Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 (Appendix 2) 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 de novo biopsy will be required for patient participation.
Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.
Difficulty swallowing capsules.
Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)
You may not be if
Prior nasopharyngeal cancer, salivary gland or sinus tumors.
More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
