Study study type PathologyT1T0Patientssample sizesROB Results deaths (OS) Eprogression or deaths (PFS) ERFS/DFS E

mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population

versus cetuximab plus platin plus 5FU
pembrolizumab alone
KEYNOTE-048 (P vs C ; all population), 2019
  NCT02358031
RCTmHNSCC - L1 - all populationpembrolizumabcetuximab with chemotherapy (platine plus 5FU)patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC301 / 300some concern
inconclusive -19% 34%
pembrolizumab plus 5FU plus platin
KEYNOTE-048 (PC vs C ; all population), 2019
  NCT02358031
RCTmHNSCC - L1 - all populationpembrolizumab plus 5 FU plus platinecetuximab plus 5 FU plus platinepatients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC281 / 278some concern
conclusif -14% -8%

mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive

versus cetuximab plus platin plus 5FU
pembrolizumab alone
KEYNOTE-048 (P vs C ; CPS > 20), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumabcetuximab with chemotherapy (platine plus 5FU)patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC133 / 122some concern
conclusif -32% -1%
KEYNOTE-048 (P vs C ; CPS > 1), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapy (cetuximab plus 5FU and platine)patients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC257 / 255some concern
conclusif -26% 16%
pembrolizumab plus 5FU plus platin
KEYNOTE-048 (PC vs C ; CPS > 20), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumab plus 5FU plus platinecetuximab plus 5FU plus platinepatients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC126 / 110some concern
conclusif -41% -27%
KEYNOTE-048 (PC vs C ; CPS > 1), 2019
  NCT02358031
RCTmHNSCC - L1 - PDL1 positivepembrolizumab plus 5FU plus platinecetuximab plus 5FU plus platinepatients with recurrent or metastatic squamous cell carcinoma of the head and neck, untreated locally incurable recurrent or metastatic HNSCC242 / 226some concern
conclusif -26% -18%