Weekly chemotherapy and immunotherapy for metastatic head and neck cancer
Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
This study is testing a combination of chemotherapy and immunotherapy to see if it helps people with advanced head and neck cancer feel better compared to using immunotherapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation, prednisone, pembrolizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04858269 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a treatment regimen combining chemotherapy (carboplatin and paclitaxel) with immunotherapy (pembrolizumab) for patients diagnosed with metastatic head and neck squamous cell carcinoma who cannot take 5-fluorouracil. The primary objective is to determine if this combination increases the radiographic response rate compared to historical data for pembrolizumab alone. Secondary objectives include assessing overall survival, progression-free survival, and the toxicity profile of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults with recurrent or metastatic squamous cell carcinoma of the head and neck who are not candidates for 5-fluorouracil.
Not a fit: Patients with head and neck cancer who are eligible for 5-fluorouracil or have localized disease that can be treated with surgery or radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve response rates and survival outcomes for patients with metastatic head and neck cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and immunotherapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis. * Histologic or cytologic confirmation of malignancy by pathology report. * Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other). * 18 years old or greater. * ECOG performance status of 0-2. * Life expectancy of greater than 3 months. * Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * No prior systemic cancer-directed therapy administered in the recurrent or metastatic setting. Prior treatments are allowed if they were administered with curative intent prior to incurable progression of disease. Prior treatments for other cancers are also allowed. * Untreated, symptomatic central nervous system (CNS) metastases. * Active autoimmune disease requiring systemic immunosuppression. * History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone \>20 mg/day for \>1 week). * History of greater than or equal to Grade 3 hypersensitivity reaction to carboplatin or paclitaxel. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because paclitaxel and carboplatin are Class D agents with significant potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued during the study.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest Baptist Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Lycan, DO — Wake Forest Baptist Health Sciences
- Study coordinator: Study Coordinator
- Email: Efrat.Tsivian@Advocatehealth.org
- Phone: 3367165772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.