Analysis Sets • The full analysis set (FAS) comprises all patients who are assigned to receive study treatment as per the ITT principle, regardless of whether or not they subsequently go on to receive study treatment or whether they deviate from the protocol in any major way. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 212 • The modified intent-to-treat (mITT) set comprises all patients who are assigned to receive study treatment and have at least 1 post -baseline efficacy assessment (RECIST 1.1), even if they deviate from the protocol in any major way. The mITT will also include any patient that goes off study treatment because of clinical progression prior to the first scheduled per-protocol scan. • The safety analysis set comprises all patients who receive any amount of study drug. • The per-protocol set (PPS) comprises all patients who are assigned to receive study treatment, receive at least 1 injection of study treatment, have at least 1 post -baseline efficacy assessment (RECIST 1.1), and do not deviate from the protocol in any major way. All efficacy analyses will be based on the FAS and will be conducted on the mITT set and PPS populations for exploratory purposes. For CRC patients, only those with MSS and MSI-L will be included in the efficacy primary analysis. The safety analyses will be based on the safety analysis set and will group patients according to treatment actually received. Secondary and exploratory efficacy analyses will be performed on the ITT/FAS as well as on the mITT and PPS populations for exploratory purposes . Major protocol deviations will be defined in mor e detail in the study statistical analysis plan (SAP), and may include, but not be limited to, incorrect diagnosis and poor compliance. All analyses using the PPS will group patients according to treatment actually received. 7.5.1. Prior Therapies All prior therapies used in the treatment of any of the tumor types under study will be collected from patients, including drug name, start and stop dates and treatment response. Data will be summarized in tables and presented in the listings. Descriptive statistics will be used to assess the impact of prior treatments on the efficacy endpoints . SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 213 7.6. Statistical Analysis Methodology Data will be summarized and/or analyzed by cohort.