97TiP - KEYNOTE-629: Phase 2 Trial of Pembrolizumab in Patients (pts) with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) (97TiP)

Date 08 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Lunch & Poster Display session
Topics Bioethics, Legal, and Economic Issues
Presenter Lisa Licitra
Citation Annals of Oncology (2017) 28 (suppl_11): xi6-xi29. 10.1093/annonc/mdx711
Authors L. Licitra1, L. Siu2, E. Cohen3, P. Zhang4, B. Gumuscu4, R. Swaby4, K. Harrington5
  • 1Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 2M9 - Toronto/CA
  • 3Department Of Medicine, University of California, San Diego, Moores Cancer Center, 92093 - La Jolla/US
  • 4Oncology, Merck & Co., Inc., Kenilworth/US
  • 5Head And Neck/skin Units, The Institute of Cancer Research, London/GB



There are no approved treatments and no current standard of care for recurrent or metastatic cSCC. Regimens that are effective for squamous cell carcinoma of the head and neck (HNSCC) may also be effective for cSCC. Cisplatin- and cetuximab-based regimens are commonly used in recurrent or metastatic cSCC; however, supporting evidence for their efficacy is limited. Pembrolizumab is a PD-1 inhibitor that directly blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Pembrolizumab has demonstrated evidence of efficacy and safety in patients with recurrent or metastatic HNSCC in the phase 1b KEYNOTE-012 study. This single-arm, open-label phase 2 trial will evaluate the efficacy and tolerability of pembrolizumab in pts with previously treated recurrent or metastatic cSCC (NCT03284424).

Trial design

120 pts will be enrolled. Key inclusion criteria are: age ≥18 years; histologically-confirmed cSCC as the primary site of malignancy; metastatic disease and/or locally recurrent disease not curable by surgery, radiation, or systemic therapy; previously treated with a platinum- or cetuximab-based regimen; measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and Eastern Cooperative Oncology Group performance status 0-1. Pts will be treated with pembrolizumab 200 mg every 3 weeks by intravenous infusion, continued for 35 doses (∼2 years) or until disease progression, unacceptable toxicity, intercurrent illness, noncompliance, or investigator or pt decision to withdraw. The primary endpoint is the objective response rate per RECIST 1.1 assessed by blinded independent central review. Secondary endpoints include duration of response, disease control rate (complete or partial response or stable disease for ≥12 weeks), and progression-free survival per RECIST 1.1, and overall survival, safety and tolerability. Pharmacokinetics, biomarkers, and health-related quality of life will be evaluated as exploratory endpoints.

Clinical trial identification


Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.


L. Licitra: Travel expenses, including accommodations: Merck-Serono, Debiopharm, Jobi, Bayer, Amgen Consulting or Advisory Role: Eisai, BMS, MSA, Merck-Serono, BMS, Debiopharm, Jobi, Novartis, AstraZeneca, Bayer, Roche, Amgen. L. Siu: Advisory board member: Merck Research funding: Merck (clinical trial). E. Cohen: Advisory board member/Consulting: Eisai; Pfizer; AstraZeneca; Bristol-Myers Squibb; Human Longevity, Inc. P. Zhang, R. Swaby: Employment and stock ownership: Merck. B. Gumuscu: Employment and stock ownership: Merck Sharp & Dohme Travel expenses, including accommodations: Merck Sharp & Dohme. K. Harrington: Advisory board member: Amgen, AZ, BMS, Merck-Serono, MSD, Pfizer Speakers’ bureau: Amgen, AZ, BMS, Merck-Serono, MSD Research funding: AZ, MSD Honoraria: Amgen, AZ, BMS, Merck-Serono, MSD, Pfizer.