Additionally , During the global pandemic of COVID -19, if a pat ient has missed 2 or more tumor assessments for causes related to COVID- 19(if the causes were identifiable and verified from an y source ), the patient may not be censored at the last objective tumor assessment, and the subsequent available tumor assessments can be used to determine an event of disease progression or as the censoring point. Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 3010.4. Appendix: Immune -related Response Criteria per RECIST 1.1 (irRECIST) Immune -related progressive disease (irPD) needs to be confirmed b y a second, consecutive assessment at least 4 weeks apart. irPD is also considered to be confir med if the patient . dies within 12 weeks after the initial observation of irPD, or discontinues treatment due to disease progression (clinical deterioration without radiological documentation) prior to or within 12 weeks after the assessment of irPD. Imm une-related Best Overall Response (irBOR) will be derived based on reported lesion responses at different evaluation time points from the start date until confirmed immune -related disease progression per irRECIST, according to the following rules . Confirme d irCR = at least two determinations of irCR at least 4 weeks apart before irPD . Unconfirmed irCR = one determination of irCR before irPD (and not qualify ing for confirmed irCR or irPR) . Confirmed irPR = at least two determinations of irPR or better at least 4 weeks apart before irPD (and not qualify ing for confirmed irCR) . Unconfirmed irPR = one determination of irPR before irPD (and not qualify ing for confirmed irCR or irPR or unconfirmed irCR) . irSD = at least one irSD or irPD assessment  6weeks after start date and before confirmed irPD (and not qualify ing for confirmed/unconfirmed irCR or irPR). irPD = ≤ 12 weeks after the first dose of stud y treatment and at least two consecutive determinatio ns of irPD at least 4 weeks apart. irPD is also considered to be confirmed if the patient . dies within 12 weeks after the initial observation of irPD, or discontinues treatment due to disease progression (clinical deterioration without radiological documentation) prior to or within 12 weeks after the assessment of irPD. NE: All other cases . Only tumor assessments performed before the start of any further anti -cancer treatment will be considered in the assessment of irBOR. Immune -related Objective R esponse (irOR) is defined as irCR or irPR according to irRECI ST from start date until confirmed irPD or death due to an y cause. Both irCR and irPR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for immune-related response are first met. Also, irPD must be confirmed by a Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 31second, consecutive assessment at least 4 weeks apart. Immune-related OR rate (irORR) is the proportion of patients with irOR in the analysis set. Immune-relate DC rate (irDCR) is the proportion of patients with irDC. Immune-related Duration of Response (irDR) is defined, for patients with an immune-related objective response, as the time from first documentation of immune-related objective response (irCR or irPR) to the date of first documentation of irPD (which is subsequently confirmed) or death due to any cause. If a patient has not had an event (irPD or death), irDR is censored at the date of last adequate tumor assessment. The censoring rules for irDR are as described below for irPFS. irDR (months) = [date of event or censoring– first date of irOR +1]/30.4375 Immune-related Time to response (irTTR) is defined, for patients with an irOR, as the time from the start date to the first documentation of immune-related objective tumor response (irCR or irPR) which is subsequently confirmed. irTTR (in months) = [first date of irOR – start date +1]/30.4375 Immune-related Progression-Free Survival (irPFS) is defined as the time from start date to the date of irPD or death due to any cause, whichever occurs first. irPFS data will be censored on the date of the last adequate tumor assessment for patients who do not have an event (confirmed irPD or death), for patients who start a new anti-cancer therapy prior to an event or for patients with an event after two or more missing tumor assessments. Patients who do not have a baseline tumor assessment or who do not have any post-baseline tumor assessments will be censored on the start date unless death occurred on or before the time of the second planned tumor assessment in which case the death will be considered an event. The censoring and event date options to be considered for the irPFS and irDR analysis are presented in Table 2 . CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 32Table 2. Outcome and Event Dates for irPFS and irDR Analyses Scenario Date of event/censoring Outcome No baseline assessment Start date Censored a irPD (subsequently confirmed) or death 16weeks after last tumor assessment or 16weeks after start dateDate of first irPD or death Eventb irPD (subsequently confirmed) or death > 16weeks after the last tumor assessment Date of last adequate assessment Censored Treatment discontinuation due to ‘Disease progression’ (clinical deterioration without radiological documentati on) prior to or within 12weeks after the assessment of first irPDDate of first irPD Event New anti-cancer therapy prior to confirmed irPD Date of last adequate assessment before anti -cancer therapy is givenCensored irPD not confirmed or no irPD Date of last adequate assessment Censored aHowever if the patient dies 8weeks after start date the death is an event with date on death date b irPD is also considered to be confirmed if the patient dies within 12 weeks after the initial documentation of irPD The anal yses for irBOR, irOR, irDR, irDC, irTTR will follow the methodology outlined for the RECI ST 1.1 endpoints as follows irOR will be summarized but no formal test of h ypotheses will be performed (only 95% CIs will be reported) irBOR, irOR, irDC, irDR, irTTR and irPFS will be summarized as described in Sections xx, for RECI ST endpoints but irDR and irPFS will be anal yzed using the censor ing rules described in Table 2.