Radiotherapy With Pembrolizumab in Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT03386357
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • A (pembrolizumab+RT) — COMBINATION_PRODUCT
    Pembrolizumab (200mg absolute, q3w) combined with radiotherapy (12x3Gy) of one, two or three metastases. Only metastases that perspectively require radiotherapy will be treated. The irradiated tumor volume must be at least 10cm³. Radiotherapy of brain metastases is not allowed.
  • B (pembrolizumab) — DRUG
    Pembrolizumab (200mg absolute, q3w)

Study Details

Randomized phase II study of immune stimulation with Pembrolizumab and radiotherapy in second line therapy of metastatic head and neck squamous cell carcinoma.

Key Dates

Start date
Jul 20, 2018
Status verified
Oct 2024
Primary completion
Oct 1, 2024
Completion
Oct 1, 2024

Study Design

Enrollment
115 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A (pembrolizumab+RT)
    Pembrolizumab (200mg absolute, q3w) combined with radiotherapy (12x3Gy) of one, two or three metastases.
  • Active Comparator: B (pembrolizumab)
    Pembrolizumab (200mg absolute, q3w) without radiotherapy

Primary Outcome Measure

Best Response According to iRECIST Criteria [ Time Frame: Endpoint is the best response during pembrolizumab treatment (restaging every 9 weeks up to 12 months) ]

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