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Protocol No.1456GCCPrincipal InvestigatorCullen, Kevin
PhasePhase II
Age GroupAdult
TitleA Phase II trial of reirradiation combined with open label Pembrolizumab in patients with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck (SCCHN)
DescriptionRe-irradiation for 5 weeks + MK-3475 (Keytruda) by vein once every 3 weeks for 18 weeks (6 cycles). Some patients may qualify to stay on MK-3475 (Keytruda), depending on the initial treatment response.
Treatment--Re-irradiation for 5 weeks --MK-3475 (Keytruda) for 6 cycles (18 weeks)
Key Eligibility--18 years of age or older
--Have had only one prior course of radiation therapy with a curative intent at least 6 months ago
--Willing to have feeding tube placed, if needed
--Life expectancy greater than 12 weeks
--Adequate organ function based on laboratory results
--No metastatic disease
--No current investigational treatments
--No currently active or history of autoimmune disease requiring systemic steroid or immunosuppressive agents
--No history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease or currently active, non-infectious pneumonitis.
Applicable Disease SitesEsophagus
Eye and Orbit
Lip, Oral Cavity and Pharynx
Therapies InvolvedImmunotherapy
Drugs InvolvedMK-3475
Treatment TypeTreatment
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