Clin2
NCT04671667Possibly a fitRecruiting

Pembrolizumab vs chemo-radiation after surgery for recurrent head/neck cancer

Recurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell Carcinoma

Treatments studied

Part of Cancer clinical trials.

This trial tests whether pembrolizumab (an immunotherapy drug) works better than the usual chemo plus radiation after surgery for cancer that has come back in the head and neck area. It may help reduce cancer returning or spreading by using your immune system, but eligibility depends on how the cancer came back and your prior treatments.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
188 people
Ages
18 years to 79 years
Study type
Interventional

Who can take part

  • Be age 18–79
  • Have head and neck squamous cell cancer that has come back or is a second new cancer in the mouth/throat areas, and it must be in a previously radiated field
  • Have had surgery to remove the tumor completely (gross total resection) within the last 8 weeks, with high-risk features like positive surgical margins and/or extra spread in lymph nodes beyond the original tumor (ENE)
  • Get tumor testing showing PD-L1 CPS score of 1 or higher from your removed/resected tumor sample (done in a CLIA-certified lab)
  • Have had radiation to that same area before, with at least 6 months since finishing radiation, and no evidence of cancer spread to distant organs on a scan within 28 days
  • Be well enough to participate (ECOG 0–1), and not have had an anti–PD-1/PD-L1 immunotherapy for the recurrent cancer in the recent past (it must be stopped >1 year ago if received before as initial treatment)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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