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Protocol No.1456GCCPrincipal InvestigatorZandberg, Dan
PhasePhase II
Age GroupAdult
Title1456GCC: A 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
Larynx
Lip, Oral Cavity and Pharynx
Therapies InvolvedImmunotherapy
Radiotherapy
Drugs InvolvedMK-3475
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02289209
ContactGreenebaum Cancer Center Navid Saeidi, MS Phone:410-328-6465
Pager:410-328-2337 #7678
Email:Navid.saeidi@umm.edu
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