PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT02819752
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab
  • Radiotherapy — RADIATION
    Radiotherapy - Standard Treatment
  • Chemotherapy — DRUG
    Chemotherapy - Standard Treatment

Study Details

This study aims to establish whether the combination of pembrolizumab (MK-3475) and conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as these are the primary acute toxicities associated with this treatment regimen. In addition, toxicity outside the radiation portals (which may theoretically be exacerbated by radiation) will be studied. However, all toxicity will be monitored. This study will also give an indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately selecting a group of patients with high- and intermediate-risk disease who have a significant chance of experiencing loco-regional or systemic failure.

Key Dates

Start date
Jul 12, 2017
Status verified
Mar 2026
Primary completion
Nov 28, 2019
Completion
Nov 28, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: HPV-ve stage IVA/IVB SCCHN
    Pembrolizumab and Chemoradiotherapy
  • Experimental: HPV+ve stage IVA/IVB SCCHN
    Pembrolizumab and Chemoradiotherapy

Primary Outcome Measure

Number and Percentage of Patients With Dose Limiting Toxicities (DLT). [ Time Frame: Six weeks after the completion of chemoradiotherapy ]

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