3.3.2 Blinding The study subjects, investigators, study site personnel, including the pharmacist, safety laboratory personnel, central i maging readers, sponsor, and representatives of the sponsor involved in the conduct and/or management of the study will be blinded to treatment assignment. LV305 and its placebo will be identical in appearance; G305 and its placebos will be identical in appearance. All study treatments (CMB305 or placebo) will be labeled with the study number, a unique number, and any additional information required in accordance with government regulations. Further details will be contained in the Pharmacy Manual provided to study sites. The blind is only to be broken in cases of emergency where, upon documentation provided by investigator and verified by sponsor, immediate unblinding of the treatment is necessary in order to evaluate further course of action. For all cases requiring unblinding, the investigator is to contact the sponsor’s medical monitor or designee, per local country regulatory authority. 3.4 Study Assessments Safet y, tolerability and efficacy of CMB305 will be assessed during the study. The study will consis t of 5 periods: Pre -screening, Screening, Treatment, Post -treatment, and Long -term Follow -up. Pre-screening: subjects will attend a pre -screening visit within up to 151 days (Day -180 to Day -29) from the pre -screening informed consent form (ICF) . During the pre-screening period, subjects must still be receiving treatment with first- line systemic anti- cancer therapy , evaluate r adiographic disease response and take immunohistochemistry (IHC) test for the presence of NY -ESO -1. Once the investigator confirms 1) the subject has no evidence of progression (using RECIST v1.1) and 2) the IHC test results for NY -ESO -1 are positive (≥1% expression), then the Main Study ICF will be signed and subject will go to screening period. Screening : The d uration of the Screening period is 28 days (Day - 28 to Day -1) and begins on the date of the Main Study ICF was signed and ends at time of randomization. Subjects will undergo additional eligibility assessments and the investigator will confirm there is no evidence of progression (using RECIST v1.1) . Treatment : The Treatment period will begin on the day of randomization (Day 1), and continue until investigator -determined progressive disease (PD) (using RECIST v1.1), unacceptable toxicity, or 1 year after th e first dose, whichever occurs first. 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 13 / 36 Post-treatment : For subjects who discontinue study treatment for reasons other than disease progression, the post -treatment period will begin at the end of treatment and will continue until investigator -determined radi ographic PD (using RECIST v1.1) is documented. Long- term Follow -up: The Long -term Follow -up period will begin at the time investigator - determined PD (using RECIST v1.1) is documented and will continue for up to 5 years, until the date of death, or until sponsor notification of study closure. The detailed assessment plan is listed in table 1 and 2. Table 1 Schedule of Events for the Pre -Screening and Screening Periods Pre-Screening Perioda Screening Periodb Visit 1 2 Timeline – Day(s) Day-180 to Day -29 Day -28 to Day -1 Procedures Informed consent/assentc X X Obtain or collect tumor sample for IHC testing of NY-ESO -1 expressiond X Collect fresh tumor sample to assess tumor biomarkers (frozen and FFPE) at select U.S. sites X Investigator review of tumor response to first -line systemic anti -cancer therapy using RECIST v1.1e X Obtain images collected at the standard -of-care time point for the first evaluation of response to first -line systemic anti -cancer therapyf X Tumor imaging (CT/MRI) for baseline tumor response assessmentg X Inclusion and exclusion criteria X Demographics and medical history X Tumor -specific therapy history X Record prior and concomitant medications X Blood for chemistry laboratory testsh X Blood for hematology laboratory testsh X Blood for coagulation tests laboratory testsh X HIV, hepatitis B (HepB), and hepatitis C (HepC) testsh X Blood for anti -NY-ESO -1 plasma ELISAi X Blood for circulating tumor genomicsj X Urinalysish X Pregnancy testk X Vital sign measurementsl X Physical examinationm X 12-lead electrocardiogram X ECOG X QoL assessment X Blood for LV305 persistence X CT = computed tomography; ECOG = Eastern Cooperative Oncology Group; ELISA = Enzyme -linked immunosorbent assay; HIV = human immunodeficiency virus; ICF = informed consent form; IHC = 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 14 / 36 immunohistochemistry; MRI = magnetic resonance imaging; NY -ESO -1 = New Yo rk esophageal squamous cell carcinoma -1; QoL = quality of life; RECIST = Response Evaluation Criteria in Solid Tumors a The Pre -screening period is up to 151 days (Day -180 to Day - 29) and is the time from the subject and/or their legally authorized representative signing the Pre -screening ICF/assent form to the time of signing the Main study ICF/assent form. The Pre- Screening can commence at any time after first dose of first -line systemic anti -cancer therapy. b The duration of the Screening period is 28 days (Day -28 to Day -1) and begins on the date the subject and/or their legally authorized representative sign the Main study ICF/assent form. At Day 1, subjects must have documented completion of first -line systemic anti -cancer therapy and must have received at least 4 to 8 cycles of therapy (or no more than 180 days of systemic anti -cancer therapy). c Two informed consents (subjects aged ≥18 years and legally authorized representatives of subjects aged 12 to <18 years) or assents (subjects aged 12 to <1 8 years) will be used in this study. The Pre -screening ICF/assent form will allow for IHC testing of the tumor sample (fresh or archival) for the presence of NY -ESO -1 and review of the tumor images (CT or MRI) collected before administration of the first d ose of first -line systemic anti -cancer therapy and at the subsequent standard -of-care time point for the first evaluation of response to first -line systemic anti -cancer therapy. The Main study ICF/assent must be signed before any Screening study -related pr ocedures are initiated. Before the Main study ICF/assent can be signed, results of IHC testing for the presence of NY -ESO -1 (≥1% expression) must be available from the central laboratory, and the investigator -evaluated tumor response (using RECIST v1.1) to first-line systemic anti -cancer therapy must be documented. d At Pre -screening, a tumor sample (fresh or archival) will be collected or obtained for the IHC testing by the central laboratory for the presence of NY -ESO -1 expression (≥1% expression). Archi val tumor tissue or fresh tumor tissue will be obtained from a biopsy or a resected tumor lesion, as appropriate (tumor tissue may be from a sample obtained within 18 months before signing the Pre -screening ICF/assent form). e Obtain images (CT or MRI) co llected before administration of the first dose of first- line systemic anti -cancer therapy. Images will be assessed by the investigator using RECIST v1.1. Investigator assessment of all target and non-target lesions and tumor response assessment will be captured in the eCRF. Subjects who have a tumor response of stable disease with evidence of ≥15% to 20% increase in tumor burden will be submitted for central review to adjudicate the investigator’s assessment of tumor response prior to randomization. f Obtain and review images (CT or MRI) collected at the standard -of-care time point for the first evaluation of response to first -line systemic anti -cancer therapy. The subject’s response to first -line systemic anti -cancer therapy will be assessed by the invest igator using RECIST v1.1 and documented in the eCRF. g Tumor imaging (CT or MRI) will be performed after completion of the planned 4- cycles to 8 -cycles of first -line systemic anti -cancer therapy for the evaluation of response at baseline, as assessed by t he investigator using RECIST v1.1. The images collected at this time point will serve as the baseline assessment for the efficacy evaluations. These images must be collected within 28 days after the date of last dose of first -line systemic anti - cancer ther apy. h Results from the central laboratory will be used to determine eligibility and for the safety analysis. Laboratory tests performed by the central laboratory will include: chemistry with liver function tests, lactate dehydrogenase, alkaline phosphata se, albumin, hematology with complete blood count with differential, HIV, HepB, and HepC. Coagulation samples will be drawn only at Screening and shipped to the central laboratory (prothrombin time, partial thromboplastin time, and international normalized ratio) for analysis. Urinalysis will be conducted at the central laboratory. All laboratory assessments to be performed are listed in protocol Table 4. i The peripheral blood on all subjects must be collected Day -28 to Day -7 during Screening and will b e used for plasma ELISA testing; results of the assessment will be used for stratification and randomization. j For circulating tumor genomics, please see lab manual. k For FCBP, serum pregnancy testing will be performed during Screening. l Vital sign measurements will include body temperature, heart rate, respiratory rate, and resting systolic and diastolic blood pressure. m At Screening, the physical examination should include an evaluation of organ systems, including, but not limited to, head and neck; chest and lungs; cardiac; gastrointestinal; neurologic; endocrine; and musculoskeletal and integument. Other organ systems should be evaluated as direc ted by medical history or current symptoms.