2009 Jan;45(2):228-47. Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 75APPENDIX F: Immune Rela ted Response Criteria For all patients who experien ce disease progression on study, th e date noted for of disease progression is the time of the scan where it is originally detected, and not the following date of the confirmatory scan. Definitions of measurable a nd non-measurable disease Measurable disease: Neoplastic masses that can be precisely measured in 2 in-plane perpendicular diameters. Both its longest diameter and its longest perpendicular must be greater than or equal to 10 mm. Lymph nodes must have a short-axis line-length of ≥ 15 mm. Malignant lymph nodes must be measurable in 2 perpendicular diameters. Both its longest diameter and its longest perpendicular must be greater than or equal to 15 mm. The quantitative endpoint will be defined as the product of the longest diam eter with its longes t perpendicular. Non-measurable disease : Non-measurable lesions are those th at are not suitabl e for quantitative assessment over time. These include: 1) Neoplastic masses that are too small to measur e, because their longest uninterrupted diameter or longest perpendicular are less than 10 mm. 2) Neoplastic masses whose boundaries cannot be distinguished. This includes masses which cannot be demarcated from surrounding tissue becau se of inadequate contrast, masses with overly complex morphology, or those with hi ghly heterogeneous tissue composition. 3) Other types of lesions that ar e confidently felt to represent ne oplastic tissue, but difficult to quantify in a reproducible manner. These in clude bone metastases, leptomeningeal metastases, malignant ascites, pleural/pericardi al effusions, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesi ons, ill-defined abdominal masses, etc. For irRC, only target lesions selected at base line and measurable new lesions are taken into account. At the baseline tumor assessment, the sum of the products of the two largest perpendicular diameters (SPD) of all index lesions (five lesions per organ, up to 10 visceral lesions and five cutaneous index lesions ) is calculated. At each subsequent tumor assessment, the SPD of the index lesions and of new, measurable lesions (≥ 5 X 5 mm; up to 5 new lesions per organ: 5 new cutaneous lesions and 10 visceral lesions) are added together to provide the total time-point tumor burden. Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 76Overall response using irRC:  Complete Response (irCR): Complete disappearance of all tumor lesions (whether measureable or not, and no new lesions). CR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented.