Expected (known) adverse event: An advers e event, which has been reported in the Investigator’s Brochure. An adverse event is considered “expect ed”, only if it is included in the informed consent document as a risk. 6.4 Handling of Expedited Safety Reports In accordance with local regulations, the Sponsor will notify investigators of all SAEs that are unexpected (i.e. not previously de scribed in the Investigator Brochure), and definitely, probably, or po ssibly related to pembrolizumab, cyclophosphamide, or GVAX. This notification will be in the form of an expedited safety report (ESR) that is to be faxed to the investigators and the study coordinators within 48 hours. Upon receiving such notices, the investigator mu st review and retain the notice with the Investigator’s Brochure and wh ere required by local regulati ons, the investigator will submit the ESR to the appropriate IRB. The investigator and IRB will determine if the informed consent requires revision. The i nvestigator should also comply with the IRB procedures for reporting any othe r safety information. Where required, submission of ESRs by the investigator to Health Authorities should be handled according to local regulations. 6.5 Reporting 6.5.1 General All adverse events (both expected and unexpected) will be captured on the appropriate study-specific cas e report forms (CRFs). In addition, all serious adverse events, regardless of causality to study drug, will be reported promptly to the IND Sponsor (Dr. Lei Zheng, ) within 24 hours of recognition of the adverse event using the form found in Appendix D . If this falls on a weekend or holiday, an email notification is acceptable but must be followed by an SAE reporting form on the next business day. All serious adverse events, regardless of causality to study drug and/or administration will be forwarded to Merck’s Global Safety (“Merck GS”) group within 24 hours of l earning of the event. After the initial SAE report, the investigator is required to proactively follow each subject and provide further information to the safety department in regards to the subject’s condition. Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5 / January 17, 2018 40All SAE(s) will be followed until: • Resolution • Th e condition stabilizes • The event is otherwise explained • The subject is lost to follow-up Within 24 hours of receipt of follow-up information, a follow-up SAE report will be submitted to the IND Sponsor, Merck GS. Non-serious Events of Intere st will be forwarded to Me rck GS and will be handled in the same manner as SAEs. Although pregnancy and lactat ion are not considered ad verse events, it is the responsibility of investigators or their designees to report any pregnancy or lactation in a subject (spont aneously reported to them), including the pregnancy of a male subject's female partner who has provided written consent to provide information regarding pregnancy, that occu rs during the trial or within 120 days of completing the trial. All subjects who b ecome pregnant must be followed to the completion/termination of the pregnanc y. Pregnancy outcomes of spontaneous abortion, missed abortion, beni gn hydatidiform mole, blig hted ovum, fetal death, intrauterine death, miscarriag e and stillbirth must be reported as serious events (Important Medical Events). If the pregnancy continues to term, the outcome (health of infant) must also be reported to Merck GS. SAE reports and any other relevant safety information are to be forwarded to Merck GS facsimile number: . 6.5.2 Institutional Review Board (IRB) an d Institutional Biosafety Committee (IBC) All serious adverse events will be reported to the IRB and IBC per institutional standards. Follow-up information will be given to the IRB and IBC as soon as relevant information is available, per institutional standards. 6.5.3 Food and Drug Administration (FDA) All reporting to the FDA will be completed by the sponsor. 6.5.3.1 Expedited IND Safety Reports: 7 Calendar-Day Telephone or Fax Report : The Sponsor is required to notify the FDA of any fatal or life-threatening adverse event that is unexpected and asse ssed by the investigat or to be possibly related to the investigati onal agent. Such reports ar e to be telephoned or faxed ( to the FDA within 7 calendar days of first learning of the event. 15 Calendar-Day Written Report : The Sponsor is required to notify the FDA of any serious adverse event that is unexpected and possibly related to the i nvestigational agent in a written IND Safety Report. Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5 / January 17, 2018 41 Written IND Safety Reports should include an Analysis of Similar Events in accordance with regulation 21 CFR § 312.32. A ll safety reports previously filed with the IND concerning similar events should be analyzed.