Efficacy assessments
tumor
DISEASE PROGRESSION, DISEASE, PROGRESSION, TUMOR
Patients were considered evaluable for clinical response if they had measurable disease present at baseline, received at least one cycle of therapy, developed objective disease progression prior to the end of cycle 1, or had their disease re-evaluated by imaging at the conclusion of cycle 1. Radiologic assessment, including CT, MRI, or PET-CT as appropriate, was performed within 28 days prior to initial infusion and was repeated thereafter every 2 cycles. CEA levels and other tumor marker evaluations if appropriate were performed at these time points as well. Response was determined by a blinded central reviewer. Preliminary evidence of efficacy was determined by RECIST v1.1 guideline and reported as Objective Response Rate (ORR) (ORR = complete response (CR), partial response (PR), SD) and Progression Free Survival (PFS).