NCT04858269
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentWake Forest University Health SciencesInvestigator-initiated
~31 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:PembrolizumabCarboplatinPaclitaxel
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response Rate
Measured over At 18 weeks on study
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Thomas Lycan, DO · PRINCIPAL_INVESTIGATOR · Wake Forest Baptist Health Sciences
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Response RateAt 18 weeks on study
Using RECIST 1.1 will be defined as the percentage of analyzed participants with a complete response (defined as disappearance of all target lesions) or partial response (defined as decrease by ≥ 30% in sum of longest diameter of target lesions) as compared to the historical objective response rate (19%) reported for pembrolizumab alone.