13.5. Pregnancy All female patients of childbearing potential will have a urine or serum pregnancy test performed at the Screening and Baseline Visits. Female patients who become pregnant during the study should discontinue study medication immediately. The patient will receive counseling from the Investigator or designee regarding the nature of the study medication and the potential risk on fetal development. Time Period for Collecting Pregnancy Information All pregnancy information should be collected from the time of Screening Visit (up to Day -28 prior to study drug a dministration ) to 4 weeks after the last dose of study medication. Patients with pregnancies identified during screening will be recorded as screen failures. Action to be Taken if Pregnancy Occurs The Investigator will notify the Sponsor, or designee, within 24 hours of learning of a patient’s pregnancy. The patient will also be followed to determine the outcome of the pregnancy. Information on the status of the mother and child wil l be forwarded to the Sponsor, or designee. Generally, follow -up will be no longer than 6 to 8 weeks following the estimated delivery date. Any premature termination of the pregnancy will be reported. While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or elective termination of a pregnancy for medical reasons w ill be recorded a s an AE or SAE (see AE and SAE Section 15.1). A spont aneous abortion after the first trimester will be reported as an SAE. Furthermore, any SAE occurring as a result of a post -study pregnancy and that is considered reasonably related to the study drug by the Investigator will be reported to the Sponsor. Whil e the Investigator is not obligated to actively seek this information in former study participants, he or she may learn of an SAE through spontaneous reporting. Action to be Taken if Pregnancy Occurs in a Female Partner of a Male Study Subject The Investig ator will attempt to collect pregnancy information on any male study patient’s female partner who becomes pregnant while participating in this study. The Investigator will record pregnancy information on the appropriate form and submit it to the Sponsor, o r designee, within 24 hours of learning of the partner’s pregnancy. The partner will also be followed to determine the outcome of the pregnancy. Information on the status of the mother and child will be forwarded to the Sponsor or designee. Generally, follow -up will be no longer than 6 to 8 weeks following the estimated delivery date. Any premature termination of the pregnancy will be reported. Heat Biologics, Inc. Viagenpumatucel -L Protocol HS110 -102 CONFIDENTIAL Amendment 6, 24 May 2019 Page 62 of 95 14. ASSESSMENT OF EFFICA CY 14.1. Tumor Assessments Tumor response assessments will incorporate results from radiographic tumor assessment (CT scans or MRI) of the chest, abdomen, and pelvis as well as physical examination, where appropriate, and will follow RECIST 1.1 and iRECIST criteria. PET scans will a lso be collected if obtained but are not required per protocol. The identification of target plus non -target lesions by CT or MRI will be documented at Screening , and repeat scans will be performed at Week 9, Week 18 and then every 8 weeks thereafter (Arm 5), or at Screening and every 9 weeks (Arm 6) until confirmed iCPD per iRECIST , unless clinical signs of progression necessitate earlier scanning. The same method used at Screening must be used throughout the study whenever possible . Bone scans are NOT acceptable for determination of disease status, and suspected bone lesions must be confirmed by CT/MRI. PET scanning is strongly discouraged for the purposes of disease evaluation, and any proposed use should be discussed with the Medical Monitor prior to baseline scanning. RECIST 1.1 and iRECIST for Tumor Assessment At the baseline tumor assessment, tumor lesions/lymph nodes will be categorized as measurable or non -measurable with measurable tumor lesions recorded according to the longest diameter in the p lane of measurement (except for pathological lymph nodes, which are measured in the shortest axis). When more than 1 measurable lesion is present at baseline, all lesions up to a maximum of 5 lesions total (and a maximum of 2 lesions per organ) representat ive of all involved organs should be identified as target lesions. For the purposes of this study, a maximum of 2 lymph nodes are permitted as target lesions, irrespective of the organ systems from which they originate. Target lesions should be selected on the basis of their size (lesions with the longest diameter). A sum of the diameters for all target lesions will be calculated and reported as the baseline sum diameters. Radiographic assessment (CT scan or MRI) will be performed as follows: Arm 5: Screen ing, W eek 9, Week 18, and every 8 weeks thereafter until confirmed disease progression; Arm 6: Screening and e very 9 weeks until confirmed disease progression All other lesions (or sites of disease), including pathological lymph nodes, should be identified as non-target lesions and should also be recorded at baseline. Measurements are not required and these lesions should be followed as ‘present ,’ ‘absent ,’ or ‘unequivocal progression .’ Disease response via RECIST 1.1 and iRECIST will be assessed as outlined in Appendix 3. The determination of iRECIST response uses the same guidelines to determine measurable or non - measurable lesions. The concept cha nge for iRECIST is the resetting of the bar if RECIST 1.1 progression is followed at the next assessment by tumor shrinkage . This approach allows atypical responses, such as delayed responses that occur after pseudoprogression, to be identified, further understood, and better characterized.