Treatment decisions when therapy must be discontinued Sample Clauses

Treatment decisions when therapy must be discontinued. Treatment must be permanently discontinued if: • Pembrolizumab must be held for greater than 12 weeks study therapy. • Greater or equal to Grade 2 toxicity attributed to the AE37 vaccine persists for > 28 days. The patient will not receive further vaccination and will discontinue study therapy. See Table 3. Note: Should pembrolizumab be permanently discontinued prior to Cycle 5; AE37 vaccinations should continue per study schedule unless otherwise contraindicated. • Consent is withdrawn or patient is lost to follow-up. • An adverse event occurs that, in the opinion of the investigator or sponsor, contradicts further dosing. See Table 9. • The patient becomes pregnant or intends to conceive a child while actively on study. • Grade 3 or greater infusion reaction occurs. • If tumor progression occurs during study therapy.
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