A fine needle aspiration is not acceptable. Additional tissue collection and preparation procedures are provided in a separate Biopsy Manual . Heat Biologics, Inc. Viagenpumatucel -L Protocol HS110 -102 CONFIDENTIAL Amendment 6, 24 May 2019 Page 47 of 95 • Administration of HS-110 • Record AEs experienced by the patient • Record concomitant medications Week 12 , 14, 15, and 17 Assessments The following procedures will be performed at Week 12 (Day 7 8 ± 3), Week 14 (Day 9 2 ± 3), Week 15 (Day 9 9 ± 3), and Week 17 (Day 11 3 ± 3). • Vital signs, with abbreviated PE targeted to signs and symptoms (Week 15 only) • Administration of HS-110 • Administration of SOC nivolumab , per package insert (Weeks 15 and 17 only) • Record AEs experienced by the patient • Record concomitant medications 10.3. Arm 5: End of Treatment (EOT) Visit The following procedures should be completed approximately 3 to 4 weeks following last dose of HS-110, including patients who discontinue dosing prematurely. If patient completes all 18 weeks of HS-110 treatment, the EOT Visit should occur at Week 21 or 22. • Full PE (including height and weight) • Vital signs (blood pressure , heart rate , respiratory rate, and temperature) • Blood draw for IR (Section 14.2) • Blood draw for h ematology and serum chemistry (Section 13.2) • Record AEs experienced by the patient • Record concomitant medications 10.4. Arm 5: Follow -up Procedures Post-HS-110 Follow Up ( After HS -110 treatment until disease progression) The off -treatment follow -up period for Arm 5 is defined as the time when patients have discontinued or completed HS-110 treatment and are receiving SOC treatment with nivolumab monotherapy , which is administered per Investigator discretion according to the package insert dosing regimens of either every 2 weeks or every 4 weeks . During this time, radiological assessments will continue every 8 weeks until confirmation of iCPD by iRECIST . Any AEs deemed related to study drug will also be recorded. Survival Follow -Up (Progressive Disease until Death) The survival follow -up period refers to the time between the confirmation of PD and patient death. Patients will be followed for OS. Survival status and subsequent anti -cancer therapy will be Heat Biologics, Inc. Viagenpumatucel -L Protocol HS110 -102 CONFIDENTIAL Amendment 6, 24 May 2019 Page 48 of 95 collected approximately every 3 months in a clinic visit or by telephone if the patient is no longer attending clinic visits at the investigative site. 10.5. Arm 6: On Study Treatment Procedures Week 1 Assessmen ts (Day 1) The following procedures will be performed after all the previous Screening and Baseline procedures have been complete d, with HS -110 dosing beginning no later than the start of the 3rd maintenance treatment cycle, or more than 1 9 weeks from the start of front -line treatment for patients receiving pembrolizumab monotherapy: • Update of prior medications and pre -existing symptoms as medical history • Reconfirm eligibility prior to dosing • Blood draw for tumor mutation burden obtained prior to dosing (Section 14.6) • Blood draw for Troponin I or T levels obtained prior to dosing ( Section 13.4) • Administration of HS-110 • Monitor patients on site for potential acute reactions for 30 minutes after HS-110 administration (first dose only) • Administration of SOC pembrolizumab ± pemetrexed per package insert s • Record any AEs experienced by patient. • Record concomitant medications. Week 2 Assessments The following procedures will be performed at Week 2 (Day 8 ± 3): • Blood draw for Troponin I or T levels obtained prior to dosing (Section 13.4) • Vital signs, with abbreviated PE ( Section 13.1) targeted to signs and symptoms • Administration of HS-110 • Record AEs experienced by patient • Record concomitant medications Week 3 Assessments The following procedures will be performed at Week 3 (Day 15 ± 3): • Blood draw for Troponin I or T levels obtained prior to dosing ( Section 13.4) • ECG conducted prior to dosing • Vital signs, with abbreviated PE targeted to signs and symptoms • Administration of HS-110 Heat Biologics, Inc. Viagenpumatucel -L Protocol HS110 -102 CONFIDENTIAL Amendment 6, 24 May 2019 Page 49 of 95 • Record AEs experienced by patient • Record concomitant medications Week 4 Assessments The following procedures will be performed at Week 4 (Day 22 ± 3): • Blood draw for Troponin I or T levels obtained prior to dosing ( Section 13.4) • Blood draw for hematology and serum chemistry (Section 13.2) • Vital signs, with abbreviated PE targeted to signs and symptoms • Administration of HS-110 • Administration of SOC pembrolizumab ± pemetrexed per package insert s • Record AEs experienced by patie nt • Record concomitant medications Week 5, 6, 8, 9, 11 and 12 Assessments The following procedures will be performed at Week 5 (Day 29 ±3),Week 6 (Day 36 ± 3), Week 8 (Day 50 ± 3), Week 9 (Day 57 ± 3), Week 11 (Day 71 ±3) and at Week 12 (Day 78 ± 3): • Administration of HS-110 • Record AEs experienced by patient • Record concomitant medications • Week 9 only: Tumor assessment by CT scan or MRI and evaluation of tumor response using RECIST 1.1 and iRECIST ( Section 14.1.1 ) Week 7 and 13 Assessments The following procedures will be performed at Week 7 (Day 43 ± 3) and Week 13 (Day 85 ± 3): • Blood draw for immunological response obtained prior to dosing (Section 14.2) • Blood draw for hematology and serum chemistry (Section 13.2) • Vital signs, with abbreviated PE targeted to signs and symptoms (Week 7 only) • Administration of HS-110 • Administration of SOC pembrolizumab ± pemetrexed per package insert • Record AEs experienced by patient • Record concomitant medications Week 10 Assessments The following procedures will be performed at Week 10 (Day 64 ± 3): Heat Biologics, Inc. Viagenpumatucel -L Protocol HS110 -102 CONFIDENTIAL Amendment 6, 24 May 2019 Page 50 of 95 • Vital signs, with abbreviated PE targeted to signs and symptoms • Blood draw for hematology and serum chemistry (Sec tion 13.2) • Administration of HS-110 • Administration of SOC pembrolizumab ± pemetrexed per package insert • Record AEs experienced by patient • Record concomitant medic ations • Tumor biopsy collected when feasible unless written authorization from the Sponsor is obtained . Note that sample must be obtained via incisional, excisional or core needle biopsy.