A Study of the Safety And Effectiveness of Palbociclib Plus Cetuximab versus Cetuximab Alone to Treat Head and Neck Cancer


About this study

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab alone in prolonging overall survival in human papillomavirus-negative patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
  • Measurable disease as defined per RECIST v. 1.1
    • Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented
  • HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays)
  • Documented progressive disease according to RECIST v1.1  following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin)
  • Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis
    • If archived tumor tissue is not available, then a new biopsy will be required for patient participation

Exclusion Criteria

  • Prior nasopharyngeal cancer, salivary gland or sinus tumors
  • More than one chemotherapeutic regimen given for R/M disease
    • Prior treatment with immunotherapy is allowed
  • Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth
    • Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization
  • Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN
  • Difficulty swallowing capsules or requirement for a feeding tube
  • Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Katharine Price, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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