REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors
Status:
Recruiting
Trial end date:
2040-11-02
Target enrollment:
Participant gender:
Summary
Each subject will participate in the trial until death, drop out, or loss-to follow-up from
the time the subject signs the Informed Consent Form (ICF) through the final contact. After a
screening phase of up to 28 days, each eligible subject will receive nivolumab. Two weeks
after start of nivolumab the patients will receive radiotherapy (RT) to a total dose of 60
Gy, given as 1.5 Gy fractions twice daily for a total period of 4 weeks. Treatment with
nivolumab will continue until disease progression, unacceptable adverse event(s),
intercurrent illness that prevents further administration of treatment, Investigator's
decision to withdraw the subject, noncompliance with trial treatment or procedures
requirements, subject receives nivolumab for 12 months, pregnancy, or administrative reasons.
After the end of treatment, each subject will be followed for 30 days for adverse event
monitoring serious adverse events (SAEs) will be collected for 90 days after the end of
treatment. Patients without disease progression will have follow-up visits for 4 years after
end of study therapy.