Head &Amp; Neck CancerPhase 2CAPT-HNNCT07062354
Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer
A Phase 2 study testing Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) in people with Head &Amp; Neck Cancer and Head &Amp; Neck Squamous Cell Carcinoma, run by SWOG Cancer Research Network at 12 sites in United States.
Trial summary
This research study is for people who have head and neck cancer that has come back or spread to other places in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head &Amp; Neck Cancer, Head &Amp; Neck Squamous Cell Carcinoma
- What is being tested?
- Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesUnited States
- Study dates
- 25 Mar 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically documented squamous cell head and neck carcinoma that meets one of the following criteria; was metastatic at diagnosis, persisted, metastasized or recurred following definitive treatment, or recurred locally and participant has either a contraindication to surgical treatment of lesions (i.e., complete resection is not possible or not expected to be clinically beneficial or resection confers significant functional concerns) or has refused surgical or radiation treatment.
- Both human papillomavirus (HPV) positive and negative are eligible. Participants with cancers originating from the wet lip, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, epiglottis, and nasal cavity/paranasal sinuses are eligible.
- Participants must have measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to registration and non-measurable disease must be assessed within 42 days prior to registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration to be considered measurable.
- Participants must have received prior therapy with a Programmed death ligand 1 (PD-(L)1) inhibitor or PD-1 inhibitor for treatment of head and neck cancer (in any setting).
- Participants must be ≥ 18 years old at the time of registration.
- Participants must have ECOG/Zubrod Performance Status of 0-1.
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- Participants must have a complete medical history and physical exam within 28 days prior to registration.
- Participants must have adequate organ and marrow function within 28 days prior to registration:
- Participants must have a calculated creatinine clearance ≥ 45 mL/min using the Cockcroft-Gault Formula. The specimen for this test must have been drawn and processed within 28 days prior to registration. For creatinine clearance formula see the tools on the CRA Workbench https://txwb.crab.org/TXWB/Tools.aspx.
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration. An undetectable viral load is defined as (1) CD4+ cell count greater or equal to 200 cells/mm3; (2) No history of non-malignancy AIDS defining conditions other than historical low CD4+ cell count.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants must have an undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated.
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System.
- Participants or their legally authorized representative must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and WCG IRB regulations.
Who cannot join
- Participants must not have received more than two prior systemic therapy regimens for recurrent and/or metastatic disease. NOTE: Systemic treatment administered with radiotherapy for radiosensitization in the palliative setting will not be considered a line of therapy.
- Participants must not have had prior anti-cancer therapy within 14 days of registration. Note: Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment while receiving treatment on this study.
- Participants must not have received treatment with a platinum or taxane agent as part of a prior treatment for recurrent or metastatic disease. NOTE: Platinum or taxane agents administered with radiotherapy for radiosensitization in the curative or palliative setting is allowed if there was no evidence of progression within 6 months of last dose of platinum or taxane.
- Participants must not have had prior treatment with cetuximab or another Epidermal Growth Factor Receptor (EGFR) inhibitor in the locally recurrent advanced unresectable or metastatic setting.
- Participants must not have known hypersensitivity and/or contraindication to carboplatin or paclitaxel in the opinion of the treating investigator.
- Participants must not have active cardiovascular disease including but not limited to: Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better. Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration.Participants must not have evidence of preexisting uncontrolled hypertension 28 days prior to Step 1 registration as documented by baseline blood pressure reading with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg. Participants on antihypertensive therapies with controlled blood pressure are eligible. Participants must not have congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class) within 6 months prior to registration.
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- Participants must not have an uncontrolled illness, including but not limited to: Participants must not ongoing uncontrolled diabetes as determined by the treating investigator prior to registration. Participants must not have ongoing or active infection or be diagnosed with or suspected of having a viral infection as determined by the treating investigator. NOTE: Participants who have an infection requiring antimicrobial therapy will be required to complete antibiotics 7 days prior to starting treatment. Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator. Participants must not have a history of pneumonitis that required drug therapy or active symptomatic ILD/pneumonitis, including drug-induced or radiation ILD/pneumonitis. Participants must not have any ophthalmologic condition that is clinically unstable in opinion of treating investigator. Participants must not have active bleeding diathesis as determined by the treating investigator prior to registration. Participants must not have any psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements in opinion of treating investigator.
- Participants must not have had major surgery (excluding placement of vascular access, percutaneous feeding tube replacement, tracheostomy, or tumor biopsy) or had significant traumatic injury within 28 days prior to registration. All adverse events associated with prior surgery must have resolved to ≤ Grade 1 (per CTCAE 5.0) prior to registration. NOTE: Participants must not have surgery planned during the time the participant is expected to participate in the study. Planned surgical procedures to be conducted under local anesthesia are allowable.
- Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated.
- Participants must not have other clinically active infectious liver diseases.
- Participants must not have a concurrent malignancy whose natural history or treatment (in the opinion of the treating investigator) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Medical Univ of South Carolina
Charleston, South Carolina, 29425
Carle at The Riverfront
Danville, Illinois, 61832
Karmanos Cancer Institute
Detroit, Michigan, 48201
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
UCI Health - Chao Family CCC & Ambulatory Care
Irvine, California, 92612
Carle Physician Group - Mattoon/Charleston
Mattoon, Illinois, 61938
Carle Cancer Institute Normal
Normal, Illinois, 61761
University of Nebraska Medical Center
Omaha, Nebraska, 68198
UC Irvine Medical Center
Orange, California, 92868
University of Arizona Cancer Center
Tucson, Arizona, 85719
Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: A Phase II Study of Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer
This research study is for people who have head and neck cancer that has come back or spread to other places in the body.
Read the detailed description
This study is being done to find out if adding amivantamab hyaluronidase to the usual chemotherapy treatment can improve the usual treatment for advanced head and neck cancers.
- Being tested
- Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)Drug
Carboplatin + Paclitaxel + Amivantamab hyaluronidase
| Study group | Role | What they receive |
|---|---|---|
| Participants with unresectable recurrent or metastatic HNSCC | Other | Carboplatin + Paclitaxel + Amivantamab hyaluronidase Receives: Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
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.
Measured: Up to 2 years after registration
Secondary outcomes (8)
Toxicities
To estimate the frequency and severity of toxicities in this participant population.
Measured: Up to 2 years after registration
Clinical Benefit Rate
To estimate the clinical benefit rate (confirmed complete or partial response or stable disease ≥ 6 months) in this participant population.
Measured: Up to 2 years after registration
Disease Control Rate
To estimate the disease control rate (DCR) (confirmed or unconfirmed complete or partial response or stable disease) in this participant population.
Measured: Up to 2 years after registration
Duration of Response
To estimate duration of response in this participant population.
Measured: Up to 2 years after registration
Time to Next Treatment
To estimate time to next treatment in this participant population.
Measured: Up to 2 years after registration
Progression-Free Survival
To estimate progression-free survival in this participant population.
Measured: Up to 2 years after registration
Overall Survival
To estimate overall survival in this participant population.
Measured: Up to 2 years after registration
Overall Response Rate
To estimate the overall response rate by subgroups defined by PD-L1 combined positive score (CPS) ≥ 1 and CPS ≥ 20.
Measured: Up to 2 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start25 Mar 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head &Amp; Neck CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- Janssen Medical Affairs, SWOG Clinical Trials Partnerships, LLC
- Responsible party
- Sponsor
- Investigators
- Paul Swiecicki, MD, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062354
- Sponsor's protocol ID
- 21CTP.HN01
- Other IDs
- 61186372HNC2001
- Acronym
- CAPT-HN
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07062354
- Acronym / sponsor ID
- CAPT-HN / 21CTP.HN01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- Janssen Medical Affairs, SWOG Clinical Trials Partnerships, LLC
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is for people who have head and neck cancer that has come back or spread to other places in the body.
Detailed description
This study is being done to find out if adding amivantamab hyaluronidase to the usual chemotherapy treatment can improve the usual treatment for advanced head and neck cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with unresectable recurrent or metastatic HNSCC | Other | Drug: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)Carboplatin + Paclitaxel + Amivantamab hyaluronidase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must have histologically documented squamous cell head and neck carcinoma that meets one of the following criteria; was metastatic at diagnosis, persisted, metastasized or recurred following definitive treatment, or recurred locally and participant has either a contraindication to surgical treatment of lesions (i.e., complete resection is not possible or not expected to be clinically beneficial or resection confers significant functional concerns) or has refused surgical or radiation treatment.
- Both human papillomavirus (HPV) positive and negative are eligible. Participants with cancers originating from the wet lip, oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, epiglottis, and nasal cavity/paranasal sinuses are eligible.
- Participants must have measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to registration and non-measurable disease must be assessed within 42 days prior to registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration to be considered measurable.
- Participants must have received prior therapy with a Programmed death ligand 1 (PD-(L)1) inhibitor or PD-1 inhibitor for treatment of head and neck cancer (in any setting).
- Participants must be ≥ 18 years old at the time of registration.
Key exclusion criteria (12 listed)
- Participants must not have received more than two prior systemic therapy regimens for recurrent and/or metastatic disease. NOTE: Systemic treatment administered with radiotherapy for radiosensitization in the palliative setting will not be considered a line of therapy.
- Participants must not have had prior anti-cancer therapy within 14 days of registration. Note: Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment while receiving treatment on this study.
- Participants must not have received treatment with a platinum or taxane agent as part of a prior treatment for recurrent or metastatic disease. NOTE: Platinum or taxane agents administered with radiotherapy for radiosensitization in the curative or palliative setting is allowed if there was no evidence of progression within 6 months of last dose of platinum or taxane.
- Participants must not have had prior treatment with cetuximab or another Epidermal Growth Factor Receptor (EGFR) inhibitor in the locally recurrent advanced unresectable or metastatic setting.
- Participants must not have known hypersensitivity and/or contraindication to carboplatin or paclitaxel in the opinion of the treating investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)Carboplatin + Paclitaxel + Amivantamab hyaluronidase | Drug | Participants with unresectable recurrent or metastatic HNSCC |
Primary outcome
Overall Response Rate
Time frame: Up to 2 years after registration
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.
8 secondary outcomes
Toxicities
Time frame: Up to 2 years after registration
Clinical Benefit Rate
Time frame: Up to 2 years after registration
Disease Control Rate
Time frame: Up to 2 years after registration
Duration of Response
Time frame: Up to 2 years after registration
Time to Next Treatment
Time frame: Up to 2 years after registration
Progression-Free Survival
Time frame: Up to 2 years after registration
Overall Survival
Time frame: Up to 2 years after registration
Overall Response Rate
Time frame: Up to 2 years after registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Swiecicki, MD principal investigator
SWOG Cancer Research Network
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) in people with Head &Amp; Neck Cancer and Head &Amp; Neck Squamous Cell Carcinoma, run by SWOG Cancer Research Network at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 2 years after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.