Rescue Medications and Supportive Care 5.7.1. Supportive Care Guidelines for Pembrolizumab Patients should receive appropriate supportive care measures as deemed necessary by the treating investigator. Suggested supportive care measures for the management of AEs with potential immunologic etiology are outlined along with the dose modification guidelines in Section 5.3.6.3, Table 5. Where appropriate, these guidelines include the use of oral or IV treatment with corticosteroids, as well as additional anti -inflammatory agents if symptoms do not improve with administration of corticosteroids. Note that several courses of steroid tapering may be necessary as symptoms may worsen when the steroid dose is decreased. For each disorder, attempts should be made to rule out other causes such as metastatic disease or bacterial or viral infection, which might require additional supportive care. The treatme nt guidelines are intended to be applied when the investigator determines the events to be related to pembrolizumab. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 171 Note: If after the evaluation of the event, it is determined not to be related to pembrolizumab, the Investigator does not need to follow the treatment guidance. Refer to Table 5 in Section 5.3.6.3.2, for guidelines regarding dose modification and supportive care. It may be necessary to perform conditional procedures such as bronchoscopy, endoscopy, or skin photography as part of evaluation of the event. 5.8. Diet/Activity/Other Considerations 5.8.1. Meals and Dietary Restrictions Participants should maintain a normal diet unless modifications are required to manage an AE such as diarrhea, nausea, or vomiting. 5.8.2. Contraception Galinpepimut-S and pembrolizumab may have adverse effects on a fetus in utero. Furthermore, it is not known if pembrolizumab has transient adverse effec ts on the composition of sperm. Please refer to Section 6.6 for further details. Participants should be informed that taking the study medication may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study. In order to participate in the study, participants of childbearing potential must adhere to the contraception requirement (from the day of study medication initiation (or 14 days prior to the initiation of study medication for oral contraception) throughout the study period up to 120 days after the last dose of study medication. If there is any question that a participant of childbearing potential will not reliably comply with the requirements for contraception, that participant should not be entered into the study. 5.8.3. Pregnancy If a participant inadvertently becomes pregnant while on treatment with either pembrolizumab or galinpepimut-S, the participant will be immediately discontinued from SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 172 study treatment. The site will contact the participant at least monthly and document the participant’s status until the pregnancy has been completed or terminated. The outcome of the pregnancy will be reported to the S ponsor without delay and within 24 hours if the outcome is a serious adverse experience (e.g., death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn). The study investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn to the Sponsor. 5.8.4. Nursing Women It is unknown whether one of the components of the investigational therapy, i.e., pembrolizumab is excreted in human milk. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the nursing infant, participants who are breastfeeding are not eligible for enrollment. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 173 6. Study Assessments and Procedures All patients must sign and date the informed consent before any study -specific procedures are performed. The study will be discussed with the patient and he or she will have the opportunity to have any questions answered before signing the ICF. The investigato r must address all questions raised by the patient. The investigator will also sign the ICF. The patient must also give authorization regarding privacy requirements before any study-related procedures. Each patient who provides informed consent and meets all of the inclusion criteria and none of the exclusion criteria at Day -3 (Baseline visit) will be enrolled using IWRS and will be assigned a 5-digit number that will be used on patient documentation throughout the stu dy. The first 2 digits of the number will refer to the site code and the last 3 digits will be a patient-specific number at that site. Patient numbers at each site will be assigned in ascending order and numbers will not be omitted or reused . Refer to Table 8 for the Schedule of Assessments. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 174 Table 8 Schedule of Assessments Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 Informed consent X Inclusion/ exclusion X X Tumor tissued X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 175 Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 Demographicse X Prior and concomitant medications X X X X X X X X X X X X X X Medical and surgical history X Physical examinationf X X ECOG X X X X X X X X X X Vital signg X X X X X X X X X X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 176 Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 Height X Weight X X X X X X X X X X Beta-hCG X X HIV testing X 12-lead ECG X PT, PTT, and INR X Hematologyh X X X X X X X X X Serum chemistryi X X X X X X X X X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 177 Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 TSH, FT4, and T3 or FT3 X X X X X X X X X Urine testj X X X X X X X X X HLA typingk X Cytogenetics and molecular analysis l X Bone Marrow biopsym X Xw X Xx Xy Xz X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 178 Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 Multigene MRD analysisn X X Xx Xy Xz X Immunologic Marker assessment o X Xw X Xaa Xy Xz X Biopsies of malignant tissue deposit p X X Xx Xt Xz X CT or MRIq X Xw X Xaa Xbb Xz X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 179 Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 Enrollment to studyr X GM-CSF SCs X X X X X X X X Assess local immunization site X X X X X Galinpepimut -St X Galinpepimut -S with pembrolizumab X X X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 180 Procedures Screenin g Period Open -Label Treatment Perioda Safety Follow -up Period Screening Baselineb Int. 2 WT1 - immunizing Inj (Q3 wk) Subsequent 4 WT1 - immunizing Inj (Q3 wk) Int. 1 Booster Inj Period - A (Q3 wk) 4 Series of Subsequent Intervals (2-4, 5-7, 8-10, and 11-13) Booster Inj Period – B (Q12 wk) Final Pem - brolizumab Mono - therapy Phase EOT/ETc Off-treatment Week 0, 3 6, 9, 12, 15 18 21, 24, 27, 30, 33, 36 [39, 42, 45], [51, 54, 57], [63, 66, 69], [75, 78, 81] 48, 60, 72, 84 87, 90, 93, 96, 99, 102, 105, and 108 30 days after last inj. Every 3 mnthsc Day(s) -28 to -4 −3b -2 1 -2 1 1 -2 1 1 -2 1 1 30-minute post injection observation X X X X X X X Pembrolizumab administration alone X X X X Adverse eventsu X X X X X X X X X X X X X X Evaluation of survivalv X X X X X X X X X SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 181 Abbreviations: ECG, electrocardiogram; ECOG, Eastern Cooperative Oncology Group; EOT, end of treatment; GM -CSF, granulocyte -macrophage colony - stimulating factor (sargramostim); INR, international normalized ratio; IV, intravenous; MRI, magnetic resonance imaging; MRD, minimal residual disease; mnths, months; PT, prothrombin time; PTT, partial thromboplastin time. a. To assess progression -free survival, relapse must be documented , and the following procedures performed: concomitant medicatio n, AEs, ECOG performance status, blood samples (hematology, serum chemistry, immune/exploratory correlates), and evaluation of clinical en dpoints. For AML patients that have relapsed, the relapse visit will also include BM aspiration. For non -progressors: At the time of progression/relapse documentation, an additional ‘relapse visit’ will be performed; refer to Section 6.1.5. b. At the baseline visit ( Day −3), all pretreatment screening procedures and assessments must be completed, review of inclusion/exclusion criteria (including specific tumor histologic type verification, [e.g., TNBC]), and review of laboratory and tissue pathology results confirmed prior to enrollment and the first GM -CSF injection. c. Patients who complete the study treatment period or patients who discontinue early (if they have received at least 1 treatmen t injection) will enter an off-treatment follow -up period to assess progression -free survival and overall survival. A follow -up phone call for serious adverse events will occur 90 days after the last dose of pembrolizumab OR 30 days following cessation of study treatment if the patient begins a new anticancer therapy, whichever is earlier. If the patient begins a new anticancer therapy, this must be reported by the investigator. If a patient is confirmed to have recurrent/refractory/relapsed disease after completion of a relapse visit, the patient is to return to the site within 30 d ays after their last treatment injection to complete EOT/early termination visit procedures. d. Retrieval of archival specimens (paraffin block sections) of tumor tissue (for solid tumors) or bone marrow (for AML) for WT1 IHC testing. Biopsy o f current tumor tissue (for solid tumors) or bone marrow (for AML) for WT1 IHC. For CRC only: additionally, collection of current tissue sample for microsatellite stability analysis. e. Demographics will include sex, age, race and ethnicity. f. Abnormal physical examination findings identified at the screening visit will be followed until resolution or stabilization. Any ongoing findings ( after study enrollment) should be recorded as pretreatment adverse events (AEs) and will be graded by Common Terminology Criteria f or Adverse Events (CTCAE), Version 5.0. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 182 g. Vital will include body temperature, systolic and diastolic blood pressure, heart rat e, and respiratory rate. h. The hematology assessment will include a complete blood count (CBC) with differential and platelet count. These samples will be collected for processing by the central laboratory. Samples must be collected before study treatment ad ministration. For abnormal complete blood count results, a manual differential is required. Specifically for AML patients, if the differential is suggestive of abnormal or immature cel ls and a possible relapse, a bone marrow biopsy must be performed as par t of a scheduled relapse visit. See the laboratory manual for more information.