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).

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 calendar

21CTP.HN01 study calendar

Footnotes

NOTE: Forms are found on the protocol-specific page on the SWOG website (www.swog.org).

NOTE: For information regarding the Monitoring Plan: Toxicity see Section 11.5.

Unless indicated otherwise in the protocol, scheduled procedures and assessments (treatment administration, toxicity assessment for continuous treatment, disease assessment, specimen collection, and follow up activities) must follow the guidelines established in the SWOG Best Practices document which is accessible from the Protocol Workbench at https://www.swog.org/clinical-trials/protocol-workbench.

A. Disease assessment will be performed with CT or MRI imaging (the same method used at pre-registration) every six weeks for 24 weeks, then every 12 weeks until progression. If the participant remains on protocol treatment after progression due to clinical benefit in the opinion of the treating investigator, scans must continue per schedule until treatment is discontinued. Neck and Chest Imaging with IV contrast will be obtained in all participants unless the participant has a documented severe contrast allergy which cannot be appropriately managed with the use of pre-medications. Either CT or MRI are acceptable and may be used at the discretion of the treating physician. Further imaging (i.e., CT Abdomen/Pelvis, CT/MRI Brain, Bone Scan) will be performed as deemed appropriate by the treating physician.

B. Measurable disease must be assessed within 28 days prior to registration and non- measurable disease must be assessed within 42 days prior to registration.

C. See Section 15 for details.

D. Collect urine at the following timepoints: Pre-treatment and at home daily for Cycle 1 Day 1 through Cycle 1 Day 7 (i.e., C1D1, D2, D3, D4, D5, D6, C1D7) and at recurrence or end of treatment. Participants will be given kits with instructions regarding daily self-collection, specimen storage, and shipping. A final kit is provided for end of treatment.

E. If labs obtained within 14 days prior to treatment, tests need not be repeated on C1D1.

F. Please see Section 5.3.d for details. (Without transfusion within 14 days prior to Cycle 1, Day 1).

G. Please see Section 5.3.d for details. CMP includes Basic Metabolic Profile (Na, K, Cl, CO2, BUN, Cr, Glu), AST/SGOT, ALT/SGPT, Alk Phos, T Bili, Albumin, Ca, and Total P.

H. Please see Section 5.3 for details.

I. Survival assessment can be done by phone and will be performed once every three months (+/- 1 month) after discontinuation of protocol treatment. Follow up will be until death or 2 years after registration, whichever occurs first.

J. Treatment with amivantamab hyaluronidase will continue until one of the criteria for removal has been met in Section 7.4.

K. As clinically indicated, strongly recommended, but medical records must document necessity.

funding memo

21CTP.HN01 funding memo

*Pre-Activation Checklist-

  • Form FDA 1572
  • DTL (Delegation of Tasks Log)
  • CVs (curriculum vitae)
  • FDFs (Financial Disclosure Forms)
  • Medical Licenses
  • GCP Training Certs.
  • Florence Training Certs.
  • Site Signature Page

Study Contact Information

Funding Questions:
[email protected]

Protocol Questions Contact:
[email protected]

 

Frequently Asked Questions