Study on Amivantamab, Carboplatin, and Paclitaxel for Advanced Head and Neck Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT07062354
This clinical trial is exploring whether adding the drug amivantamab to standard chemotherapy can improve treatment for people with advanced head and neck cancer that cannot be surgically removed or has spread.
Patient Parameters
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Program Overview
This study is for individuals with head and neck cancer that has either returned after treatment or spread to other parts of the body. Researchers are testing if adding a new drug, amivantamab, to the usual chemotherapy drugs carboplatin and paclitaxel can enhance treatment outcomes for these patients.
Description
The study aims to determine if the addition of amivantamab hyaluronidase to standard chemotherapy can improve treatment for advanced head and neck cancers. Participants will receive a combination of amivantamab, carboplatin, and paclitaxel to see if this combination is more effective than the usual treatment alone.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of squamous cell head and neck cancer that is either metastatic, persistent, or has recurred after treatment.
- Cancer must be measurable by CT or MRI scans.
- Must have previously received treatment with a PD-(L)1 or PD-1 inhibitor for head and neck cancer.
- Must be 18 years or older.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have a complete medical history and physical exam within 28 days before joining the study.
- Must have adequate organ and bone marrow function.
- Must have a creatinine clearance of at least 45 mL/min.
- If HIV-positive, must be on effective anti-retroviral therapy with an undetectable viral load.
- If previously infected with hepatitis C, must have been treated and cured.
- Must agree to participate in specimen banking.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Must not have received more than two prior systemic therapy regimens for recurrent or metastatic disease.
- Must not have had any anti-cancer therapy within 14 days before joining the study.
- Must not have received platinum or taxane agents for recurrent or metastatic disease unless used with radiotherapy for radiosensitization.
- Must not have been treated with cetuximab or another EGFR inhibitor in the advanced setting.
- Must not have allergies or contraindications to carboplatin or paclitaxel.
- Must not have active cardiovascular disease or uncontrolled high blood pressure.
- Must not have uncontrolled illnesses, infections, or require continuous oxygen.
- Must not have had major surgery within 28 days before joining the study.
- Must not have active hepatitis B or other infectious liver diseases.
- Must not have another active cancer that could interfere with the study.
- Must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arizona Cancer Center | 85719 | Tucson | Arizona |
| University of Michigan Rogel Cancer Center | 48109 | Ann Arbor | Michigan |
| University of Nebraska Medical Center | 68198 | Omaha | Nebraska |
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