Pembrolizumab in Combination With CRT for LA-SCCHN

Summary

Participation Requirements

Description

Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. After a screening phase of 28 days, eligible subjects will receive treatment on Day -7 with a loading dose of the study drug. This will continue du...

Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final protocol-specified contact. After a screening phase of 28 days, eligible subjects will receive treatment on Day -7 with a loading dose of the study drug. This will continue during concurrent therapy with cisplatin and radiation, which will begin on day 1. Treatment will continue until completion of therapy, documented confirmed disease progression, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdraws consent, pregnancy of the patient, noncompliance with trial treatment or procedure requirements; or administrative reasons. After the end of treatment, each patient will be followed for 30 days for adverse event monitoring (serious adverse events will be collected for 90 days after the end of treatment or 30 days after the end of treatment if the patient initiates new anticancer therapy, whichever is earlier). Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until end of study disease progression, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival until death, withdrawal of consent, or the Investigator is notified by Sanford Research to discontinue follow-up

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