. To estimate progression-free survival in this participant population.
  • g. To estimate overall survival in this participant population.

Banking

  • a. To bank specimens for future correlative studies

Study Contact Information

Funding Questions:
[email protected]

Protocol Questions Contact:
[email protected]

Frequently Asked Questions

View Trial Page at ClinicalTrials.gov