A Phase II Evaluation of ADXS11-001 (NSC 752718) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix
Phase: PHASE2
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma
Sponsor: Gynecologic Oncology Group

Philip J. DiSaia, M.D. 
President 
 
Administrative Office 
Four Penn Center 
1600 John F. Kennedy Boulevard, Suite 1020 
Philadelphia, Pennsylvania 19103 
Phone: 215-854-0770 Fax: 215-854-0716 
 
Laura L. Reese 
Executive Director of Operations 
 
Larry J. Copeland, M.D. 
Vice President  
 
Finance/Development Office 
2127 Espey Court 
Suite 100 
Crofton, Maryland 21114 
Phone: 410-721-7126 Fax: 301-261-3972 
 
Mary C. Sharp 
Chief Financial Officer 
 
 
i
TO:   ALL PRINCIPAL INVESTIGATORS/NURSES/DATA MANAGERS 
 
FROM: 
MEG COLAHAN 
PROTOCOL SECTION 
 
DATE: 
OCTOBER 18, 2016 
 
RE: 
PROTOCOL GOG-0265 – CLOSURE 
 
 
Protocol Title:  “A Phase II Evaluation of ADXS11-001 (NSC 752718, BB-IND #13,712) in 
the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of 
the Cervix” 
 
Study Chair: Warner K. Huh, M.D.; (205) 934-4986; email: whuh@uabmc.edu 
 
 
Effective October 24, 2016, GOG-0265 is closed to patient entry.  
 
The GOG Foundation and Advaxis, Inc. have agreed to close GOG-0265 to patient entry.  This 
decision was at the request of the Sponsor (Advaxis): GOG-0265 was previously placed on a 
FDA clinical hold, and subsequent review of Stage 2 data was consistent with Stage 1; a phase 
III study of the agent has already been initiated. 
 
Follow-up of patients already entered onto GOG-0265 will continue per protocol. 
 
Members of the study team will be reaching out to you soon to discuss next steps for closing out 
the study. 
 
SUMMARY OF CHANGES 
 
NCI Protocol #: GOG-0265 
Local Protocol #: GOG-0265 
 
NCI Version Date: 05/20/2016 
Protocol Date: 06/27/2016 
 
# 
Section(s) 
Page(s) 
Change 
1 
Title Page 
1 
 
To reflect the date of closure.  
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 1 - 
 
PROTOCOL GOG-0265 
A PHASE II EVALUATION OF ADXS11-001 (NSC 752718, BB-IND#13,712) IN THE 
TREATMENT OF PERSISTENT OR RECURRENT SQUAMOUS OR NON-SQUAMOUS 
CELL CARCINOMA OF THE CERVIX 
NCI Version Date:  05/20/2016 
Includes Amendments #1-13 
POINTS: 
PER CAPITA- 20 
MEMBERSHIP- 6 (10/22/2012) 
TR PER CAPITA – Award based on specimen submission with 1.0 point for FFPE and 1.0 point for each 
serum specimen (MAX = 13 points). (05/06/2013) 
Lead Organization: NRG/NRG Oncology (02/02/2015) 
STUDY CHAIR  
 
 
 
 
PHASE I SAFETY LEAD-IN CHAIR (10/22/2012) 
WARNER K. HUH, MD  
 
 
 
DON DIZON, MD 
UNIVERSITY OF ALABAMA AT BIRMINGHAM  
MASSACHUSETTS GENERAL HOSPITAL 
DEPARTMENT OF OB/GYN 
 
 
 
GYN ONCOLOGY 
618 20TH STREET SOUTH, 538 OHB 
 
 
55 FRUIT STREET, YAWKEY, 9E 
BIRMINGHAM, AL 35233 
 
 
 
BOSTON, MA 02114 
(205) 934-4986  
 
 
 
 
(617) 724-4800 
FAX: (205) 975-6174 
 
 
 
 
FAX: (617)724-6898 
EMAIL: warner.huh@ccc.uab.edu 
 
 
EMAIL: ddizon@partners.org  
 
STATISTICIAN  
 
 
 
 
STUDY CO-CHAIR (06/27/2016) 
WILLIAM E. BRADY, PhD 
 
CAROL AGHAJANIAN, MD 
SEE GOG WEBSITE DIRECTORY 
SEE GOG WEBSITE DIRECTORY 
 
NURSE CONTACT (02/06/2012) (12/23/2013) 
 
TRANS. RESEARCH CHAIR 
TERRY SIRLES, RN, BSN  
 
 
 
KUNLE ODUNSI, M.D. 
UNIVERSITY OF ALABAMA AT BIRMINGHAM 
SEE GOG WEBSITE DIRECTORY 
GYNECOLOGIC ONCOLOGY 
619 19TH STREET SOUTH 
 
 
 
BIRMINGHAM, AL 35249-7333  
 
 
TRANS. RESEARCH SCIENTIST 
(205) 934- 
HEATHER A. LANKES, PhD, MPH 
FAX: (205) 975-9769  
SEE GOG WEBSITE DIRECTORY 
EMAIL:  tsirles@uabmc.edu 
 
 
 
 
 
 
 
 
OPEN TO PATIENT ENTRY MAY 23, 2011; REVISED OCTOBER 17, 2011; REVISED FEBRUARY 6, 2012; 
REVISED OCTOBER 22, 2012; REVISED AND OPEN TO PATIENT ENTRY GROUP WIDE MAY 6, 2013; 
REVISED DECEMBER 23, 2013; TEMPORARILY CLOSED TO PATIENT ENTRY MAY 5, 2014; 
REVISED AND REOPENED TO PATIENT ENTRY FEBRUARY 2, 2015; REVISED MARCH 9, 2015; 
REVISED JUNE 27, 2016; CLOSED TO PATIENT ENTRY OCTOBER 24, 2016 
 
SCHEMA  (12/23/2013) (03/09/2015) (06/27/2016) 
ADXS11-001 will be given once every 28 days (60 minute intravenous infusion of 1 x 109 cfu in 250 
ml of normal saline) until disease progression or adverse events prohibit further therapy. 
This protocol was designed and developed by the Gynecologic Oncology Group (GOG). It is intended to be used 
only in conjunction with institution-specific IRB approval for study entry. No other use or reproduction is authorized 
by GOG nor does GOG assume any responsibility for unauthorized use of this protocol. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 2 - 
 
TABLE OF CONTENTS 
PAGE 
1.0 OBJECTIVES 
- 5 - 
1.1 Primary Objectives 
- 5 - 
1.2 Secondary Objectives 
- 5 - 
1.3 Exploratory Objectives 
- 5 - 
2.0 BACKGROUND AND RATIONALE 
- 5 - 
2.1 Cervical Cancer and Its Relationship to the Human Papillomavirus (HPV) (06/27/2016) - 5 - 
2.2 HPV Vaccines 
- 7 - 
2.3 Recombinant Listeria monocytogenes (Lm) as a Vaccine Vector 
- 9 - 
2.4  
Listeria monocytogenes Expressing HPV 16-E7 (ADXS11-001 Immunotherapy) 
(06/27/2016) 
- 10 - 
2.5 ADXS11-001 Mechanism of Action (06/27/2016) 
- 10 - 
2.6 Summary of Previous Clinical Studies (06/27/2016) 
- 11 - 
2.7 Summary of Safety of ADXS11-001 (06/27/2016) 
- 13 - 
2.8 Rationale for Survival Endpoint and Confirmation of Progression (5/23/2011) 
- 16 - 
2.9 Rationale for restricting enrollment to patients who have received only one prior 
chemotherapy regimen (12/23/2013) (06/27/2016) 
- 17 - 
2.10 
Rationale for Additional Treatment Cycles (03/09/2015) 
- 17 - 
2.11 
Inclusion of Women and Minorities (12/23/2013) 
- 19 - 
3.0 PATIENT ELIGIBILITY AND EXCLUSIONS 
- 19 - 
3.1 Eligible Patients 
- 19 - 
3.2 Ineligible Patients 
- 21 - 
4.0 STUDY MODALITIES 
- 23 - 
4.1 ADXS11-001 (IND #13,712) 
- 23 - 
4.2 Pathology Requirements 
- 32 - 
5.0 TREATMENT PLAN AND ENTRY/REGISTRATION PROCEDURE 
- 33 - 
5.1 Patient Entry and Registration 
- 34 - 
5.2 Treatment Plan (06/27/2016) 
- 34 - 
5.3 Dose Limiting Toxicities FOR PHASE I SAFETY LEAD_IN PORTION ONLY 
(06/27/2016) 
- 38 - 
5.4 Concurrent Therapies and Procedures (06/27/2016) 
- 39 - 
6.0 TREATMENT MODIFICATIONS AND SUPPORTIVE CARE (5/23/2011) (06/27/2016) - 
41 - 
6.1 Additional Guidelines for the Management of Hematologic Toxicity (06/27/2016) 
- 41 - 
6.2 Supportive Care Guidelines (06/27/2016) 
- 42 - 
6.3 Listeriosis and Listeria Infection – Identification and Management (06/27/2016) 
- 49 - 
6.4 Major and Minor Surgeries and ADXS11-001 Treatment (06/27/2016) 
- 51 - 
7.0 STUDY PARAMETERS 
- 52 - 
7.1 Observations and Tests 
- 52 - 
7.2 Pathology Requirements: (02/06/2012) 
- 53 - 
7.3  
Translational Research 
- 53 - 
7.4 Quality of Life 
- 55 - 
8.0 EVALUATION CRITERIA 
- 56 - 
8.1 Antitumor Effect – Solid Tumors (10/22/2012) 
- 56 - 
8.2 Response Assessment:  Immune-Related RECIST (10/22/2012) 
- 62 - 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 3 - 
 
8.3 Duration of Response (10/22/2012) 
- 65 - 
8.4 Recurrence (10/22/2012) 
- 66 - 
8.5 Recurrence-Free Survival (10/22/2012) 
- 66 - 
8.6 Progression-Free Survival (10/22/2012) 
- 66 - 
8.7 Survival (10/22/2012) 
- 66 - 
9.0 DURATION OF STUDY 
- 67 - 
9.1 Patients will continue treatment until disease has progressed and been confirmed or 
progressed in the setting of clinical deterioration or intolerable toxicity intervenes.  The 
patient can refuse the study treatment at any time. (5/23/2011) (03/09/2015) 
- 67 - 
9.2 Patients will be followed (with physical exams and histories) every three months for the first 
three years and then every six months for the next two years.  Patients will be monitored for 
delayed toxicity and survival for this 5 year period with Q forms submitted to the GOG 
Statistical and Data Center, unless consent is withdrawn. (5/23/2011) (06/27/2016) 
- 67 - 
10.0 
STUDY MONITORING AND REPORTING PROCEDURES 
- 68 - 
10.1 
IND Sponsor: Advaxis Inc., IND #13,712 
- 68 - 
10.2 
ADVERSE EVENT REPORTING FOR AN INVESTIGATIONAL AGENT 
- 68 - 
10.3 
GOG DATA MANAGEMENT FORMS 
- 74 - 
11.0 
STATISTICAL CONSIDERATIONS 
- 76 - 
11.1 
This is a single-arm, two-stage Phase II study, and no randomization is involved; 
however, patient registration will be accomplished in the usual fashion. For patients in the 
safety lead-in, patient entry will be accomplished via the GOG Statistical and Data Center’s 
Phase I reservation and registration system. 
- 76 - 
11.2 
The principle parameters to be employed to evaluate the primary and secondary 
objectives are: 
- 76 - 
11.3 
Of the 25 patients enrolled in stage 2 11 patients were still on treatment at the time the 
clinical hold went into effect. It is clear that the latter patients should be replaced because 
they did not receive treatment per protocol (i.e., until progression).  However, including just 
patients who had progressed or died or who had otherwise come off study treatment, while 
excluding patients still on treatment at the time of the clinical hold, would introduce bias into 
the assessment of the efficacy of the study treatment.  Therefore, all patients enrolled in 
stage 2 prior to the clinical hold will be excluded from efficacy analyses and will be 
replaced.  All treated patients will be included in all safety analyses. (5/23/2011) 
(06/27/2016) 
- 76 - 
11.4 
The study plan is a single arm, 2-stage phase II clinical trial.  The study also includes a 
safety lead-in, in which the dose limiting toxicities of the study agent will be assessed in the 
first 6 patients enrolled. 
- 77 - 
11.5 
Evaluability for efficacy and toxicity 
- 83 - 
11.6 
Data Safety and Monitoring 
- 83 - 
11.7 
Secondary and Exploratory Analyses 
- 84 - 
11.8 
Anticipated Gender and Minority Inclusion (5/23/2011) 
- 85 - 
12.0 
BIBLIOGRAPHY 
- 86 - 
APPENDIX I – TRANSLATIONAL RESEARCH SPECIMEN PROCEDURES (05/06/2013) 
(06/27/2016) 
- 91 - 
APPENDIX II-  PATIENT DRUG CALENDAR – NAPROXEN or IBUPROFEN 
- 97 - 
(12/23/2013) (06/27/2016) 
- 97 - 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 4 - 
 
APPENDIX III - PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) REGULAR STRENGTH 
(12/23/2013) (06/27/2016) 
- 98 - 
APPENDIX IV - PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) DOUBLE STRENGTH (DS) 
(06/27/2016) 
- 99 - 
APPENDIX V - PATIENT DRUG CALENDAR – AMPICILLIN (06/27/2016) 
- 100 - 
APPENDIX VI – Post Study Treatment PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE  (BACTRIM) REGULAR STRENGTH 
(06/27/2016) 
- 101 - 
APPENDIX VII -Post Study Treatment PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) DOUBLE STRENGTH 
(06/27/2016) 
- 104 - 
APPENDIX VIII – Post Study Treatment PATIENT DRUG CALENDAR –AMPICILLIN - 107 - 
APPENDIX IX - GOG GENERAL CHEMOTHERAPY GUIDELINES 
- 113 - 
(06/27/2016) 
- 113 - 
 
 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 5 - 
 
1.0 
OBJECTIVES  
 
1.1 
Primary Objectives 
 
1.1.1 To evaluate the tolerability, safety and nature and degree of toxicity of ADXS11-001 by 
the numbers of patients with dose limiting toxicities (DLTs) and adverse events as 
assessed by the CTCAE v4.0. (12/23/2013) 
 
1.1.2 To assess the activity of ADXS11-001 for patients with persistent or recurrent carcinoma 
of the cervix with the frequency of patients who survive for at least 12 months after 
initiating therapy. 
 
1.2 
Secondary Objectives 
 
1.2.1  To characterize the distribution of progression-free survival and overall survival. 
 
1.2.2  To examine the proportion of patients with objective tumor response. 
 
1.3 
Exploratory Objectives 
 
1.3.1 To assess changes in clinical immunology based upon serum cytokines and to correlate 
any observed changes with clinical response including progression-free survival, overall 
survival, tumor response, DLTs and adverse effects. 
 
1.3.2 To examine associations between presence and type of high-risk human papillomavirus 
(H-HPV) and measures of clinical response and serum cytokine levels. 
2.0 
BACKGROUND AND RATIONALE 
 
2.1 
Cervical Cancer and Its Relationship to the Human Papillomavirus (HPV) (06/27/2016) 
 
Cervical cancer is the fourth most common cancer and the most common cause of 
mortality in women worldwide with 528,000 new cases reported annually, and an 
estimated 266,000 deaths in 2012.1  Worldwide, over half a million women are diagnosed 
with cervical cancer each year, predominantly in under-developed countries, where most 
cases present at an advanced stage due to lack of effective cervical cancer screening 
systems.2  In the United States (US), it is estimated that 12,340 women were diagnosed 
with cancer of the cervix, and 4,030 women died of the disease in 2013.3 
The human papilloma virus (HPV) is now recognized to be the primary etiologic agent 
for cervical carcinogenesis, and cervical cancer is the first cancer recognized by the 
World Health Organization to be 100% attributable to an infection with high-risk HPV 
genotypes.2  However, the majority of HPV-infected individuals have an asymptomatic 
course, with clearance of the virus occurring within 1 or 2 years in 90% of cases.  Ten 
percent of individuals experience persistent HPV infection, which increases their risk of 
developing invasive cancers.  Ultimately, approximately one-half of the 10% of 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 6 - 
 
individuals with persistent HPV infection will develop malignant disease, a process that 
may take up to 30 years.4 
Although many HPV types have been associated with cervical neoplasia, types 16, 18, 
31, 35, 39, 45, 51, 52, 56, and 58 cause most invasive cancers and are considered “high-
risk” HPV-genotypes.  HPV-16 accounts for approximately 53% of invasive cervical 
cancer (ICC) cases in most countries, followed by HPV-18, which accounts for 
approximately 13%.5  The high-risk HPV genotypes produce 2 oncoproteins, designated 
E6 and E7, which bind and inactivate the tumor suppressor’s p53 and retinoblastoma 
protein (pRB), respectively.  The E6 mediated inhibition of p53 blocks apoptosis, 
whereas E7 inhibition of pRB abrogates cell cycle arrest leading to deregulated cellular 
proliferation and ultimately malignancy.5 
Persistent HPV infection may lead initially to abnormal changes in cervical cells, termed 
cervical dysplasia or cervical intraepithelial neoplasia (CIN).  However, CIN is a distinct 
clinic pathological entity from ICC and defines premalignant lesions (namely CIN 2/3) 
that, if left untreated, may eventually progress to ICC.  However, these lesions have a 
high rate of spontaneous remission and can be curatively treated with a minor 
gynecologic surgical procedure such as loop electrical electrosurgical procedure or a cone 
biopsy. 
In the US, most cases of ICC are detected at early stages because of the implementation 
of cervical cancer screening programs.  Staging of ICC is usually based on the American 
Joint Committee on Cancer or the International Federation of Gynecology and Obstetrics 
system, which are similar.  Approximately 60% of ICC cases are diagnosed at stage I, 
25% at stage II, 10% at stage III, and 5% at stage IV.6  Standard treatments for ICC 
include surgery, radiation alone, chemotherapy alone, or combination 
radiation/chemotherapy.  Surgery and radiation therapy are considered to be equally 
effective for early-stage, small-volume disease.  For more advanced disease, that is not 
reliably curable by surgery, additional treatments including radiation and potentially 
systemic chemotherapy are required.  Several clinical trials have shown an overall 
survival advantage with cisplatin concurrent with radiation therapy (chemoradiation), and 
chemoradiation with cisplatin is the currently recommended treatment for locally 
advanced cervical cancer.7  Platinum doublet chemotherapy with or without bevacizumab 
is currently recommended as standard of care for patients with recurrent or primary 
metastatic (stage IVB) cervical cancer that is not amenable to surgery or radiation.7 In 
general, survival correlates with stage, with a 5-year survival for stage IA of almost 
100%, stage IB2 and IIB 50%–75%, stage III 30%-50%, and stage IV 15%.  For locally 
recurrent disease, pelvic exenteration can lead to a 5-year survival rate of 32%-62% in 
selected patients.7  Although most cases of early-stage cervical cancer can be cured, 
treatments are associated with significant long-term morbidity7 and most have an impact 
on fertility.  Cisplatin, the most commonly used and most active therapy, has produced 
response rates ranging from 20%-30% and overall survival of less than 10 months.8 In 
addition, patients with recurrent disease will typically have already received cisplatin 
concurrent with radiotherapy as a first-line therapy, and may no longer be sensitive to 
cisplatin.9[9]  In view of the low level of success with cytotoxic therapies, and the poor 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 7 - 
 
prognosis of patients with advanced cervical cancer, there is certainly an unmet medical 
need for novel, more efficacious, less toxic therapeutic approaches for ICC. 
Doublets containing cisplatin (GOG-0169 and GOG-0179) demonstrated superiority over 
single-agent platinum.10,11 The GOG completed GOG-0204, a phase III, four-arm study 
comparing three cisplatin containing doublets (gemcitabine, vinorelbine, or topotecan) to 
a control arm of cisplatin/paclitaxel.8  No therapy was superior to cisplatin and paclitaxel, 
and the results demonstrated a trend towards improved quality of life, progression-free 
survival, and overall survival in the cisplatin/paclitaxel arm. Thus, paclitaxel/cisplatin 
remained the preferred platinum-based chemotherapy backbone for metastatic or 
recurrent cervical cancer.  On August 14, 2014, the FDA approved the use of 
bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan in 
persistent, recurrent, or metastatic cervical cancer.  This approval was based on the 
results of the GOG-0240 study,12 which noted a statistically significant improvement in 
OS for the bevacizumab plus chemotherapy arm (med OS of 16.8 months for 
bevacizumab plus chemotherapy vs. 12.9 months for chemo alone P=0.0132).  
 
Despite this, there continues to be a large unmet medical need for agents with different 
mechanisms of action (such as antiangiogenics, checkpoint inhibitors, or therapeutic HPV 
immunotherapies) that when used alone or in combination can improve the survival of 
patients with recurrent cervical cancer.8 
  
2.2 
HPV Vaccines 
Squamous cell carcinoma of the cervix requires the constitutive expression of the HPV 
oncoproteins E6 and E7.  Thus, the E6 and E7 antigens have been an intense focus of 
cancer immunotherapies using a variety of vaccine vectors. Because of the intra-cellular 
localization of these antigens, these therapies are mostly directed at cellular immune 
responses.  The ability to deliver antigen to the cytosolic compartment of APCs in order 
to develop HLA class I presentation to induce CD8+ cytotoxic T cell responses is widely 
believed to be necessary for developing an effective therapeutic anti-tumor vaccine. 
 
Several approaches have been employed to develop therapeutic HPV vaccines against 
cervical cancer.  Peptide-based vaccines using E7 peptide have been shown to generate 
cytotoxic T lymphocytes (CTLs) that were protective against HPV-16 E7 positive 
tumors.13-14  One Phase I/II clinical trial immunized 19 terminally ill cervical cancer 
patients with HLA-A*0201-restricted HPV 16 E7 peptide and demonstrated safety, but 
no CTL responses were detected.15 Another Phase II clinical trial in end-stage cervical 
cancer patients used E6 or E7 HLA-A*0201-binding peptides pulsed onto cytokine-
stimulated autologous peripheral blood mononuclear cells (PBMCs).  The trial showed 
that 11 of 16 patients evaluated developed cytotoxic responses.16 Despite this early 
success, peptide-based vaccines have the disadvantage of sometimes leading to tolerance 
rather than activation.  Also, peptide-based vaccines require the identification of epitopes 
associated with a particular MHC allele.  Women who do not share a particular allele 
would not be eligible for treatment. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 8 - 
 
Protein-based vaccines deliver the entire protein for APC processing.  Several studies 
have confirmed the ability to generate HLA class I-restricted CTL responses.17,18A few 
protein vaccines have been tested for the treatment of genital warts or dysplasia in 
humans19-22  and have demonstrated safety and modest immune responses. 
 
Vaccination with live-recombinant viruses has the advantage of high-efficiency DNA 
transduction and gene-expression.  Adenovirus and vaccinia are the two most common 
viral vectors in use.  Phase I/II trials of vaccinia virus expressing E6 and E7 (TA-HPV) 
demonstrated the vaccine to be safe, but only 1 of 8 patients demonstrated an immune 
response.23  A multi-center trial in Europe utilizing this vaccine is currently awaiting 
long-term clinical outcome data.  Recombinant adenovirus encoding multiple tumor-
associated CTL epitopes demonstrated a protective anti-tumor effect against an HPV 16-
transformed cell line.24 One main disadvantage of using these viral vectors is that 
effectiveness may depend on host immunity.  In the case of vaccinia, pre-existing 
immunity secondary to prior vaccination against smallpox may attenuate a vaccine’s 
efficiency.  In the case of adenovirus, the host may mount a significant humoral and 
cellular response to the adenoviral vector, thereby precluding the effectiveness of 
multiple immunizations.  In addition, adverse events that occur often cannot be 
controlled.  For instance, in the 1960's, smallpox vaccination was the cause of a 
substantial number of adverse events and resulted in a lethal infection in approximately 
one out of one million people who received this live vaccinia vaccine.25 Recently the use 
of adenovirus for gene therapy has also resulted in a fatality.26 Dendritic cell (DC) based 
vaccines and modified tumor cell-based vaccines have also been investigated with limited 
success in preclinical models. 
 
The literature provides many references to support the idea that many HPV species 
respond to therapeutic agents based upon HPV-16 E7.27 A phase II study, conducted by 
the New York Phase II Consortium (an NCI-sponsored consortium), immunized 31 
healthy women with biopsy-proven Cervical Intraepithelial Neoplasia (CIN) III with 
three, monthly subcutaneous vaccinations with 500 mcg of SGN-00101 [Heat Shock 
Fusion Protein-Based Immunotherapy (HspE7)].  Of the 31 evaluable patients, 32% 
(10/31) had a complete pathologic response; 39% (12/31) had a partial response and 29% 
(9/31) had stable disease. The overall response rate was 71% (22/31, 95% C.I.=55-87%). 
No patient progressed.  Fifty-five percent (17/31) were HPV-16 positive prior to 
vaccination and one patient had HPV-16 subsequently detected. These results suggest all 
cervical cancer patients (not just those who are HPV-16 positive) would benefit from the 
vaccine targeted at HPV-16 E7. Further, it supports the idea that HPV epitopes are 
sufficient similar to allow efficacy in other HPV types. Research completed by Nventa, 
formerly Stressgen, reports extremely high efficacy using the HPV-16 E7 antigen even in 
non-HPV-16 positive patients; which demonstrates the antigen has immuno-therapeutic 
activity across HPV types.28  Davidson et al. reported cross reactivity to the E7 antigen 
and responses in patients with other HPV types in a trial of a vaccinia based HPV-16 E7 
vector tested in the clinical treatment of high grade vulval intraepithelial neoplasia 
(VIN).29  Luxton et al, reported that 22% of responding women treated with HPV-16 E7 
peptide epitopes for the treatment of cervical dysplasia or neoplasia were negative for 
HPV-16 DNA.30  Slevy et al. reported that B cell epitopes of HPV-16 E7 are cross 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 9 - 
 
reactive with HPV-18.31  Krchnak et al, found while investigating HPV-16 E7 epitopes 
that of the 9 overlapping peptides that were made to map the immunogenic domains, 
some epitopes were type-specific and others were cross reactive with other HPV types.32  
Additional support for the cross reactivity of HPV-16 E7 with other HPV types has been 
demonstrated in human HLA-A2 transgenic mice.33  It further appears that certain HPV-
16 E7 epitopes are conserved across genera, as Nilges et al demonstrated that “…cross-
reactivity represents the inherent nature of the T-cell repertoire” with cross reactivity 
between HPV-16 E7 and Coronovirus protein OC43 NS2.34  
 
2.3 
Recombinant Listeria monocytogenes (Lm) as a Vaccine Vector 
 
The advantages that Listeria monocytogenes possesses as a vaccine vector are rooted in 
its biology.  It is a beta hemolytic gram-positive facultative intracellular bacterium that 
has been used to study cell mediated immunity for decades.35  Listeria preferentially 
infects APC, and unlike other intracellular bacteria like Salmonella, Listeria escape into 
the cytoplasm of the host cell by disrupting the phagosomal membrane.  Also unlike 
Salmonella, Listeria is a gram positive organism, thus does not release endotoxin, a rate 
limiting attribute of Salmonella.  Because Listeria quickly leaves the circulation 
becoming an intracellular infection, and because it replicates in the cytoplasm, humoral 
immunity does not play a major role in combating Listerial infections.  Peptides derived 
from L. monocytogenes in the phagolysosome and the cytosol can be presented by the 
MHC Class I and Class II molecules, inducing both CD4+ and CD8+ T-cell responses.  
Listeria has other useful properties, such as stimulating monopoiesis, stimulating the 
differentiation and maturation of APC, and the generation of a particularly strong innate 
immune response.36   
 
Advaxis builds upon this unique attribute of Listeria by engineering the release of E7 
antigen as a fusion protein to a non-hemolytic fragment of the Listeria protein 
Listeriolysin O (LLO), resulting in more potent and broad CTL responses to the target 
antigen. The HPV tumor antigen proteins E6 and E7 are constitutively expressed in the 
nucleus of HPV associated tumors.  Most therapies targeting these antigens are directed 
at cellular immune responses.  The ability to deliver antigen to the cytosolic compartment 
of APCs in order to develop HLA Class I presentation to induce CD8+ cytotoxic T cell 
responses appears to be an important aspect of developing an effective therapeutic anti-
tumor vaccine. 
 
LLO is a virulence factor of Lm as it enables the bacterium to escape from the 
phagolysosome and thus become virulent.  As such, it appears to have evolved as a target 
of the immune system and stimulates many potentially therapeutic immune responses by 
itself, independent of the microbe.  By using it as part of a fusion protein along with an 
antigen this vaccine secretes a combined antigen-adjuvant directly within both the 
phagolysosome and cytoplasm of APC. 
 
There is evidence that Lm also gets into tumors, probably carried by infected 
macrophages and neutrophils.  One potential consequence of this is the observed ability 
of live Listeria vaccines that secrete an LLO-antigen fusion, but not those that secrete 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 10 - 
 
only an antigen, to diminish regulatory T cells within the tumor, but not in the spleen or 
peripheral tissues.37, 38 
 
2.4  
Listeria monocytogenes Expressing HPV 16-E7 (ADXS11-001 Immunotherapy) 
(06/27/2016) 
 
ADXS11-001 is a live attenuated Listeria monocytogenes (Lm) immunotherapy, 
developed for the treatment of HPV-associated cancers.  ADXS11-001 is bioengineered 
to secrete an antigen-adjuvant fusion protein (tLLO-HPV-E7) consisting of a truncated 
fragment of the listeriolysin O (truncated LLO, tLLO) fused to the full length E7 peptide 
of HPV-16. 
 
ADXS11-001 is manufactured for Advaxis, Inc. by Cobra Biomanufacturing PLC in the 
UK at EU and FDA certified facilities, and with open Drug Master Files in place on both 
continents.  Clinical materials have been manufactured under GMP conditions and in 
compliance with GMP regulations, and are so documented.39-51 
 
2.5 
ADXS11-001 Mechanism of Action (06/27/2016) 
 
ADXS11-001 is rapidly taken up by antigen presenting cells (APC) within the subject.  
This causes activation of the APC and results in a multi-factorial stimulation of innate 
immunity.  To the subject, this activation can manifest as flu-like symptoms or symptoms 
associated with cytokine release that occur during or in the hours immediately following 
administration.  Once inside the APC, ADXS11-001 can escape the phagolysosome into 
the cytoplasm where it secretes the HPV-E7-tLLO fusion protein.  This peptide, along 
with other Lm peptides, is very rapidly ubiquitinated and transported to the proteasome 
where the peptides are broken down and cross-presented through major 
histocompatibility complex (MHC) Class 1 and Class 2 pathways.  This cross-
presentation, in immunologic context of responding to a “perceived” acute infection, 
stimulates the development of adaptive immunity culminating in HPV-specific effector 
T-cells that can infiltrate into the tumor microenvironment (TME) and destroy tumor 
cells immunologically. 
 
Advaxis Lm-LLO immunotherapies have broad effects on the immune system and the 
ability to neutralize mechanisms of immune tolerance.  These Lm-LLO immunotherapies 
take advantage of the ability of Lm to present target antigens in the cytoplasm of APCs 
that generate a target-specific T-cell immunity.  High avidity T-cells are generated where 
possible, but when they are not, Lm stimulates an up-regulation of T-cell responses to 
sub-dominant epitopes.  Advaxis Lm-LLO immunotherapies secrete tumor peptides fused 
to LLO from multiple copies of plasmids.  This increased LLO secretion triggers 
endocrine and exocrine signaling of the immune system that results in a relative reduction 
in the number and function of regulatory T-cells and myeloid-derived suppressor cells 
(MDSC) in the TME, which enables tumor cell killing, even when the T-cells are lower 
avidity.  Tumor antigen specific T-cell immunity generated in the context of Lm-LLO 
immunotherapies can be effective even when targeting self-antigens or viral targets that 
are partially cross-reactive.  Studies have shown that ADXS11-001 has anti-tumor 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 11 - 
 
activity against multiple types of high-risk HPV, including cross-reactive activity where 
there are minor differences in HPV E7 T-cell epitopes.   
 
As an investigational drug product, ADXS11-001 has no direct effect on the tumor tissue, 
but is designed to stimulate the subject’s own immune system to generate an effective 
immune response targeting the tumor-associated antigen like HPV-E7. 
 
2.6 
Summary of Previous Clinical Studies (06/27/2016) 
 
Refer to the Investigator Brochure (IB) for detailed preclinical and clinical data. 
 
2.6.1 Lm-LLO-E7-07:  Phase 1 Experience 
In the initial Phase 1 dose escalation study (Lm-LLO-E7-01), ADXS11-001 was assessed 
in 15 subjects with previously treated metastatic, refractory or recurrent invasive cervical 
cancer.52  ADXS11-001 was administered as an intravenous (IV) infusion at doses of 
1 x 109 to 1 x 1010 CFU followed by a second dose 3 weeks later.  Overall, ADXS11-001 
infusion was safely administered and well tolerated in end-stage subjects who had failed 
multiple prior therapies. 
 
No pre-medications were given in this study and all subjects experienced flu-like 
symptoms and/or symptoms associated with CRS.  The most commonly reported AEs 
were pyrexia (100%), vomiting (60%), chills, headache and anemia (53.3% each), nausea 
and tachycardia (46.7% each), and musculoskeletal pain (26.7%).  At all doses, AEs were 
acute and transient in most subjects, and responded to non-prescription symptomatic 
treatment with no observed listeriosis or Lm shedding.  A total of 9 (60%) subjects 
experienced Grade 3 AEs, and in 6 (40%) of those subjects AEs were considered 
treatment-related (pyrexia in 3 subjects, fatigue in 1 subject, and increased gamma-
glutamyltransferase [GGT] levels in 2 subjects).  No Grade 4 AEs were observed.  The 
highest dose of 1 x 1010 CFU led to a dose-limiting toxicity (DLT) of Grade 2 diastolic 
hypotension.  Under typical interpretation of a DLT (as defined per the protocol) in Phase 
1 clinical studies in refractory cancers, this AE would not have met the criteria for DLT.  
Two deaths occurred during the study period and were considered unrelated to ADXS11-
001 administration.  Although not designed to assess efficacy, stable disease (SD) was 
reported in 7 of 13 (54%) evaluable subjects, and 1 subject (8%) had an unconfirmed 
partial tumor response.  Based on the AE profile, all subsequent studies incorporate the 
administration of NSAIDs and antiemetic medications pre- and post-infusion to help 
reduce the incidence and severity of AEs related to cytokine release.  As an additional 
precaution, a course of oral antibiotics is initiated on Day 3 post-dosing of ADXS11-001 
to assist in clearance of the Lm. 
 
2.6.2 Lm-LLO-E7-15:  Phase 2 Study of ADXS11-001 vs ADXS11-001 and Cisplatin in 
Recurrent, Refractory Cervical Cancer 
 
Lm-LLO-E7-15, was a randomized, multicenter, actively controlled Phase 2 study 
evaluating the safety and efficacy of ADXS11-001 alone compared with ADXS11 001 + 
cisplatin in 110 subjects with advanced cervical cancer that recurred after prior cytotoxic 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 12 - 
 
therapy, including chemotherapy and/or radiotherapy.  Eligible subjects were randomized 
1:1 to ADXS11-001 or ADXS11-001 + cisplatin.  Subjects in the ADXS11-001 group 
received 1 cycle (3 doses of 1 x 109 CFU) of ADXS11-001 at 28-day intervals.  Subjects 
in the ADXS11-001 + cisplatin group received a single dose of ADXS11-001, followed 
28 days later by 5 weekly doses of cisplatin (40 mg/m2), followed 28 days later by 1 
cycle of ADXS11-001; as a precautionary measure, a course of oral antibiotics was given 
to ensure clearance of the Lm .  After first dosing, subjects were followed at 3, 6, 9, 12, 
and 18 months; 109 subjects received 264 doses of ADXS11-001. 
 
The primary endpoint of the study was OS.  Of 109 enrolled subjects, 89 (81.7%) 
subjects at 3 months, 70 (64.2%) at 6 months, 49 (45%) at 9 months, 35 (32%) at 12 
months, and 24 (22%) at 18 months were alive, suggesting that ADXS11-001 is an active 
agent in recurrent cervical cancer.  There was no statistically significant difference in the 
median duration of OS between ADXS11-001 and ADXS11-001 + cisplatin (p = 0.9993), 
nor was there any statistically significant effect of disease status, prior therapy, or Eastern 
Cooperative Oncology Group (ECOG) performance status on OS between treatment 
groups. 
 
Of 69 subjects in the efficacy population, 10% of subjects had an objective tumor 
response.  Complete response (CR) was recorded as the best response in 5 subjects (3 
ADXS11-001; 2 ADXS11-001 + cisplatin), partial response (PR) in 6 subjects (3 
ADXS11-001; 3 ADXS11-001 + cisplatin), SD in 31 subjects (16 ADXS11-001; 15 
ADXS11-001 + cisplatin), and progressive disease (PD) in 27 subjects (13 ADXS11-001; 
14 ADXS11-001 + cisplatin).  Tumor response at 3, 6, 9, 12, and 18 months was 
comparable between treatment groups.  The disease control rate was 39% (42/109).  
Results of the safety profile are shown in Table 1. 
 
2.6.3 GOG-0265:  Phase 2 Evaluation of ADXS11-01 in Recurrent, Refractory Cervical 
Cancer 
 
GOG-0265 is an ongoing study being conducted by the GOG, through sponsorship by the 
NCI Cancer Therapy Evaluation Program (CTEP).  It is a 2-stage study designed to 
evaluate ADXS11-001 (3 doses of 1 x 109 administered every 4 weeks) in subjects with 
advanced, metastatic, or recurrent squamous or non-squamous carcinoma of the cervix 
who have had at least 1 prior systemic chemotherapeutic regimen in the metastatic 
setting.  The primary objectives of the study are to evaluate: 
 
The tolerability, safety, nature and degree of toxicity of ADXS11-001 by the numbers of 
subjects with DLTs and AEs as assessed by CTCAE v 4.03 
To assess the activity of ADXS11-001 for subjects with persistent or recurrent carcinoma 
of the cervix by the frequency of subjects who survive for at least 12 months after 
initiating therapy 
 
Twenty-nine subjects were enrolled to Stage 1 of the study, of which 3 were never treated 
with ADXS11-001.  Among the 26 subjects, 8 (30%) had 1 prior therapy, 14 (54%) had 2 
prior therapies and 4 (16%) had 3 prior therapies for treatment of their metastatic disease.  

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 13 - 
 
The study is being conducted according to the GOG’s standard Simon 2-stage design (for 
recurrent/refractory cervical cancer).  A Stage 1 efficacy bar of 20% 12-month survival 
was established as a predetermined criterion (by a logistic regression model from 17 
studies conducted by GOG in over 500 subjects with recurrent/refractory cervical cancer) 
to be met in order for the study to proceed to Stage 2. Based on the historical data in 
subjects with recurrent/refractory cervical cancer, the expected 12-month survival rate is 
10-15%. 
 
As of May 2015, Stage 1 of GOG-0265 is complete with 26 subjects receiving at least 1 
dose of ADXS11-001.  Stage 2 of the study opened on March 11, 2015 and will enroll 
approximately 37 subjects.  The study has been amended to allow for treatment with 
ADXS11-001 until disease progression as per RECIST 1.1, and to limit the number of 
prior therapies in the metastatic setting to no more than 1 prior therapy. 
 
 
 
2.7 
Summary of Safety of ADXS11-001 (06/27/2016) 
As of January 1, 2015, 573 doses of ADXS11-001 have been administered to 229/230 
enrolled subjects at doses of 5 x 107, 3.3 x 108, 1 x 109, 3.3 x 109, and 1 x 1010 CFU.  In 
the Phase 1 study, 100% of subjects (n=15) have experienced flu-like AEs or symptoms 
associated with cytokine release syndrome. The incorporation of NSAIDs and antiemetic 
medications pre and post infusions has effectively reduced the incidence of these 
symptoms from 100% to 37%.  In addition, a course of antibiotics is given 3 days after 
each dose of ADXS11-001 as a precautionary measure to ensure clearance of the Lm.  
From the clinical experience in 230 subjects, a clear pattern of mild to moderate 
treatment-related AEs consistent with cytokine release symptoms (e.g., constitutional 
symptoms such as fever, chills, rigors, headache, nausea, vomiting, tachycardia, shortness 
of breath, hypotension, and rash) are commonly seen and typically appear 2-4 hours after 
infusion.  Symptoms either self-resolve or respond quickly to symptomatic treatment.   
 
A summary of AEs in >5% of patients by MedDRA system organ class and preferred 
term is presented in Table 1.  There have been no Grade 3-4 drug related AEs observed in 
over 5% of the patient population (see Table 2). 
 
Table 1  Number (%) of Subjects with Adverse Events >5% Incidence (Safety Population, N=230) 
System Organ Class (SOC),Preferred Term, n % [1] 
Grades 1-4 
(N=230) 
Grade 3-4 
(N=230) 
Blood And Lymphatic System Disorders 
 
 
 
Anaemia 
80 (34.8 %) 
35 (15.2 %) 
Cardiac Disorders 
 
 
 
Tachycardia 
13 (5.7 %) 
- 
Gastrointestinal Disorders 
 
 
 
Abdominal Pain 
34 (14.8 %) 
4 (1.7 %) 
 
Constipation 
29 (12.6 %) 
1 (0.4 %) 
 
Diarrhoea 
16 (7.0 %) 
3 (1.3 %) 
 
Nausea 
64 (27.8 %) 
2 (0.9 %) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 14 - 
 
System Organ Class (SOC),Preferred Term, n % [1] 
Grades 1-4 
(N=230) 
Grade 3-4 
(N=230) 
 
Vomiting 
46 (20.0 %) 
4 (1.7 %) 
General Disorders And Administration Site Conditions 
 
 
 
Chills 
89 (38.7 %) 
2 (0.9 %) 
 
Disease Progression 
- 
- 
 
Fatigue 
41 (17.8 %) 
2 (0.9 %) 
 
Oedema Peripheral 
14 (6.1 %) 
- 
 
Pain 
19 (8.3 %) 
3 (1.3 %) 
 
Pyrexia 
71 (30.9 %) 
3 (1.3 %) 
Investigations 
 
 
 
Alanine Aminotransferase Increased 
12 (5.2 %) 
2 (0.9 %) 
 
Aspartate Aminotransferase Increased 
14 (6.1 %) 
2 (0.9 %) 
 
Blood Alkaline Phosphatase Increased 
15 (6.5 %) 
2 (0.9 %) 
 
Blood Creatinine Increased 
16 (7.0 %) 
6 (2.6 %) 
 
Gamma-Glutamyltransferase Increased 
14 (6.1 %) 
3 (1.3 %) 
 
Haemoglobin Decreased 
12 (5.2 %) 
2 (0.9 %) 
 
White Blood Cell Count Decreased 
20 (8.7 %) 
7 (3.0 %) 
Metabolism And Nutrition Disorders 
 
 
 
Decreased Appetite 
21 (9.1 %) 
- 
 
Hypoalbuminaemia 
28 (12.2 %) 
9 (3.9 %) 
 
Hypocalcaemia 
13 (5.7 %) 
2 (0.9 %) 
 
Hypokalaemia 
15 (6.5 %) 
4 (1.7 %) 
 
Hyponatraemia 
19 (8.3 %) 
9 (3.9 %) 
Musculoskeletal And Connective Tissue Disorders 
 
 
 
Back Pain 
17 (7.4 %) 
3 (1.3 %) 
Nervous System Disorders 
 
 
 
Dizziness 
12 (5.2 %) 
- 
 
Headache 
41 (17.8 %) 
- 
Respiratory, Thoracic And Mediastinal Disorders 
 
 
 
Dyspnoea 
14 (6.1 %) 
1 (0.4 %) 
Vascular Disorders 
 
 
 
Hypotension 
16 (7.0 %) 
2 (0.9 %) 
Note:  [1] Percentage is calculated using column header count as denominator for percentage calculation. 
 
Table 2  Number (%) of Subjects with Adverse Events >5% with Respect to Relationship (Possibly Related, 
Probably Related and Related) (Safety Population, N=230) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 15 - 
 
System Organ Class (SOC),Preferred Term, n % [1] 
Grades 1-4 
(N=230) 
Grade 3-4 
(N=230) 
Blood And Lymphatic System Disorders 
 
 
 
Anaemia 
18 (7.8 %) 
2 (0.9 %) 
Gastrointestinal Disorders 
 
 
 
Nausea 
47 (20.4 %) 
- 
 
Vomiting 
31 (13.5 %) 
2 (0.9 %) 
General Disorders And Administration Site Conditions 
 
 
 
Chills 
78 (33.9 %) 
2 (0.9 %) 
 
Fatigue 
27 (11.7 %) 
1 (0.4 %) 
 
Pyrexia 
57 (24.8 %) 
3 (1.3 %) 
Nervous System Disorders 
 
 
 
Headache 
36 (15.7 %) 
- 
Vascular Disorders 
 
 
 
Hypotension 
15 (6.5 %) 
2 (0.9 %) 
Note:  [1] Percentage is calculated using column header count as denominator for percentage calculation. 
 
2.7.1 Delayed/Late Listeria Infection 
 
ADXS11-001 has been attenuated over 4 logs more in comparison to wild-type (wt)-Lm.  
ADXS11-001 is cleared by SCID mice lacking a functioning cellular immune system and 
by gamma interferon knockout mice lacking adaptive immunity.  ADXS11-001 has been 
shown to be nonpathogenic in mouse models. 
 
In a Phase 1 clinical study, in the absence of antibiotics, Lm was rapidly cleared from the 
blood.  No Lm was detected in the blood of any subject beyond 48 hours post-dosing and 
no Lm was detected in the urine and feces in any subject at the highest dose of ADXS11-
001 tested (1 x 1010 CFU).53 
 
Wild type Lm is known to form and persist within biofilms, especially on medical devices 
despite antibiotic treatment.54 Although rare, medical device–related infections such as 
ventriculo-peritoneal shunt infection, peritoneovenous shunt infection, and prosthetic 
joint infection have been reported.55-58 ADXS11-001 is highly sensitive to antibiotics 
such as ampicillin and sulfamethoxazole/trimethoprim, which can be an effective 
treatment regimen for listeria infection.  Therefore, subjects with implanted medical 
device(s) that pose a high risk for colonization and/or cannot be easily removed are 
excluded from this study.  In addition, all subjects will receive a course of oral antibiotics 
beginning on Day 4 (approximately 72 hours) after each dose of ADXS11-001 and for 
6 months following the last dose of ADXS11-001 to aid in the eradication of the bacteria. 
 
As of September 2015, approximately 263 subjects have received approximately 
675 doses of ADXS11-001.  During the course of treatment in this subject population, 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 16 - 
 
there has been one reported case of Grade 3 listeriosis (0.38%).  The subject was a 
56 year old female who was enrolled in November 2012 in Study GOG-0265.  During the 
course of her participation in the study, she suffered a motor vehicle accident, and as a 
result, required multiple orthopedic surgeries involving the placement of hardware and a 
bone graft.  After completing her participation in the study, she went on to receive 
multiple other treatments for her metastatic cervical cancer including an investigational 
PI3K inhibitor.  Two and a half years after completing her last administration of 
ADXS11-001, she presented to the hospital with mental confusion and a fever.  Blood 
cultures were positive for Lm.  Subsequent analyses revealed that the isolate was the 
same as ADXS11-001 but without the plasmid.  The subject was admitted to the hospital 
and treated with IV ampicillin.  She became afebrile and was discharged home 3 days 
after her admission.  Prior to her discharge, a lumbar puncture and a CT of the brain were 
recommended but the patient refused.  Two weeks later, the subject presented with acute 
respiratory distress caused by her metastatic disease and died.  The Investigator ruled the 
cause of death was due to disease progression (metastatic cervical cancer).  It is 
hypothesized that dosing of attenuated Lm soon after her bone graft likely resulted in 
biofilm formation, which protected the organisms from both the immune system and 
antibiotics.  At no time while the subject was on study or during the 2.5 years post-study 
did she show signs or symptoms of listeriosis.  Genomic sequencing confirmed by PCR 
later revealed that the Lm was avirulent, and therefore incapable of spreading cell-to-cell.  
The Lm isolate also remained highly susceptible to multiple antibiotics.  Please see 
Section 6.3- “Listeriosis and Listeria Infection – Identification and Management.” 
(06/27/2016) 
 
2.8 
Rationale for Survival Endpoint and Confirmation of Progression (5/23/2011) 
 
Unlike cytotoxic therapies which directly kill tumor cells and diminish tumor size, 
immunotherapies work through different pathobiologic mechanisms and often work more 
slowly.  First, they effect changes in the immune system and then those changes exert a 
therapeutic effect on the disease.  This process may take months to fully occur.  In 
patients with rapidly progressive disease such as melanoma, immunotherapies have been 
observed to result in strong objective responses even in patients whose disease progressed 
initially after the onset of treatment59-61; which would be defined as a therapeutic failure 
under RECIST criteria and would be a response not observed at all if the evaluation 
model was based upon progression free survival (PFS), as the patient would not have 
been evaluated on-study subsequent to initial disease progression. However these patients 
experienced overall survival matching those who had exhibited traditional PR and CRs. 
Whereas PFS is an adequate surrogate for overall survival when treating with cytotoxic 
agents, multiple studies of immunotherapy have demonstrated that PFS does not correlate 
with overall survival and therefore is an inadequate surrogate for overall survival in 
immunotherapy. (5/23/2011) 
 
The patient population in this current trial has historically been associated with a median 
life expectancy of approximately 6 months, making the collection of survival data 
practical.  Because tumor-measurement based response and PFS based on RECIST are 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 17 - 
 
inadequate surrogates for clinical benefit and survival in immunotherapy, time to death is 
the primary efficacy endpoint in this trial. (5/23/2011) 
 
Because a positive response to an immunotherapy treatment will always involve the 
infiltration of tumor-specific white blood cells and local inflammation in the tumor tissue 
at some point, the total lesion size circumscribed by the “tumor” area will typically have 
an initial increase in size before it begins to shrink. For this reason, particular care must 
be applied when using tumor measurement-based criteria like RECIST to make clinical 
decisions about determining disease progression.  (5/23/2011) 
 
2.9 
Rationale for restricting enrollment to patients who have received only one prior 
chemotherapy regimen (12/23/2013) (06/27/2016) 
 
Immunotherapy of cancer is an indirect form of cancer treatment. In order for patients to 
derive potential clinical benefit, they need to mount an immunologic response after the 
treatment is administered in order for their immune system to resist progression, or 
induce tumor responses against their malignancy.   For ADXS11-001, clinical benefit is 
presumed to be based on the generation of tumor-antigen specific adaptive immunity, 
infiltration of those cells into the tumor and a reduction in regulatory T-cell (Treg) and 
myeloid-derived suppressor cell (MDSC) mediated immunologic tolerance within the 
tumor microenvironment. The best responses in-vitro were seen after three treatments 
because each subsequent treatment has a “booster effect” resulting in greater numbers of 
antigen specific cytotoxic T-cells. It takes time for such an immunologic response to 
develop and ultimately be reflected in the growth characteristics of a patients tumors. For 
this reason most immunotherapies are not typically assessed until after 12 weeks and 
apparent minor asymptomatic progressions are re-evaluated after 3-4 additional weeks to 
confirm progression when there are no alternative treatment options available.  
   
Unfortunately, many late-stage cervical cancer patients that have failed multiple 
chemotherapy regimens do not live for very long and the multiple prior chemotherapies 
can impair their hematologic capacity and reduce their relative immunologic function. In 
the “run-in” phase, several patients expired from disease progression before they were 
able to receive all three ADXS11-001 treatments and/or be assessed. For these reasons, 
amending the protocol to enroll patients who have not received more than one prior 
chemotherapy regimen in the recurrent setting better enables the opportunity for clinical 
benefit and assessment in this refractory patient population. 
 
2.10 
Rationale for Additional Treatment Cycles (03/09/2015) 
 
ADXS11-001 treatment essentially employs two critical pathobiologic effects that work 
together to contribute toward clinical benefit in patients.  One can be described as its 
“vaccine effect” which results in the generation of tumor antigen specific cytotoxic T 
cells which replicate and distribute throughout the body and have been shown to 
concentrate in tumors.  The second is the ability of Lm-LLO vectors to induce a relative 
reduction in the number of immunologic inhibitory cells, Tregs and MDSCs in the tumor 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 18 - 
 
microenvironment coupled with a greatly reduced capacity of Tregs and MDSCs to 
secrete the inhibitory cytokines IL-10 and arginase-1 (respectively). 
 
Each time a patient receives an infusion of ADXS11-001, more T-cells are generated 
which can migrate to the tumors and mediate CD8+ T cell killing of tumor cells.  
Repeated dosing every 3-4 weeks x three has been established in animal models to 
develop a “booster effect” resulting in a greater number of antigen-specific CD8 T cells.  
Larger numbers of antigen specific T-cells in the periphery as well as infiltrating tumors 
consistently results in better tumoricidal effects.  Therefore more T cells equals better 
tumor killing.  Furthermore, in these models, higher doses (CFUs) consistently resulted in 
a greater number of antigen specific CD8+ T cells, which engenders better tumorcidal 
activity, therefore establishing a clear “dose effect”.  Unlike most vaccine approaches, 
Advaxis LM-LLO vectors do not generate neutralizing antibodies which enables the 
potential of giving repeating cycles of treatment to patients who could potentially benefit.  
Together, since repeating doses of ADXS11-001 generates more tumoricidal CD8+ 
Tcells and since there is no contraindication to giving repeating cycles of treatment.  
Patients with bulky and/or resistant tumors may benefit from adding repeated cycles of 
treatment beyond the initial 3-dose cycle.  Each subsequent cycle can generate more 
cancer fighting cells and could deepen or help maintain clinical benefit achieved from the 
initial cycle of treatment.  This is particularly relevant in settings where additional 
treatment options are limited. 
 
The ability of Lm-LLO vectors to reduce the number and function of inhibitory Treg and 
MDSCs within the tumor microenvironment is a relatively recent discovery that is 
exclusively associated with Advaxis Lm-LLO vectors like ADXS11-001.  The precise 
mechanism is still under investigation, but it clearly involves a relative reduction in the % 
of T regs and MDSCs coupled with a massive change in the ratio of effector to 
suppressor cells in the tumor micro-environment (TME).  It is also clearly linked to the 
secretion of the tLLO fusion peptide by the live attenuated vectors.  Furthermore, in 
animal models the suppressor cells remaining in the TME virtually lose their ability to 
secrete inhibitory cytokines for a generation.  The duration of this change in suppressor 
function in patients remains undetermined thus far.  However, clinical evidence would 
suggest that it is temporary because there is no evidence of autoimmunity and also since, 
after one 3-dose treatment cycle, partial tumor responses were observed that remained 
constant for several months and subsequently begin to grow again after 6 or 9 months. 
 
Each administration of the live attenuated vectors results in a new secretion of the tLLO 
fusion peptide which would thereby re-establish the conditions that inhibit suppressor cell 
activity within the tumor microenvironment.  Therefore repeating doses or cycles of 
treatment could benefit the patient by helping to overcome tolerance in the tumor 
microenvironment. 
 
Taking all of these things together, if a patient has resistant or bulky disease, tolerates 
initial treatment well and still has evidence of residual tumor, they may benefit from 
receiving repeating cycles of treatment.  Each administration generates more tumor-

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 19 - 
 
specific CD8+ T cells which can fight against the tumors as well as re-establish a tumor 
microenvironment beneficial to effector T cell activity. 
 
In the case of recurrent cervical cancer, there are limited treatment options.  ADXS11-
001 has been shown to improve survival and generate tumor responses, including 
complete responses, in some patients after only one 3-dose cycle of treatment.  While the 
median duration of response to one cycle was 9.5 months, it remains to be determined 
whether additional cycles of treatment might have further prolonged or even furthered 
these clinical benefits.  Since ADXS11-001 is relatively well tolerated and there is no 
contraindication to repeated dosing, and since each administration can generate more 
effector cells and re-establish a tumor microenvironment favorable to tumorcidal activity 
and since additional treatment options are limited; we propose to allow repeated cycles of 
treatment for patients entered in the second stage of accrual to GOG-0265 who tolerate 
their initial treatments and still have residual evidence of tumors. 
 
2.11 
Inclusion of Women and Minorities (12/23/2013) 
 
The Gynecologic Oncology Group and GOG participating institutions will not exclude 
potential subjects from participating in this or any study solely on the basis of ethnic 
origin or socioeconomic status.  Every attempt will be made to enter all eligible patients 
into this protocol and therefore address the study objectives in a patient population 
representative of the entire cervical cancer population treated by participating institutions. 
 
3.0 
PATIENT ELIGIBILITY AND EXCLUSIONS  
 
3.1 
Eligible Patients  
 
3.1.1 Patients must have persistent or recurrent squamous or non-squamous cell carcinoma, 
adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease 
progression (disease not amenable to curative therapy).  Histologic confirmation of the 
original primary tumor is required via the pathology report. 
 
3.1.2 Patient must have measurable disease as defined by RECIST 1.1. Measurable disease is 
defined as at least one lesion that can be accurately measured in at least one dimension 
(longest dimension to be recorded). Each lesion must be  10 mm when measured by CT, 
MRI, or caliper measurement by clinical exam; or  20 mm when measured by chest x-
ray.  Lymph nodes must be > 15 mm in short axis when measured by CT or MRI. 
 
3.1.3 Patient must have at least one “target lesion” to be used to assess response on this 
protocol as defined by RECIST 1.1 (Section 8.1).  Tumors within a previously irradiated 
field will be designated as “non-target” lesions unless progression is documented or a 
biopsy is obtained to confirm persistence at least 90 days following completion of 
radiation therapy. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 20 - 
 
3.1.4 Patients must not be eligible for a higher priority GOG protocol, if one exists.  In general, 
this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient 
population. 
 
3.1.5 Patients must have a GOG performance Status of 0 or 1. (12/23/2013) 
 
3.1.6 Recovery from effects of recent surgery, radiotherapy, or chemotherapy (06/27/2016) 
 
3.1.6.1 Any hormonal therapy directed at the malignant tumor must be discontinued at least one 
week prior to registration.  Continuation of hormone replacement therapy is permitted. 
 
3.1.6.2 Any other prior therapy directed at the malignant tumor, including chemotherapy, 
biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued 
at least three weeks prior to registration. (02/06/2012) 
 
3.1.6.3 Any prior radiation therapy must be completed at least 4 weeks prior to registration. 
(02/06/2012) 
 
3.1.7 Prior therapy (12/23/2013) 
 
3.1.7.1 Patients must have had one prior systemic chemotherapeutic regimen for management of 
advanced, metastatic, or recurrent carcinoma of the cervix.   
 
Chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is 
not counted as a systemic chemotherapy regimen for management of advanced, 
metastatic, or recurrent disease.  Adjuvant chemotherapy given following the completion 
of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as 
a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent 
disease (e.g.; paclitaxel and carboplatin for up to 4 cycles). (02/06/2012) 
 
3.1.7.2 Patients are allowed to receive, but are not required to receive, biologic/targeted (non-
cytotoxic) therapy as part of their primary therapy and/or as part of their therapy for 
advanced, metastatic, or recurrent disease (e.g., bevacizumab). (02/06/2012) 
 
3.1.8 Patients must have adequate: (06/27/2016) 
 
3.1.8.1 Bone marrow function: Platelet count greater than or equal to 75,000/mcl and ANC count 
greater than or equal to 1,000/mcl. Lymphocyte count greater than or equal to 700/mcl. 
Hemoglobin count greater than or equal to 9 g/dL or greater than or equal to 5.6 mmol/L.  
(Note:  ANC, Platelets, Hemoglobin requirement cannot be met by the use of recent 
transfusions, or growth factor support (G-CSF, erythropoietin, etc.) within 2 weeks prior 
to treatment initiation.) 
 
3.1.8.2 Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal 
(ULN) or measured or calculated creatinine clearance greater than or equal to 50 mL/min 
for subject with creatinine levels greater than 1.5 x institutional ULN.  (GFR can also be 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 21 - 
 
used in place of creatinine or CrCl) (Creatinine clearance should be calculated per 
institutional standard.)  
 
3.1.8.3 Hepatic function: Total bilirubin less than or equal to 1.5 x ULN.  AST, ALT, less than or 
equal to 3 x ULN, and alkaline phosphatase less than or equal to 2.5 x ULN. 
(02/06/2012) 
 
3.1.8.4 Coagulation function:  INR or PT and aPTT less than or equal to 1.5 x ULN, unless 
patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic 
range of intended use of anticoagulants.   
 
3.1.8.5 Neurologic function:  Neuropathy (sensory and motor) less than or equal to Grade 1. 
 
3.1.9 Patients must have signed an approved informed consent and authorization permitting 
release of personal health information. 
 
3.1.10 Patients must meet pre-entry requirements as specified in Section 7.0. 
 
3.1.11 Patients of childbearing potential must have a negative serum pregnancy test prior to the 
study entry and must agree to ongoing use of 2 methods of study doctor approved birth 
control or abstain from heterosexual activity for the course of the study from Screening 
through 120 days after the last dose of study medication.  Patients of childbearing 
potential are those who have not been surgically sterilized or have not been free from 
menses for >1 year.   (5/23/2011) (06/27/2016) 
 
3.1.12 Patients cannot be lactating.  
 
3.1.13 Patients must be > 18 years old. 
 
3.1.14 Patients must be able to swallow pills. 
 
3.2 
Ineligible Patients  
 
3.2.1 Patients who have received prior therapy with ADXS11-001. 
 
3.2.2 Patients who are currently receiving or who have received an investigation therapy within 
30 days prior to registration.  (06/27/2016) 
 
3.2.3   Patients who are currently receiving or who have received any PI3K inhibitor within 30 
days prior to registration. (06/27/2016) 
 
3.2.4 Patients with a history of other invasive malignancies, with the exception of non-
melanoma skin cancer and other specific malignancies as noted in Sections 3.23 and 3.24, 
are excluded if there is any evidence of other malignancy being present within the last 
three years.  Patients are also excluded if their previous cancer treatment contraindicates 
this protocol therapy. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 22 - 
 
 
3.2.5 Patients who have received prior radiotherapy to any portion of the abdominal cavity or 
pelvis OTHER THAN for the treatment of cervical cancer within the last three years are 
excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is 
permitted, provided that it was completed more than three years prior to registration, and 
the patient remains free of recurrent or metastatic disease.  
 
3.2.6 Patients who have received prior chemotherapy for any abdominal or pelvic tumor 
OTHER THAN for the treatment of cervical cancer within the last three years are 
excluded. Patients may have received prior adjuvant chemotherapy for localized breast 
cancer, provided that it was completed more than three years prior to registration, and 
that the patient remains free of recurrent or metastatic disease.  
 
3.2.7 Patients with a contraindication (e.g. sensitivity/allergy) to 
trimethoprim/sulfamethoxazole or ampicillin. (5/23/2011) (10/22/2012) (06/27/2016) 
 
3.2.8 Patients allergic to NSAIDs. (06/27/2016) 
 
3.2.9 Patients with active infection requiring systemic therapy or who are dependent on or 
currently receiving antibiotics that cannot be discontinued before dosing.  (Note:  
Subjects who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after 
the last dose of antibiotic before receiving any ADXS11-001 infusion). (06/27/2016) 
 
3.2.10  Patients with a diagnosis of immunodeficiency, or who are dependent on or have received 
systemic steroid therapy or any other form of immunosuppressive therapy within 7 days 
prior to the first dose of trial treatment with the exception of topical corticosteroids and 
occasional inhaled corticosteroids, as indicated. (5/23/2011) (10/22/2012) (06/27/2016) 
 
3.2.11 Patients with uncontrolled intercurrent illness including, but not limited to ongoing or 
active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac 
arrhythmia, or psychiatric illness/social situations that would limit compliance with study 
requirements. 
3.2.12  Patients with liver cirrhosis or any other impaired hepatic function as determined by 
serum enzymes (see Section 3.183). (06/27/2016) 
3.2.13  Patients known to be seropositive for HIV and/or active hepatitis, even if liver function 
studies are in the eligible range. 
3.2.14 Patients with a prior history of a splenectomy and/or sickle cell trait/disease. 
3.2.15 Patient has implanted medical device(s) that pose a high risk for colonization and/or 
cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, 
orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)).  
NOTE:  More common devices and prosthetics which include arterial and venous stents, 
dental and breast implants and venous access devices (e.g., Port-a-Cath or Mediport) are 
permitted.  Sponsor must be contacted prior to consenting any subject who has any other 
device and/or implant. (06/27/2016) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 23 - 
 
3.2.16 Any patient currently requiring or anticipated to require tumor necrosis factor (TNF) 
blocking agent (e.g., infliximab) therapy for diagnosis of rheumatologic disease or 
inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn disease, plaque 
psoriasis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis). (06/27/2016) 
 
3.2.17 Patient has undergone a major surgery, including surgery for a new artificial implant 
and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment.  NOTE: 
All toxicities and/or complications must have recovered to baseline or Grade 1 prior to 
the initiation of ADXS11-001 study therapy.  Sponsor must be consulted prior to 
enrolling patients on the study who recently had a major surgery or have new artificial 
implant, and/or devices. (06/27/2016) 
 
3.2.18 Patient has a known allergy to any component of the study treatment formulations. 
(06/27/2016) 
 
3.2.19 Patient has a history of listeriosis or prior ADXS11-001 therapy. (06/27/2016) 
 
4.0 
STUDY MODALITIES   
 
4.1 
ADXS11-001 (IND #13,712) 
 
4.1.1 IND Sponsor:  Advaxis Inc. (03/09/2015) 
To obtain a copy of the IND effective letter or for questions pertaining to the IND, 
institutions should contact (5/23/2011): 
 
Robert Ashworth 
Advaxis Inc. 
Phone: 609-250-7508 
e-mail: ashworth@advaxis.com (06/27/2016) 
 
 
4.1.2 Description: (03/09/2015) (06/27/2016) 
 
ADXS11-001 is a free flowing isotonic, aqueous, cream colored suspension at a pH of 
6.8-7.8 supplied in a DIN 2R glass vial (4mL), stoppered with a grey rubber stopper and 
sealed with an aluminum seal and a blue flip off cap that must be stored frozen at -80 ± 
10°C. 
 
4.1.3 How Supplied, Storage and Stability: (12/23/2013) (03/09/2015) (06/27/2016) 
 
ADXS11-001 is provided on dry ice via bonded courier delivery with temperature 
monitors in 1.2 mL vials of which 1.0 ml is to be used in the preparation of a dose.  
ADXS11-001 must be received frozen on dry ice and immediately stored at -80 ± 10°C.  
ADXS11-001 is stable for 6 hours when stored at room temperature (temperatures at or 
below 25°C [77°F]). This 6 hour time allows for vial thaw, preparation of infusion and 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 24 - 
 
administration.  The 60 minute ADXS11-001 infusion at room temperature must be 
completed within 6 hours of product vial removal from freezer.   
 
4.1.4 Storage and Stability: (12/23/2013) (03/09/2015) (06/27/2016) 
 
ADXS11-001 must be received frozen on dry ice and immediately stored at -80 ± 10°C.   
Even though ADXS11-001 is non-pathogenic, all L. monocytogenes species are classified 
as Biosafety Level 2 (BSL-2) according to the Biosafety in Microbiological and 
Biomedical Laboratories (BMBL) 5th Edition.  Universal precautions and institutional 
guidelines should be used when handling investigational drugs and human specimens. 
 
Aseptic technique must be strictly observed throughout the preparation procedure 
including the use of a biologic safety cabinet or hood since ADXS11-001 is live, 
attenuated L. monocytogenes. 
 
Prior to preparation, the frozen vial of ADXS11-001 should be thawed at room 
temperature at or below 25°C (77°F) for approximately 5 to 10 minutes. 
 
Parenteral drug products should be inspected visually for particulate matter and 
discoloration prior to administration. Discard the drug product vial if extraneous 
particulate matter other than slightly turbid white to off white suspension is observed. 
 
Do not use ADXS11-001 if discoloration is observed. 
 
Each dose of ADXS11-001 must be prepared in sterile 0.9% Sodium Chloride Injection, 
USP (normal saline) and patient must be dosed within 6 hours of drug product removal 
from the freezer. 
 
ADXS11-001 MUST NOT BE MIXED WITH OTHER DILUENTS. 
 
Once the vial is removed from the freezer, the ADXS11-001 product is stable at room 
temperature (temperatures at or below 25°C [77°F]) for 6 hours.  The 6 hours includes 
the drug product vial thaw, dose preparation, room temperature storage of the prepared 
dose in the IV bag AND the duration of infusion. 
 
DO NOT ADMINISTER THE PRODUCT AS AN (INTRAVENOUS [IV] PUSH OR 
BOLUS). 
 
DO NOT COMBINE, DILUTE OR ADMINISTER IT AS AN INFUSION WITH 
OTHER MEDICINAL PRODUCTS.  
 
ADXS11-001 and all other IV study medications must be administered through a 
temporary IV, which will be removed prior to discharge. 
If a patient has an existing portacath or infusion port, it must not be used for any 
purpose on the day of infusion (Day 1) through approximately 72 hours following 
the administration of ADXS11-001 and after the initiation of oral antibiotics (Day 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 25 - 
 
4).  For example, if a patient had an infusion on a Monday, the portacath or infusion port 
cannot be used again until Thursday, after the patient has taken the first dose of 
antibiotics. 
In order to prevent accidental use of the portacath or infusion port, additional safety 
measures must be implemented at the study site.  Reminder stickers that state, “DO NOT 
USE PORTACATH/INFUSION PORT” must be attached to the following items: 
 
Portacath/infusion port site 
 
All study medication IV bags 
 
In front of patients chart (when applicable) 
(06/27/2016)  
 
4.1.5 Handling Precautions: (05/06/2013) (03/09/2015) (06/27/2016)   
 
ADXS11-001 is classified a BSL-2, minimally pathogenic.  Precautions as stated in the 
BMBL 5th Edition61 [62] include:  
 
Agent: ADXS11-001, live attenuated genetically engineered live vaccine (5/23/2011) 
ADXS11-001 is a live attenuated strain of Listeria monocytogenes (Lm) that has been 
attenuated such that it is cleared by severe combined immunodeficiency (SCID) mice 
lacking cellular immunity and gamma interferon knock-out mice lacking adaptive 
immunity.  It has also been altered such that it is impossible for it to recombine with 
wild-type Lm.  In the Phase 1 study no bacterial shedding was detected from any subjects 
treated with ADXS11-001.  It is considered as a non-infectious BSL-1 agent for transport 
by the CDC. 
 
Wild type Listeria is Gram-positive, non-spore-forming, facultative bacilli that are 
hemolytic and catalase-positive.  It is a naturally occurring bacterium that is present in 
the environment and is known to cause illness in some people when they eat foods 
contaminated with Lm.  Although healthy adults and children can contract a wild-type 
Listeria infection, they do not usually become seriously ill.  People at risk of severe 
illness from wild-type Listeria are pregnant women, newborns, and persons with 
impaired immune function.   
 
Even though ADXS11-001 is non-pathogenic, all Lm species are classified as BSL-2 
according to the BMBL 5th Edition.  Universal precautions and institutional guidelines 
should be used when handling investigational drugs and human specimens.  Except for 
the transmission of mother to fetus, human-to-human transmission of Lm is not known to 
occur.63  Shedding studies completed in Phase 1 demonstrated that, in the absence of 
antibiotics, ADXS11-001 was rapidly cleared from the blood with no Lm detected in the 
blood of any subject beyond 48 hours post-dosing, and no Lm was detected in the urine 
and feces in any subject at the highest dose of ADXS11-001 tested (1 x 1010 CFU).64 .   
 
Based on the mechanism of action of ADXS11-001 and the inability of Lm to be 
transferred from human-to-human, there is no need for subjects who receive ADXS11-
001 to avoid contact with people who are elderly, pregnant, newborns, or have weakened 
immune systems. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 26 - 
 
 
Precautions as stated in the BMBL 5th Edition include: 
 
Wild-type L. monocytogenes poses a potential hazard to laboratory personnel.  The 
Gram-positive, non-spore-forming, aerobic bacilli are hemolytic and catalase-positive. 
Bacteria have been isolated from soil, dust, human food, animals, and asymptomatic 
humans. Most cases of listeriosis have arisen from eating contaminated food products, 
most notably soft cheeses, raw meat, and unwashed raw vegetables.  Although healthy 
adults and children can contract a Listeria infection, they do not usually become 
seriously ill. At risk of severe illness are pregnant women, newborns, and persons with 
impaired immune function. 
 
Laboratory Hazards: Wild-type Listeria monocytogenes are ubiquitous in the 
environment and may be found in feces, cerebrospinal fluid (CSF), and blood, as well as 
food and environmental materials. Ingestion is the most common mode of exposure, but 
wild-type Listeria can also cause eye and skin infections following a direct exposure. 
Wild-type Lm infections in pregnant women occur most often in the third trimester and 
may precipitate labor. Transplacental transmission of Lm poses a grave risk to the fetus 
and may result in disseminated abscesses contributing to a mortality rate of nearly 100%. 
 
Recommended Precautions: BSL-2 practices, containment equipment, and facilities are 
recommended for activities with clinical specimens and cultures known or suspected to 
contain the agent. Gloves and eye protection should be worn while handling the agent.  
Pregnant women who work with Lm in the clinical or research laboratory setting should 
be fully informed of the potential hazards associated with the organism, including 
potential risks to the fetus. 
 
Disposing of Contaminated Materials: 
 
Gloves should be used while cleaning spills.  Unless ingested orally or parenterally no 
pathologic hazard exists.  Contaminated materials can be disposed of in sealed containers 
as medical waste (e.g. closed plastic bags).  Spills should be washed and cleaned with the 
application of commercial chlorine bleach (e.g. Clorox).  See Section 4.1.12.  
 
4.1.6 Drug preparation and administration: (03/09/2015) (06/27/2016) 
Only sterile containers will be used in the preparation of these materials.  They may be 
autoclaved glassware, disposable containers, or other sterile materials as provided for 
within each institution’s SOP. 
 
Please note that ADXS11-001, the Investigational Study Drug, is a live, highly attenuated 
microbe, L monocytogenes, which can multiply, thus increasing the dosage, or die off, thus 
decreasing the dosage.  ADXS11-001 is stable for 6 hours when stored at room temperature 
(temperatures at or below 25°C [77°F]). This 6 hour time allows for vial thaw, preparation of 
infusion and administration.  The 60 minute ADXS11-001 infusion at room temperature must 
be completed within 6 hours from product vial removal from the freezer.   
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 27 - 
 
A dose of study drug is prepared in the following manner: 
 
Remove the appropriate number of vials from -80 ± 10°C and thaw the vials at room 
temperature for approximately 5 to 10 minutes.  Gently agitate mildly by hand to ensure 
that the study drug is in suspension.  Prepare the dose and infusion volume of ADXS11-
001 as described below. 
 
To make a dose of 1 x 109 cfu:  Thaw 1 vial of the ADXS11-001 study drug at room 
temperature (temperatures at or below 25°C [77°F]). Gently agitate the vial mildly by 
hand to ensure that the study drug is in suspension. Withdraw 0.53 mL of ADXS11-001 
suspension and add it to the infusion bag for a final volume of 250 mL and mix 
thoroughly.  
 
Each prepared dose of ADXS11-001 must be administered at room temperature 
(temperatures at or below 25°C [77°F]) within 6 hours from product vial removal 
from the freezer.  This includes vial thaw, room temperature storage of the vial, 
dose preparation, storage of the infusion suspension in the IV bag and the duration 
of the infusion.  Administer ADXS11-001 at room temperature intravenously over a 
60-minute infusion time. 
 
The time the vial is removed from the freezer is to be recorded (T0). (5/23/2011) 
 
Doses will be administered to patients who have received the prophylactic medication 
specified in the protocol as a 60 minute intravenous (IV) infusion. The actual time of 
administration is to be recorded (T1). The actual time the infusion is completed is to be 
recorded (T2).   
PLEASE SEE Section 4.1.4 for important information regarding the use of a 
temporary IV line and the placement of reminder stickers.  
 
4.1.7 Adverse Effects: (03/09/2015) (06/27/2016) 
 
4.1.7.1 Please refer to Section 2.6 for summary information on the ADXS11-001 AE profile. 
 
4.1.7.2 ADXS11-001 is a live attenuated bioengineered nonpathogenic strain of Lm, and one that 
is known to stimulate a strong innate immune response characterized by high levels of 
cytokine release from immune cells into the general circulation.  This pattern of side 
effects is consistent with other immunotherapy agents. 
 
4.1.7.3 The most likely AEs associated with ADXS11-001 are comprised primarily of individual 
flu-like symptoms (e.g., fever, chills, body ache, and fatigue) or cytokine release 
symptoms (e.g., headache, nausea, vomiting, tachycardia, shortness of breath, 
hypotension and rash).  The symptoms usually present within 2-4 hours after the 
completion of infusions and are often mild to moderate and transient in nature or respond 
quickly to symptomatic treatment.  In rare instances they may last up to 24 hours.  No 
cumulative toxicity has been observed.   
  

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 28 - 
 
Less likely AE’s include increase heart rate, low blood pressure, muscle aches, 
headaches, allergic reaction, changes in blood chemistry, changes in blood counts, and 
short term changes in liver function. 
 
Rare but serious AEs include high fever, difficulty breathing and hypotension. 
(5/23/2011) (12/23/2013) 
 
4.1.7.4 Like all Listeria, ADXS11-001 has a tropism for the liver.  Transient asymptomatic 
elevations of ALT and alkaline phosphatase were observed after dosing in phase 1 trials 
without prophylactic medication administration.  For that reason, patients with significant 
liver disease are excluded, and particular attention is to be paid to hepatic abnormalities. 
(5/23/2011) 
 
Please reference the ADXS11-001 Investigator Brochure for complete information 
regarding adverse effects. 
 
4.1.8 Drug Ordering and Distribution: (12/23/2013) (03/09/2015) (06/27/2016) 
 
ADXS11-001 will be supplied by Advaxis and distributed by Almac Clinical Services 
LLC.  No supplies will be shipped to any site until regulatory approval has been obtained.  
There will NOT be an initial drug supply forwarded to all investigational sites upon 
initial regulatory approval. 
 
The designated person(s) from each participating institution must complete a GOG-0265 
“Pharmacy Information Form” and submit to the GOG Administrative Office along with 
the required regulatory documents (see Section 5.0) and GOG will forward to Advaxis. 
 
4.1.8.1 Initial and Subsequent Drug Requests: (12/23/2013) (03/09/2015) 
When a patient is registered, the study site is to complete a “Drug Order Request Form” 
and e-mail the completed form to Almac and Advaxis.   
 
ATTN: palogistics.clinicalservices@almacgroup.com  
 
CC: 
larry.haines@almacgroup.com  
 
logistics@advaxis.com  
 
Study drug is not patient specific.  You may order multiple vials of study drug to 
accommodate more than one patient depending upon the enrollment expectations at your 
site and storage capacity at   -80 ± 10°C.  (4 vials are required per patient to cover the 
first three months of treatment protocol).  
 
ADXS11-001 will be shipped from Almac Clinical Services directly to the institution. 
Shipments will be made Monday through Thursday for Tuesday through Friday delivery 
per the table below.  To ensure ample time for delivery, drug requests must be received 
by Almac before 12:00 pm Eastern Standard Time (EST) Monday through Wednesday.  

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 29 - 
 
If the drug request is received prior to 12 noon, that will be considered Day 1.  Study 
drug will be shipped Day 2 to arrive on site Day 3 before 10:30 am local time.  
 
Orders in (by 12 
PM EST) 
Shipment Out 
Expected Delivery 
Monday 
Tuesday 
Wednesday 
Tuesday 
Wednesday 
Thursday  
Wednesday 
Thursday  
Friday 
Thursday  
Monday 
Tuesday 
Friday 
Monday 
Tuesday 
EST = Eastern Standard Time 
 
4.1.9 Cold Chain Verification (12/23/2013) (03/09/2015) (06/27/2016) 
Cold chain verification must be completed immediately before unpacking the shipment, 
by carefully following the instructions below:   
 
TempTale USB4 Temperature Recorder Review Instructions 
 
Please note that study drug is shipped at -70oC and has a TempTale USB4 (temperature 
monitor) included in the box.   It is imperative that all study drug shipments be stored 
at -80 ± 10°C immediately after being removed from the shipping container. 
 
Cold Chain Verification must be completed immediately before unpacking the shipper, by 
carefully following the instructions below: 
TempTale USB4 Temperature Recorder 
 
 
Stopping the Monitor: 
On receipt of the shipment, the TempTale USB4 temperature recorder should be stopped.  
For this the RED stop button is held down firmly for 3 seconds.  A hexagonal “STOP” 
icon appears in the upper right hand corner of the display. 
 
Alarm: 
Display 
Stop Button 
USB Adapter & 
Cable 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 30 - 
 
A small blinking “BELL” icon 
 is on the display after the device has been stopped.  
This means that during the transport a significant temperature excursion occurred.  Please 
follow steps 1-6.   
 
Plug the USB cable into your computer. 
Copy both files from the USB device into an e-mail. 
Specify the subject header with Protocol Name, Site Name/No. and Shipment No. 
Please send an e-mail with both attachments to Almac and Advaxis via the following e-
mail addresses: 
coldchainteampa@almacgroup.com 
logistics@advaxis.com 
The medication contained in this shipment must not be dispensed to patients until a 
positive written feedback from Advaxis is available. 
 
Please store the affected medication separately and wait until confirmation of supply 
usability is received. 
 
No Alarm:   
If the device has been stopped and no blinking “BELL” icon is visible, verification that 
the medication was shipped under good conditions is complete.  No further actions from 
your side are necessary.  Please discard the temperature logger.  You can use the 
medication immediately. 
 
No study drug should be administered to any patients unless the TempTale has been 
reviewed and the shipment has been verified or authorized for clinical use. 
 
For questions about TempTale and drug shipment, please email the following: 
 
Almac:  
palogistics.clinicalservices@almacgroup.com 
CC: 
 
larry.haines@almacgroup.com 
  
 
logistics@advaxis.com 
 
4.1.10 Drug Accountability: All study drug must be accounted for by using the NCI Drug 
Accountability Form during the course of this study. The pharmacist or qualified research 
staff member will maintain inventory records.  The records will include details of 
materials received, the date dispensed, the patient identification number, initials of patient 
receiving the dose, and documentation of drug destruction following notification from the 
Sponsor or completion/termination of the study.  It is the Investigator’s responsibility to 
arrange for disposal of all empty containers, provided that procedures for proper disposal 
have been established according to applicable federal, state, local and institutional 
guidelines and procedures, and provided that appropriate records of disposal are kept. 
(06/27/2016) 
 
4.1.11 Drug Destruction: All investigational product can be discarded in accordance with the 
Institution’s policies for Biohazard Waste Disposal or by using the steps shown below for 
ADXS11-001 destruction. (06/27/2016) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 31 - 
 
 
  
The used or unused vials of ADXS11-001 can be treated with a 10% bleach solution for 
disinfection.  Use a 10% solution of Clorox (or any similar commercial chlorine bleach 
solution containing 5.25% sodium hypochlorite (NaClO) for disinfection.  (03/09/2015)  
 
1. 
Treat unopened or opened vials(s) with a minimum volume of 0.25 mL of bleach 
solution to sterilize its contents. 
2. 
Empty the disinfected chemical solution in drain, run water to remove residual 
materials from drain and discard empty vials into designated biohazardous waste 
container, as applicable. 
3. 
The residual IV bags or other components used for preparing the drug product 
should also be inactivated with bleach and discarded in similar manner as 
explained in steps 1 and 2.  
 
4.1.12   Accidental Spills:  All accidental spills shall be handled in compliance with applicable 
site safety procedures or following the guidance below: 
 
In the event there is an accidental spill of ADXS11-001, isolate the area and 
notify others in the vicinity. 
 
Put on appropriate personal protective equipment (PPE) if not already worn (e.g. 
gown or lab coat, gloves and loose fitting mask with eye shield or goggles). 
 
Remove any broken glass or sharps and place them into sharps container. 
 
Place paper tower over the spill 
 
Saturate the paper-towel(s) with bleach starting at the outside of the spill and 
working towards the center. Allow the 10% bleach solution to remain on area for 
approximately 10 min.  
 
Dispose the paper towel(s) in a biohazardous waste container. 
 
Clean the remaining disinfectant with additional paper towels, as needed. 
 
Discard all materials including PPEs, in the designated biohazardous waste 
container(s). 
 
Inform the Principal Investigator (PI) and other appropriate personnel, e.g. 
Research Manager, Pharmacy Manager.  
 
4.1.13 Exposure to ADXS11-001:  All exposure incidences shall be handled in compliance with 
applicable site safety procedures or following the guidance below: 
 
In the event of an accidental exposure, remove and dispose of contaminated PPEs or 
clothing into the designated biohazardous waste containers. 
 
For skin contamination:  thoroughly wash the affected area immediately with soap and 
water. 
For needle stick injury:  wash the affected area thoroughly with soap and water and cover 
the area with a sterile gauze dressing.  Notify the PI who will determine appropriate 
medical actions to be taken. 
 
For eye contamination: immediately and thoroughly rinse the affected area for up to 15 
minutes using an eyewash; making the water flow across the affected eye from the nose 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 32 - 
 
to the outer corner of the eye. If only one eye is contaminated, avoid contaminating the 
other eye (position your head so the affected eye must be below the other eye). Notify PI 
who will determine appropriate medical actions to be taken. 
 
It will be the investigator’s responsibility to ensure that procedures for proper disposal 
have been established according to applicable regulations, guidelines, and institutional 
procedures and that: 
the coordinating institution has been alerted to drug destruction and has been sent hospital 
destruction policy, if applicable  
arrangements have been made for the disposal  
appropriate records of the disposal have been documented. 
 
A separate (NCI) Drug Accountability Form must be completed for Drug 
Destruction. (12/23/2013)  
 
4.1.14 Investigator Brochure: the most current version of the ADXS11-001 investigator 
brochure can be downloaded on the GOG-0265 Web page.  If there are any questions 
pertaining to the IB, please contact: 
 
Robert Ashworth 
Advaxis Inc. 
Phone: 609-250-7508 
email: ashworth@advaxis.com (5/23/2011) (12/23/2013) (06/27/2016) 
 
4.2 
Pathology Requirements 
  
See Section 3.1 for eligibility. No Slides Required. 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 33 - 
 
5.0 
TREATMENT PLAN AND ENTRY/REGISTRATION PROCEDURE     
 
Before patient entries will be accepted, submit the following documents to the GOG 
Administrative Office via mail (Attn:  Regulatory Department, Protocol GOG-0265): 
 IRB approval* 
 IRB-approved informed consent 
 IRB Membership list or FWA assurance letter 
 Institutional Biosafety Committee (IBC) approval 
 Waiver from the BSL-2 categorization of the wild type Listeria monocytogenes 
OPTIONAL.  May be submitted by sites which restrict work with BSL-2 agents 
(10/17/2011 (05/06/2013) 
 Study-specific signed original FDA Form 1572 for institution PI**  
 Current Biographical Sketch (no more than two pages) for institution PI**  
 Current CV (signed and dated within one year) for sub-investigators listed on 
FDA Form 1572 
 Medical license for institution PI and sub-investigators listed on the FDA Form 
1572 
 Lab license, certificates, and required Normal Lab Values (NLV) for labs listed 
on FDA Form 1572 
 Signed GOG Investigator Signature Page for PI**(12/23/2013) 
 Signed GOG Financial Disclosure Form for all investigators listed on FDA Form 
1572**(12/23/2013) 
 Pharmacy Information Form** 
 
The GOG Administrative Office will receive the regulatory documents and submit them 
to Advaxis for review and approval.  Upon Advaxis approval, Advaxis will submit the PI 
Biographical Sketch, IRB approval, IRB approved informed consent and Institutional 
Biosafety Committee Approval to the NIH Office of Biotechnology Activities (OBA). No 
patient can be enrolled until the NIH OBA has received these documents.  Upon 
receipt at the NIH OBA, Advaxis will notify GOG of institution approval and GOG will 
then notify the institution that they have been regulatory approved. 
 
Please allow 7-10 days for processing of regulatory documents before screening the 
first patient. All copies of the above should be filed into a study-specific regulatory 
binder at your institution. 
 
* When submitting the IRB approval to the GOG, the CTSU IRB Certification Form 
must be used (form can be downloaded at www.ctsu.org). All initial, continuing and 
amendment reviews must be sent to the GOG Administrative Office. 
 
** Please see GOG-0265 protocol documentation page to download forms by clicking on 
the “Regulatory Forms” link. 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 34 - 
 
5.1 
Patient Entry and Registration 
 
For patients in the safety lead-in, the GOG Statistical and Data Center’s web-based 
patient reservation system (available at the GOG web menu page) will be used, in which 
slots for particular patients are reserved.  Reservations are not transferrable to other 
patients, and if the patient is not enrolled within the required timeframe, the reservation is 
then cancelled and the slot is then made available to other patients and sites.  If all slots 
are reserved, patients can be added to a waiting list for that dose level.  NOTE:  The 
safety lead-in has been completed.  (03/09/2015) 
 
All site staff will use OPEN to enroll patients to this study.  OPEN can be accessed at on 
the GOG web menu page and clicking on the OPEN link.  
  
Prior to accessing OPEN site staff should verify the following: 
  
All eligibility criteria have been met within the protocol stated timeframes. Site staff 
should use the registration forms provided on the group web site as a tool to verify 
eligibility. 
All patients have signed an appropriate consent form and HIPAA authorization form (if 
applicable).  
  
Access requirements for OPEN: 
  
Site staff will need to be registered with CTEP and have a valid and active CTEP-IAM 
account. This is the same account (user id and password) used for the CTSU members' 
web site.  
To perform registrations, the site user must have been assigned the 'Registrar' role on the 
GOG or CTSU roster.  
To perform registrations you must have an equivalent 'Registrar' role on the Lead Group 
roster.  Role assignments are handled through the Groups in which you are a member.  
  
Note:  The OPEN system will provide the site with a printable confirmation of 
registration and treatment information.   Please print this confirmation for your records.  
  
Further instructional information is provided on the CTSU members' web site OPEN tab 
or within the OPEN URL. For any additional questions contact the CTSU Help Desk at 
1-888-823-5923 or ctsucontact@westat.com.  
 
5.2 
Treatment Plan (06/27/2016) 
 
ADXS11-001 will be given at a dose of 1 x 109 cfu intravenously once every 28 days 
until clinical progression has been determined, confirmed radiologic disease progression, 
intolerable toxicity or the patient refuses further treatment.  The drug will be given as a 
250 mL infusion over 60 minutes and will be given on Day 1 of each cycle.  All subjects 
will receive a 7 day course of oral antibiotic  therapy starting approximately 72 hours 
(Day 4) after each ADXS11-001 infusion. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 35 - 
 
 
During Study Treatment Phase - All subjects will receive a 7-day course of oral antibiotic 
therapy starting approximately 72 hours (Day 4) after administration of ADXS11-001.  
Antibiotic therapy should consist of either 160 mg trimethoprim/800 mg 
sulfamethoxazole (DS) tablet administered 3 times during the 7 consecutive days or 80 
mg trimethoprim/400 mg sulfamethoxazole administered daily for 7 consecutive days.  
For subjects who develop a sulfa allergy, that precludes completion of this required 
antibiotic course, treatment with ampicillin 500 mg 4 times daily for 7 consecutive days 
should be administered.  
 
Post Study Treatment - All subjects will receive a 6-month course of oral 
trimethoprim/sulfamethoxazole (or ampicillin for subjects who develop a sulfa allergy 
that precludes completion of  the full oral trimethoprim/sulfamethoxazole course) to be 
initiated approximately 72 hours following the last dose of study treatment or at the time 
of study discontinuation.  The dose of trimethoprim/sulfamethoxazole consists of either 
160 mg trimethoprim/800 mg sulfamethoxazole (DS) tablet administered 3 times a week 
or 80 mg trimethoprim/400 mg sulfamethoxazole administered daily.  The dose of 
ampicillin consists of 500 mg 4 times daily.  Review the approved product labeling for 
trimethoprim/sulfamethoxazole and ampicillin, and monitor antibiotic tolerance as dosing 
adjustments may be necessary.   
 
The study includes a safety lead-in, in which the dose limiting toxicities of the study 
agent will be assessed in the first 6 patients enrolled.  Further accrual will be held until all 
6 patients have completed 28 day observation after cycle 1 treatment (See Section 5.3).  
 
During the safety lead in, all enrolling sites will be required to participate in a regularly 
scheduled teleconference with the Study Chair, Phase I Safety Lead-in Chair and Phase I 
Committee Chair, and their assigned delegates. Conference calls during phase II will be 
at the discretion of the Study Chair and the Chair of the Developmental Therapeutics 
Committee of the GOG. (5/23/2011) 
NOTE:  The safety lead-in has been completed (03/09/2015) 
 
Chemotherapy Guidelines:  See the GOG General Chemotherapy Guidelines (Appendix 
IV). (02/06/2012) 
 
5.2.1 Pretreatment Prophylaxis (06/27/2016) 
 
Mild to moderate flu-like symptoms and cytokine release symptoms (e.g., constitutional 
symptoms such as fever, chills, rigors, fatigue, headache, nausea, vomiting, tachycardia, 
shortness of breath, hypotension and rash) are commonly seen and typically occur 
2-4 hours after ADXS11-001 infusion and often resolve within 12-24 hours.  
Prophylactic medications are intended to reduce the inflammatory response.  Subjects 
should receive the following pretreatment prophylaxis regimen. 
 
IV Fluid Hydration: 
Normal saline (e.g., 500 mL over 30 minutes) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 36 - 
 
 
Premedication Regimen: 
Antihistamine – PO or IV (e.g. diphenhydramine 25 mg or equivalent), once 
NSAIDs - PO (e.g., naproxen 220 mg or ibuprofen, 400 mg), once 
Antiemetic - PO or IV (e.g., promethazine or ondansetron), once 
Histamine H2-receptor antagonist – PO or IV (e.g., famotidine 20 mg or equivalent), 
once 
 
Pretreatment medication should be given on the day of dosing and completed at least 
30 minutes prior to the start of the study treatment.  Additional NSAID doses and 
antiemetic administration should be given per label or package insert post initial 
administration on Day 1 and Day 2, as needed.  The prescribed dosage of the selected 
NSAID and antiemetic will be at the discretion of the Investigator. 
 
Do not substitute acetaminophen for the selected NSAID for prophylactic treatment since 
acetaminophen does not have similar anti-inflammatory properties that could ameliorate 
cytokine release symptoms. 
 
Antiemetics such as promethazine or ondansetron will continue to be given as described 
above.  Thus, subjects will leave the study site with doses of the NSAID and antiemetic 
to take later in the day, as appropriate. 
 
PLEASE SEE Section 4.1.4 for important information regarding the use of a 
temporary IV line and the placement of reminder stickers.  
 
5.2.2 ADXS11-001 Regimen (06/27/2016) 
 
5.2.2.1 Within 4 days of Day 1 of each cycle (prior to dosing with ADXS11-001) patients must 
have blood work obtained to include creatinine (See Section 7.1 for mandatory labs). 
NOTE: If creatinine > 1.5 x ULN (CTCAE v4.0 Grade 2 or higher) then dose will be held 
until recovery to Grade 1 or less. The maximum dose delay to allow for recovery is 3 
weeks. In the safety lead-in, patients whose serum creatinine is >1.5 x ULN and who do 
not recover to ≤1.5xULN and who do not complete at least 2 of the 3 planned courses 
will be replaced (up to a maximum of three replacements), unless their serum creatinine 
is >3.0 x ULN (these patients will be considered DLTs and will not be replaced).  All 
treated patients in the lead-in will be counted in the phase II efficacy evaluation. 
(5/23/2011) 
 
On Day 1, ADXS11-001 will be administered as a 60 minute intravenous infusion of 1 x 
109 cfu in 250 mL of normal saline. Treatment is to be done on an outpatient basis.  
Patients will be observed in the outpatient area for 8 hours following the ADXS11-001 
infusion.  Vital signs will be taken pre-dose, every 30 minutes (+/- 5 minutes) for the next 
4 hours and at approximately 8 hours after the infusion, as a safety measure.  Patients will 
return on Day 2 for toxicity assessment and vital signs 24 hours (+/- 2 hours) after dose.  
Patients will return Day 4 (approximately 72 hours after dosing) for toxicity assessment 
and vital signs. (10/22/2012) (12/23/2013) (03/09/2015) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 37 - 
 
 
PLEASE SEE Section 4.1.4 for important information regarding the use of a 
temporary IV line and the placement of reminder stickers. 
 
Day 1 of each treatment:  At 8 hours after the dose, the patient must have a temperature 
less than 38.5 degrees C and other vital signs (heart rate, blood pressure, and respiration) 
must be within normal limits.  The patient must not show signs or symptoms of 
moderate-severe nausea, vomiting, or headache.  If the patient does not meet these 
discharge criteria, the patient should be admitted to the hospital for observation and 
treatment of side effects.      
 
A subject who experiences a fever (CTCAE Grade 1 or greater) 24 hours following the 
completion of ADXS11-001 infusion should be started on NSAIDS, hydration and other 
appropriate measures to treat the fever. In the event that the fever persists or worsens 48 
hours following the completion of ADXS11-001 infusion then oral or broad spectrum IV 
antibiotics should be considered based on the subject’s medical condition. If the fever 
remains unresponsive to oral/IV antibiotics 72 hours following the completion of the 
infusion then a blood culture should be obtained to evaluate for listeremia and determine 
the appropriate treatment course for the subject.      
 
Should a diagnosis of listeriosis be made at any point after treatment with ADXS11-001 
and the 6-month course of oral antibiotics are completed, immediate and intensive IV 
antibiotic treatment (ampicillin +/- gentamycin or other IV antibiotic regimen as 
indicated) is required  An infectious disease consult should be obtained.  Based on each 
individual subject’s case and at the discretion of the treating physician, the removal of 
any foreign medical object that has been present since treatment with ADXS11-001 was 
initiated may be warranted.  It is extremely important that the Investigator, his/her 
research staff, other healthcare providers involved in the care of the subject as well as 
each subject participating in this study are educated and made aware of the signs and 
symptoms of listeriosis and the potential for delayed listeremia/listeriosis.  Educational 
materials for the Investigator, research staff, health care providers and subjects will be 
prepared and educational training performed. (06/27/2016) 
 
5.2.3 Safety Follow-up/Post-Treatment Visits (06/27/2016) 
 
Safety follow-up will be conducted via an office visit or telephone call at 30 days (± 5 
days) after the last ADXS11-001 infusion to confirm the resolution of any ongoing AEs 
and SAEs.  Additional unscheduled visits may be considered as needed and at the 
discretion of the Investigator.   
 
Surveillance monitoring for the detection of Lm will be initiated at the completion of 
study treatment according to the protocol or at the time of study discontinuation if earlier. 
This surveillance monitoring period will consist of a 6-month course of oral antibiotics 
and obtaining blood cultures at regular intervals.  The blood cultures will be performed 
on all subjects who have received at least 1 dose of ADXS11-001.  Blood cultures will 
occur every 3 months (±1 month) for 3 years beginning 3 months after the last dose of 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 38 - 
 
study treatment.  Patient who enter supportive care phase of illness and are no longer 
having regular blood work (e.g., hospice care) will no longer be required to have blood 
cultures performed.This testing may be performed at the investigational site or at another 
acceptable location following consultation with the Sponsor.   
 
5.3 
Dose Limiting Toxicities FOR PHASE I SAFETY LEAD_IN PORTION ONLY 
(06/27/2016) 
 
The 6 patients enrolled in the safety lead-in and the patients in the first stage of the study 
will be evaluated for Dose Limiting Toxicities (DLT) during the 28 days following the 
completion of all treatment (Day 84). DLTs are defined as either hematologic or non-
hematologic toxicities (assessed in accordance with the CTEP CTCAE Version 4), which 
cause any of the following: 
 
5.3.1 Hematologic Toxicity:  
 
5.3.1.1 Dose delay of greater than 3 weeks due to failure to recover counts.  
 
5.3.1.2 Study treatment-related febrile neutropenia.  
 
5.3.1.3 Grade 4 neutropenia lasting > 7 days.  
 
5.3.1.4 Study treatment-related Grade 4 thrombocytopenia or bleeding associated with Grade 3 
thrombocytopenia.  
 
5.3.2 Non-Hematologic Toxicity:  
 
5.3.2.1 Study treatment-related Grade 3 or Grade 4 non-hematological toxicity excluding 
alopecia and fatigue. 
 
5.3.2.2 Documented bacterial meningitis 
 
5.3.2.2 Clinical sepsis requiring ICU admission and/or pressors 
 
5.3.2.3 Documented persistent listeremic event (defined by a positive blood culture for Listeria at 
greater than or equal to 72 hours after dosing). (5/23/2011) 
 
5.3.2.4 Grade 3 or 4 hypotension sufficient to warrant therapeutic intervention 
 
5.3.2.5 Grade 3 or 4 nausea, vomiting, constipation, or diarrhea is not a DLT unless there is no 
resolution to Grade 1 or less despite adequate medical intervention.  
 
5.3.2.6 Grade 3 or 4 transaminitis is not a DLT unless there is no resolution to Grade 1 or less in 
less than or equal to 7 days 
 
5.3.3 Treatment delay of greater than 14 days. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 39 - 
 
5.3.4 Any drug-related death 
 
5.4 
Concurrent Therapies and Procedures (06/27/2016) 
 
All prescription and nonprescription medication (excluding vitamins, nutritional 
supplements and hormone replacement therapy) taken by the subject from screening and 
up to and including completion of the 30 day post treatment safety follow-up will be 
recorded in the medical record and on the CRF.  Any addition, deletion, or change in the 
dose of these medications will also be recorded.  Generic names should be used to 
eliminate confusion that may result from trade names.  Protocol-mandated prophylactic 
medications, antibiotics and procedures administered/performed following the 
completion of study treatment, including during the 30 day post treatment safety follow-
up period, should also be captured on the CRF. The 6 month antibiotic accountability 
details during the Lm Surveillance period should be captured on the CRF. 
 
Study subjects should be reminded that acetaminophen should not be used for 
pretreatment prophylaxis associated with the foreseeable AEs related to the study 
treatment since this medication can interfere with treatment. 
 
Medications specifically prohibited in the exclusion criteria are not allowed during the 
ongoing trial.  If there is a clinical indication for one of these or other medications 
specifically prohibited during the trial, discontinuation from trial therapy may be 
required.  The Investigator should discuss any questions regarding this with the Sponsor.  
The final decision on any supportive therapy rests with the Investigator and/or the 
subject’s primary physician.  However, the decision to continue the subject’s on-trial 
therapy requires the mutual agreement of the Investigator, the Sponsor, and the subject. 
 
Subjects are prohibited from receiving the following therapies during the screening and 
treatment phases of this trial: 
 
Anti-cancer systemic chemotherapy, targeted therapy or biological therapy 
 
Surgical anti-cancer treatment.  The sponsor should be notified of any emergency 
surgeries that occur and prior to planned elective surgeries. 
 
PI3K inhibitors and TNF blocking agents 
 
Immunotherapy not specified in this protocol 
 
Investigational agents other than ADXS11-001 
 
Radiation therapy (except palliative radiation therapy for disease-related pain with 
a consult with the sponsor's medical monitor) 
 
Live vaccines within 30 days prior to the first dose of trial treatment and while 
participating in the trial.  Examples of live vaccines include, but are not limited to, 
the following:  measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, 
and typhoid (oral) vaccine.  Seasonal influenza vaccines for injection are 
generally killed virus vaccines and are allowed; however, intranasal influenza 
vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed. 
 
Acetaminophen is not to be used for premedication but may be used for 
supportive care measures. NSAIDs, such as naproxen and ibuprofen have been 
evaluated and are confirmed not to interfere with efficacy. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 40 - 
 
 
Subjects who, in the assessment by the Investigator, require the use of any of the 
aforementioned treatments for clinical management should be removed from the trial.  
Subjects may receive other medications that the Investigator deems to be medically 
necessary. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 41 - 
 
6.0 
TREATMENT MODIFICATIONS AND SUPPORTIVE CARE (5/23/2011) 
(06/27/2016)   
 
The dose of ADXS11-001 will not be modified (e.g., reduced or increased).  However, 
treatment may be delayed or discontinued for toxicities, as shown in the table below. 
 
NOTE:  Any patients with a treatment delay of > 3 weeks will not receive any further 
ADXS11-001 treatment. 
 
Please note all CTCAE grading below refers to version 4.0. (02/062012) 
 
 
Treatment Delay/Discontinuation Guidelines for Drug Related Adverse Events 
Toxicity 
Grade 
Hold treatment 
Timing for 
restarting treatment 
Discontinue 
Treatment 
Hematologic 
1,2,3 
No  
N/A 
N/A 
4 
Yes 
Toxicity resolves to 
≤Grade 1 or baseline 
Toxicity does not 
resolve to ≤Grade 1 
or baseline within 3 
weeks 
Non-
hematologic, 
excluding 
cytokine release 
symptoms and 
DLTs 
1 
No 
N/A 
N/A 
2-3 
Yes 
Toxicity resolves to 
≤Grade 1 
Toxicity not 
resolved to ≤Grade 
1 within 3 weeks of 
last infusiona 
4 
N/A 
Permanent treatment 
discontinuation 
Permanent 
Discontinuation 
from Treatment 
a With investigator and sponsor agreement, subjects with a non-hematologic  AE (e.g. alopecia, neuropathy) still at grade 2 after 
3 weeks, may continue treatment if only asymptomatic and controlled. 
 
 
6.1 
Additional Guidelines for the Management of Hematologic Toxicity (06/27/2016) 
 
6.1.1 Initial treatment modifications will consist of cycle delay as indicated in the above table.  
The use of hematopoietic cytokines and protective reagents are restricted as noted: 
(02/06/2012) 
 
6.1.1.1 Patients will NOT receive prophylactic G-CSF. 
 
6.1.1.2 Patients will NOT receive prophylactic thrombopoietic agents. 
 
6.1.1.3 Patients may receive erythropoietin (EPO), iron supplements, and/or transfusions as 
clinically indicated for management of anemia. Treating physicians should be aware of 
the recent changes in prescribing information for the erythropoiesis stimulating agents 
(including Aranesp, Epogen and Procrit) which note that there is a potential risk of 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 42 - 
 
shortening the time to tumor progression or disease-free survival, and that these agents 
are administered only to avoid red blood cell transfusions. They do not alleviate fatigue 
or increase energy. They should not be used in patients with uncontrolled hypertension. 
They can cause an increased incidence of thrombotic events in cancer patients on 
chemotherapy. The updated package inserts should be consulted.   
http://www.fda.gov/Medwatch/safety/2007/safety07.htm 
 
6.2 
Supportive Care Guidelines (06/27/2016) 
 
The major safety findings with ADXS11-001 occurring in >5% of subjects, as of 
February 2015 (n=230) and being possibly, probably or definitely related include 
anaemia (7.8%), chills (33.9%), fatigue (11.7%), fever (24.8%), nausea (20.4%), 
vomiting (13.5%), headaches (15.7%), and hypotension (6.5%).  Most are Grade 1-2 in 
severity.  Subjects should receive appropriate supportive care measures as deemed 
necessary by the treating Investigator including but not limited to the items outlined 
below. 
 
6.2.1 Cytokine Release Symptoms are a constellation of inflammatory symptoms resulting 
from cytokine elevations associated with T cell engagement and proliferation.  Symptoms 
related to cytokine release may include constitutional symptoms such as fever, chills, 
rigors, fatigue, headache, nausea, vomiting, rash, tachycardia, hypotension and shortness 
of breath which usually presents several hours after the infusion and lasts for up to 
24 hours.  These symptoms are caused by an increase in cytokines such as TNFα, IFNγ 
and IL-6, all of which have been shown to occur after ADXS11-001 administration, 
resulting from the body’s immune response to the therapy.  Although, symptoms are 
often Grade 1-2 and transient, resolving with symptomatic management within 
30 minutes to 1 hour, in rare instances (~1%) Grade 3-4 hypotension has been seen.  
Therefore, close monitoring of blood pressure is strongly recommended at baseline, and 
during the post-infusion period.  Increased levels of IL-6 have been strongly associated 
with capillary leak which manifests as hypotension due to the cytokines involved.  We 
have observed elevated IL-6 levels after infusion of ADXS11-001, with peak levels 
occurring 2-4 hours after infusion.  Emerging evidence indicates that IL-6 antagonists, 
such as tocilizumab, have demonstrated good results in treating cytokine-induced 
hypotension65-68 and are therefore recommended for cases of severe hypotension 
refractory to supportive care (e.g., fluids and/or pressors). 
 
The management of cytokine release symptoms and guidelines for subsequent treatment 
modifications for subjects who have experienced these AEs are shown in the table below. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 46 - 
 
Recommended Management Guidelines for Adverse Events Associated with Cytokine Release  
Toxicity 
NCI 
CTCAE 
Grade or 
Severity 
Treatment 
Modification for Subsequent infusions 
Hypotension 
1 
Mild 
Supportive care 
Increase pretreatment IV fluids (e.g., 500 ml -1L normal 
saline) 
All other cytokine release 
symptoms (e.g. chills, rigors, 
fever, nausea, vomiting) 
1 
Supportive care 
No modification 
Hypotension 
 
2 
Moderate 
Fluids and 1 dose of pressor (e.g. 0.3 mg epinephrine 
IM)  
Increase monitoring of vital signs 
If hypotension persist for more than one hour 
consider low dose corticosteroids (e.g. 
hydrocortisone 100 mg IV) 
Extend infusion time to 2 hours.  
Increase pretreatment IV fluids (e.g. 500 ml -1L normal 
saline)  
Incorporate Glucocorticoid- Hydrocortisone or equivalent- 
50 mg, IV, as premedication 
 
All other cytokine release 
symptoms (e.g. chills, rigors, 
fever, nausea, vomiting) 
2 
Appropriate supportive care measure 
Extend infusion time to 2 hours.  
Consider increasing doses of prophylactic medications 
Hypotension 
3 
Severe 
Fluids, high dose pressors (e.g. Dopamine 10 
µg/kg/min)  +1 dose tocilizumab*(4mg/kg over 1 
hour) 
If hypotension worsens or is unresponsive to above 
measures, administer corticosteroids 
If the subject’s condition does not improve or 
stabilize within 24 hours of the tocilizumab dose, 
administration of a second dose of tocilizumab +/- 
corticosteroids should be considered. 
Discuss with Sponsor 
All other cytokine release 
symptoms (e.g. chills, rigors, 
fever, nausea, vomiting) 
3 
Appropriate supportive care  measures 
Extend infusion time to 2 hours.  
Consider increasing doses of prophylactic dose of NSAID, 
or antiemetic as appropriate 
Hypotension/ 
4 
Vigilant supportive care 
Permanently discontinue 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 47 - 
 
Recommended Management Guidelines for Adverse Events Associated with Cytokine Release  
Toxicity 
NCI 
CTCAE 
Grade or 
Severity 
Treatment 
Modification for Subsequent infusions 
Organ toxicity, mechanical 
ventilation 
Life 
threatening 
Fluids 
High dose  pressors,  
Tocilizumab (4mg/kg over 1 hour) +/- 
corticosteroids (hydrocortisone 100 mg IV infused 
over 30 seconds administered every 2 hours until 
symptoms resolve to <Grade 1) 
* Tocilizumab is a humanized, immunoglobulin G1k (IgG1k) anti-human IL-6R mAb approved for treatment of adult subjects with moderately to severely active rheumatoid 
arthritis (RA) who have had an inadequate response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs), for the treatment of active polyarticular juvenile idiopathic arthritis 
(PJIA), and active systemic juvenile idiopathic arthritis (SJIA) in subjects 2 years of age and older.  Tocilizumab works by preventing IL-6 binding to both cell-associated and 
soluble IL-6Rs. Although, it is not indicated for the treatment of cytokine release symptoms emerging clinical experience at several institutions has concluded that tocilizumab is an 
effective treatment for severe or life-threatening cytokine release symptoms.65-68 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 48 - 
 
 
6.2.2 Nausea and vomiting should be treated aggressively.  In addition to the prophylactic 
antiemetic therapy subjects receive prior to each infusion, consideration should be given 
to subsequent administration of antiemetic therapy every 8 hours, as needed according to 
standard institutional practice.  Subjects should also be strongly encouraged to maintain 
liberal oral fluid intake.  
 
6.2.3 Hypersensitivity/Anaphylaxis/Infusion Site Extravasation:  
While there is some overlap between infusion reactions symptoms and cytokine release 
symptoms, infusion reactions symptoms typically occur during the infusion, while 
cytokine release symptoms typically occur after the infusion and are mediated by a 
different mechanism of action.  Signs/symptoms of infusion reactions may include: 
allergic reaction/hypersensitivity (including drug fever); arthralgia (joint pain); 
bronchospasm; cough; dizziness; dyspnea (shortness of breath); fatigue (asthenia, 
lethargy, malaise); headache; hypertension; hypotension; myalgia (muscle pain); nausea; 
pruritic/itching; rash/ desquamation; rigors/chills; sweating (diaphoresis); tachycardia; 
tumor pain (onset or exacerbation of tumor pain due to treatment); urticaria (hives, welts, 
wheals); and vomiting. 
 
The table below shows the management guidelines for subjects who experience an 
infusion reaction associated with administration of ADXS11-001. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 49 - 
 
Recommended Management Guidelines for Infusion Reactions 
NCI CTCAE Grade 
Management 
Grade 1 
 
Mild reaction; infusion interruption 
not indicated; intervention not 
indicated 
Increase monitoring of vital signs as medically indicated until the 
subject is deemed medically stable in the opinion of the 
Investigator. 
Grade 2 
 
Requires infusion interruption but 
responds promptly to symptomatic 
treatment (e.g., antihistamines, 
NSAIDS, narcotics, IV fluids); 
prophylactic medications indicated 
for ≤24 hrs. 
Stop Infusion and monitor symptoms. 
Additional appropriate medical therapy may include but is not 
limited to: 
IV fluids 
Antihistamines 
NSAIDS 
Acetaminophen 
Narcotics 
Increase monitoring of vital signs as medically indicated until the 
subject is deemed medically stable in the opinion of the 
Investigator. 
If symptoms resolve within one hour of stopping drug infusion, 
the infusion may be restarted at 50% of the original infusion rate.  
Otherwise dosing will be held until symptoms resolve and the 
subject should be premedicated for the next scheduled dose. 
Grades 3 or 4 
 
Grade 3: 
Prolonged (i.e., not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms following 
initial improvement; 
hospitalization indicated for other 
clinical sequelae (e.g., renal 
impairment, pulmonary infiltrates) 
 
Grade 4: 
Life-threatening; pressor or 
ventilatory support indicated 
Stop Infusion. 
Additional appropriate medical therapy may include but is not 
limited to: 
IV fluids 
Antihistamines 
NSAIDS 
Acetaminophen 
Narcotics 
Oxygen 
Pressors 
Corticosteroids 
Epinephrine 
Increase monitoring of vital signs as medically indicated until the 
subject is deemed medically stable in the opinion of the 
Investigator. 
Hospitalization may be indicated. 
Subjects who experience a Grade 4 reaction should be 
permanently discontinued from study. Subjects who experience a 
grade 3 reaction may be discontinued. Discussion with the 
Sponsor is recommended 
 
6.3 
Listeriosis and Listeria Infection – Identification and Management (06/27/2016) 
 
A person with (wt) listeriosis usually presents with fever and muscle aches, sometimes 
preceded by diarrhea or other gastrointestinal symptoms.  Almost everyone who is 
diagnosed with listeriosis has an "invasive" infection, in which the bacteria spread 
beyond the gastrointestinal tract.  The symptoms vary with the infected person.  Pregnant 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 50 - 
 
women typically experience fever and other non-specific symptoms, such as fatigue and 
aches.  However, infections during pregnancy can lead to miscarriage, stillbirth, 
premature delivery, or life-threatening infection of the newborn.  In people other than 
pregnant women, symptoms can include headache, stiff neck, confusion, loss of balance, 
and convulsions in addition to fever and muscle aches.  Listeriosis can present in 
different ways.  In older adults and people with immunocompromising conditions, 
septicemia and meningitis are the most common clinical presentations.69  Subjects may 
need immediate evaluation with a brain CT scan or MRI and a lumbar puncture with the 
analysis of spinal fluid to rule out meningitis. 
 
For symptomatic subjects, diagnosis is confirmed only after isolation of Lm from a 
normally sterile site, such as blood or spinal fluid (in the setting of nervous system 
involvement), or amniotic fluid/placenta (in the setting of pregnancy).  Stool samples are 
of limited use and are not recommended.  Lm can be isolated readily on routine media, 
but care must be taken to distinguish this organism from other Gram-positive rods, 
particularly diphtheroids.  Selective enrichment media improve rates of isolation from 
contaminated specimens.  You can expect that the cultures will take approximately 1-2 
days for growth.  Importantly, a negative culture does not rule out infection in the 
presence of strong clinical suspicion.  Serological tests are unreliable, and not 
recommended at the present time.69 
 
Listeriosis is treated with a wide range of antibiotics.  In preclinical studies, wt-Lm and 
ADXS11-001 are susceptible to the lowest tested concentration of the following 
antimicrobial agents:  ampicillin, amoxicillin/K clavulanate, ciprofloxacin, erythromycin, 
gentamicin, penicillin, tetracycline, trimethoprim/sulfamethoxazole and vancomycin 
(IV).  ADXS11-001 is resistant to both streptomycin and chloramphenicol. 
 
6.3.1 Management and Surveillance of Listeria during Study Participation  
 
In the event a subject experiences a persistent fever lasting 72 hours after receiving study 
treatment then the oral antibiotic regimen will be replaced by broad spectrum IV 
antibiotic treatment.  If symptoms consistent with sepsis occur close to ADXS11-001 
administration or at any time after ADXS11-001 administration, immediate medical 
attention must be sought.  A microbial culture will be taken to identify the agent of sepsis 
and antibiotic sensitivity testing should be performed to confirm susceptibility.  An 
infectious disease consult should be obtained for further management of these subjects.   
 
All subjects will receive a 6-month course of an oral antibiotic regimen as a prophylactic 
measure following the completion of the last dose of ADXS11-001 treatment or at the 
time of study discontinuation.  This additional safety measure is intended to eradicate Lm 
from the body. 
 
Lm surveillance monitoring will also be initiated following the completion of the last 
dose of ADXS11-001 treatment or at the time of study discontinuation. This monitoring 
will blood cultures for the detection of Listeria.  Testing will be performed on all subjects 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 51 - 
 
who have received at least 1 dose of ADXS11-001 and occur every 3 months (±1 month) 
for 3 years beginning 3 months after the last dose of study treatment. 
Should a diagnosis of listeriosis be made at any point after treatment with ADXS11-001 
and the 6-month course of oral antibiotics are completed, immediate and intensive IV 
antibiotic treatment (ampicillin +/- gentamycin or other IV antibiotic regimen as 
indicated) is required  An infectious disease consult should be obtained.  Based on each 
individual subject’s case and at the discretion of the treating physician, the removal of 
any foreign medical object that has been present since treatment with ADXS11-001 was 
initiated may be warranted.  It is extremely important that the Investigator, his/her 
research staff, other healthcare providers involved in the care of the subject as well as 
each subject participating in this study are educated and made aware of the signs and 
symptoms of listeriosis and the potential for delayed listeremia/listeriosis.  Educational 
materials for the Investigator, research staff, health care providers and subjects will be 
prepared and educational training performed. 
 
6.4 
Major and Minor Surgeries and ADXS11-001 Treatment (06/27/2016) 
 
No formal studies of the effect of ADXS11-001 on wound healing have been conducted.  
However, based on its mechanism of action it is not expected that administration of 
ADXS11-001 would complicate wound healing.  Therefore, a subject may initiate or 
resume study treatment 2 weeks after minor surgery (i.e., surgery involving little risk to 
the life of the subject; specifically an operation on the superficial structures of the body 
or a manipulative procedure that does not involve a serious risk) if the wound has 
completely healed and there are no wound healing complications.  A subject who has 
wound healing complications following minor surgery, received major surgery or 
requires new implants and/or devices (permitted by the protocol) during the course of the 
study, must wait a minimum of 6 weeks and must have recovered from any toxicity 
(e.g., return to baseline or Grade 1) and/or complication before the next infusion of study 
treatment.  Sponsor consultation is required prior to resuming study treatment for these 
subjects.  If the treatment is delayed due to concomitant surgery beyond 12 weeks, the 
subject may be discontinued from the study. 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 52 - 
 
7.0 
STUDY PARAMETERS   
 
7.1 
Observations and Tests 
 
The following observations and tests are to be performed and recorded on the appropriate 
form(s): (5/23/2011) (02/06/2012) (06/27/2016) 
 
 
Parameter 
 
 
Pre-
Therapy 
Day 1 of 
each 
cycle 
Day 2 of 
each cycle 
(24 hours 
post 
dosing) 
Days 3&4 of 
each cycle for 
first 6 patients 
and Day 4 for all 
other patients (72 
hours post 
dosing) 
Off of all 
study 
therapy11 
 
History & Physical 
1, 2 
X# 
X# 
X# 
 
Performance Status 
1 
X# 
X# 
X# 
 
Toxicity Assessment  
3 
X# 
X# 
X# 
X 
Prior/Concomitant 
Medications 
3 
X 
 
 
 
Non Drug 
Treatment/Procedures 
2, 3 
X 
X 
X 
X 
Vital signs (Blood 
pressure, temperature, 
pulse, respiratory 
rate). 
1 
10 
10 
10 
 
CBC/Differential/ 
Platelets 
3 
 4, 5 
 
 
 
Electrolytes, BUN, 
creatinine, Ca, Mg, 
PO4 
3 
 4, 5 
 
 
 
Bilirubin, AST, ALT, 
Alkaline Phosphatase 
3 
 4, 5 
 
 
 
Lm Surveillance 
Monitoring 
 
 
 
 
6 
Urinalysis 
3 
4 
(05/06/2013) 
 
 
 
Serum pregnancy test 
(for patients capable 
of childbearing) 
9 
 
 
 
 
Chest imaging (X-ray 
or CT of the chest) 
1 
 
 
 
7 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 53 - 
 
Radiographic tumor 
measurement (of the 
abdomen and pelvis) 
1 
 
 
 
8 
 
# The first 6 patients will have a daily History and Physical, Performance Status, Toxicity 
Assessment, and Vital Signs for four days of each cycle. All other patients will have a History 
and Physical, Performance Status on Day 1 only and Toxicity Assessment and Vital Signs on 
Days 1, 2, and 4 of each cycle.  NOTE:  The safety lead-in has been completed. (03/09/2015) 
 
Notes: 
1. Must be obtained within 28 days prior to initiating protocol therapy.  
2. History includes medical, prior cancer and surgical histories.  Surgical history includes documentation 
of non-cancer surgeries, including, but not limited to artificial (prosthetic) joints, implants and/or devices, 
such as port/stent implant placed prior to study enrollment. 
3. Must be obtained within 14 days prior to initiating protocol therapy. 
4. If grade 4 neutropenia is documented (ANC <500/mcl) obtain twice per week until grade 3 or less. If 
grade 3 or 4 AST, ALT, alkaline phosphatase, total bilirubin, or creatinine obtain twice per week until 
resolved to grade 1 or less.  
5. Must be obtained within 4 days of re-treatment with protocol therapy.  
6 Lm surveillance will includes a 6 month post ADS11-001 oral antibiotic treatment to mitigate the risk of 
delayed listeria infection and routine monitoring of blood cultures.  Following completion of study 
treatment blood cultures will be performed every 3 months (±1 month) for 3 years beginning 3 months 
after the subject’s last dose of study treatment. 
7. Repeat chest-x-ray if initially abnormal or if required to monitor tumor response. Chest-x-ray is not 
required if a chest CT is performed as part of the tumor measurement.  
8. First follow-up CT scan should be at 12 weeks (provided patient remains clinically stable) then every 8 
weeks for first 6 months and then every 3 months thereafter, until patient is put on non-protocol therapy. 
(5/23/2011)  
Patients with progressive disease (irPD) detected before or at the 12-week imaging assessment, but 
without rapid clinical deterioration, require confirmation of irPD with a second, consecutive scan 
obtained ≥ 4 weeks from the initial documentation. Patients will continue to receive study treatment until 
irPD is confirmed at this later time point. (See section 8.2.) (10/22/2012) (03/09/2015)  
9. Obtain within 48 hours prior to patient enrolling into study.  
10. Patients will be observed in the chemotherapy outpatient area for 8 hours following the ADXS11-001 
infusion. Vital signs will be taken pre-dose, every 30 minutres (+/- 5 minutes) for 4 hours after dose, 
approximately 8 hours after dose, 24 hours (+/- 2hours)  and 72 hours (Day 4) after dose.  
11. Follow-up is every three months for the first 3 years and every 6 months for the next 2 years (see 
Section 9). (5/23/2011)  
 
7.2 
Pathology Requirements: (02/06/2012)  
 Pathology report for histologic confirmation of primary tumor 
 Pathology report for recurrent or persistent disease if histologically documented  
 Slides not required- no Central Pathology Review 
 All reports should be mailed to the GOG SDC in Buffalo, NY or uploaded via 
SEDES. 
 
7.3  
Translational Research 
 
7.3.1 Specimen Requirements (05/23/2011) (10/17/2011) (10/22/2012) (05/06/2013) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 54 - 
 
 
If the patient gives permission for her specimens to be used for translational research, then the 
participating institution is required to submit the patient’s specimens as outlined below. 
 
A detailed description of the specimen requirements can be found in Appendix I.   
Required Specimen (Specimen Code) 
Collection Time Point 
Ship To 
FFPE Primary Tumor (FP01)* 
1st Choice: block 
2nd Choice: 15 unstained slides (charged, 5µm)  
Prior to all treatment 
Ship to the GOG Tissue Bank 
within 8 weeks of registration1 
 
 
FFPE Metastatic Tumor (FM01)* 
1st Choice: block 
2nd Choice: 15 unstained slides (charged, 5µm) 
Optional if FP01or FR01  
is submitted 
 
Prior to all treatment 
FFPE Recurrent Tumor (FR01)* 
1st Choice: block 
2nd Choice: 15 unstained slides (charged, 5µm) 
Optional if FP01or FM01  
is submitted 
 
Prior to starting ADXS11-
001 
Pre-Dose 1 Serum (SB01) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
Prior to dose 1 of 
ADXS11-001 
Ship to the GOG Tissue Bank 
within 2 weeks of study entry1 
 
 
2 Hour Post-Dose 1 Serum (SB02) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
2 hours after dose 1 of 
ADXS11-001 
8 Hour Post-Dose 1 Serum (SB03) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
8 hours after dose 1 of 
ADXS11-001 
24 Hour Post-Dose 1 Serum (SB04) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
24 hours after dose 1 of 
ADXS11-001 
Pre-Dose 2 Serum (SB05) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
Prior to dose 2 of 
ADXS11-001 
Ship to the GOG Tissue Bank 
within 6 weeks of study entry1 
 
 
2 Hour Post-Dose 2 Serum (SB06) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
2 hours after dose 2 of 
ADXS11-001 
8 Hour Post-Dose 2 Serum (SB07) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
8 hours after dose 2 of 
ADXS11-001 
24 House Post-Dose 2 Serum (SB08) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
24 hours after dose 2 of 
ADXS11-001 
Pre-Dose 3 Serum (SB09) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
Prior to dose 3 of 
ADXS11-001 
Ship to the GOG Tissue Bank 
within 10 weeks of study 
entry1 
 
 
2 Hour Post-Dose 3 Serum (SB10) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
2 hours after dose 3 of 
ADXS11-001 
8 Hour Post-Dose 3 Serum (SB11) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
8 hours after dose 3 of 
ADXS11-001 
24 Hour Post-Dose 3 Serum (SB12) 
prepared from 7-10mL of blood drawn into a 
plain red top tube 
24 hours after dose 3 of 
ADXS11-001 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 55 - 
 
* 
A copy of the corresponding pathology report must be shipped with all tissue specimens sent to the GOG 
Tissue Bank. 
1 
Ship specimens as described in Appendix I to: GOG Tissue Bank / Protocol GOG-0265, Nationwide 
Children’s Hospital, 700 Children’s Drive, WA1340, Columbus, OH 43205, Phone: 614-722-2865, Fax: 614-722-
2897, Email: gogbank@nationwidechildrens.org (12/23/2013) 
 
7.3.2 Laboratory Testing 
7.3.2.1 Serum Cytokines 
Serum specimens will be batch shipped to Advaxis. Serum specimens will be used to 
assess the concentrations of IFN-γ and IL-2, as the flu-like response to ADXS11-001 is 
presumed to be mediated by the release of cytokines into the systemic circulation. 
(5/23/2011) 
7.3.2.2 HPV Typing 
 
Unstained slides will be shipped to Advaxis for HPV testing and genotyping. (5/23/2011) 
7.3.3 Future Research 
Details regarding the banking and use of specimens for future research can be found in 
Appendix I.  
7.4 
Quality of Life 
 
Not applicable. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 56 - 
 
8.0 
EVALUATION CRITERIA   
 
8.1 
Antitumor Effect – Solid Tumors (10/22/2012) 
 
In this study, disease parameters (section 8.11) and methods for tumor evaluation 
(Section 8.12)--but not evaluation of tumor response--will be in accordance with the 
Response Evaluation Criteria in Solid Tumors (RECIST) guideline Version 1.1.[69]  
RECIST 1.1 response criteria are primarily designed to evaluate the early effects of 
cytotoxic agents, and depend on tumor shrinkage to demonstrate biologic activity. 
However, clinical evidence of tumor responses seen with immunotherapeutic agents such 
as ADXS11-001 can take longer to achieve, and may occur after a period of disease 
stabilization or following an initial increase in tumor burden. In light of the limitations of 
utilizing RECIST1.1 to evaluate immunomodulatory agents, immune-related response 
criteria (irRC) have been proposed to systematically detect the novel response patterns 
observed with immunologic agents.70  Therefore, in this study, tumor response will be 
evaluated with an irRC modification of RECIST v1.1. (See also Section 8.2). 
(06/27/2016) 
8.1.1 Disease Parameters  
 
Measurable disease:  Measurable lesions are defined as those that can be accurately 
measured in at least one dimension (longest diameter to be recorded) as >10 mm with CT 
scan, as >20 mm by chest x-ray, or >10 mm with calipers by clinical exam.  All tumor 
measurements must be recorded in decimal fractions of centimeters. 
 
Note:  Tumor lesions that are situated in a previously irradiated area will not be 
considered measurable unless progression is documented or a biopsy is obtained to 
confirm persistence at least 90 days following completion of radiation therapy. 
 
Malignant lymph nodes:  To be considered pathologically enlarged and measurable, a 
lymph node must be >15 mm in short axis when assessed by CT scan (CT scan slice 
thickness recommended to be no greater than 5 mm).  At baseline and in follow-up, only 
the short axis will be measured and followed. 
 
Non-measurable disease:  All other lesions (or sites of disease), including small lesions 
(longest diameter <10 mm or pathological lymph nodes with ≥ 10 to <15 mm short axis), 
are considered non-measurable disease.  Leptomeningeal disease, ascites, 
pleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast disease, 
and abdominal/pelvic masses (identified by physical exam and not CT or MRI), are 
considered as non-measurable. 
 
Notes:   
Bone lesions:  Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft 
tissue components, that can be evaluated by CT or MRI can be considered as measurable 
lesions if the soft tissue component meets the definition of measurability described 
above.  Blastic bone lesions are non-measurable. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 57 - 
 
 
Cystic lesions that meet the criteria for radiographically defined simple cysts should not 
be considered as malignant lesions (neither measurable nor non-measurable) since they 
are, by definition, simple cysts.  “Cystic lesions” thought to represent cystic metastases 
can be considered as measurable lesions, if they meet the definition of measurability 
described above. However, if non-cystic lesions are present in the same patient, these are 
preferred for selection as target lesions. 
 
 Target lesions:  All measurable lesions up to a maximum of 2 lesions per organ and 5 
lesions in total, representative of all involved organs, should be identified as target 
lesions and recorded and measured at baseline.  Target lesions should be selected on the 
basis of their size (lesions with the longest diameter), be representative of all involved 
organs, and in addition should be those that lend themselves to reproducible repeated 
measurements.  It may be the case that, on occasion, the largest lesion does not lend itself 
to reproducible measurement, in which circumstance the next largest lesion which can be 
reproducibly measured should be selected.  A sum of the diameters (longest for non-
nodal lesions, short axis for nodal lesions) for all target lesions will be calculated and 
reported as the baseline sum diameters.  If lymph nodes are to be included in the sum, 
then only the short axis is added into the sum.  The baseline sum diameters will be used 
as reference to further characterize any objective tumor regression in the measurable 
dimension of the disease. 
 
Non-target lesions:  All other lesions (or sites of disease), including any measurable 
lesions over and above the 5 target lesions should be identified as non-target lesions and 
should also be recorded at baseline.  Measurements of these lesions are not required, but 
the presence, absence, or in rare cases unequivocal progression of each should be noted 
throughout follow-up.  
 
8.1.2 Methods for Evaluation of Disease: 
 
All measurements should be taken and recorded in metric notation using a ruler or 
calipers.  All baseline evaluations should be performed as closely as possible to the 
beginning of treatment and never more than 4 weeks before the beginning of the 
treatment. 
 
The same method of assessment and the same technique should be used to characterize 
each identified and reported lesion at baseline and during follow-up. Imaging-based 
evaluation is preferred to evaluation by clinical examination unless the lesion(s) being 
followed cannot be imaged but are assessable by clinical exam. 
 
Clinical lesions: Clinical lesions will only be considered measurable when they are 
superficial (e.g., skin nodules and palpable lymph nodes) and 10 mm diameter as 
assessed using calipers (e.g., skin nodules).  In the case of skin lesions, documentation by 
color photography, including a ruler to estimate the size of the lesion, is recommended.  
 
Chest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they are 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 58 - 
 
clearly defined and surrounded by aerated lung.  However, CT is preferable.  
 
Conventional CT and MRI: This guideline has defined measurability of lesions on CT 
scan based on the assumption that CT slice thickness is 5 mm or less.  If CT scans have 
slice thickness greater than 5 mm, the minimum size for a measurable lesion should be 
twice the slice thickness.  MRI is also acceptable in certain situations (e.g., for body 
scans), but NOT lung.   
 
Use of MRI remains a complex issue.  MRI has excellent contrast, spatial, and temporal 
resolution; however, there are many image acquisition variables involved in MRI, which 
greatly impact image quality, lesion conspicuity, and measurement.  Furthermore, the 
availability of MRI is variable globally.  As with CT, if an MRI is performed, the 
technical specifications of the scanning sequences used should be optimized for the 
evaluation of the type and site of disease.  Furthermore, as with CT, the modality used at 
follow-up should be the same as was used at baseline, and the lesions should be 
measured/assessed on the same pulse sequence.  It is beyond the scope of the RECIST 
guidelines to prescribe specific MRI pulse sequence parameters for all scanners, body 
parts, and diseases.  Ideally, subsequent image acquisitions should use the same type of 
scanner and follow the baseline imaging protocol as closely as possible.  If possible, body 
scans should be performed with breath-hold scanning techniques. 
 
FDG-PET/CT: At present, the low-dose or attenuation correction CT portion of a 
combined PET-CT is not always of optimal diagnostic CT quality for use with RECIST 
measurements.  However, FDG-PET/CT may be used in this study if the CT portion of 
this study is a diagnostic quality CT with contrast (oral and IV) allowing for tumor 
measurements. If it is not of diagnostic quality, a diagnostic CT scan must be done.  
While FDG-PET/CT scan response assessments need additional study, it is reasonable to 
incorporate the use of FDG-PET/CT scanning to complement CT scanning in tumor 
assessment. If a post-baseline FDG-PET/CT scan shows evidence of a new lesion, 
progressive disease must be confirmed ≥ four weeks later by CT scan, and classification 
of progressive disease will be made based on irRECIST criteria below. (10/22/2012) 
 
Note:  A “positive” FDG-PET scan lesion means one that is FDG avid with an uptake 
greater than twice that of the surrounding tissue on the attenuation corrected image. 
 
Ultrasound: Ultrasound is not useful in assessment of lesion size and should not be used 
as a method of measurement.  Ultrasound examinations cannot be reproduced in their 
entirety for independent review at a later date and, because they are operator dependent, it 
cannot be guaranteed that the same technique and measurements will be taken from one 
assessment to the next.  If new lesions are identified by ultrasound in the course of the 
study, confirmation by CT or MRI is advised.  If there is concern about radiation 
exposure at CT, MRI may be used instead of CT in selected instances. 
 
Endoscopy, Laparoscopy: The utilization of these techniques for objective tumor 
evaluation is not advised.  However, such techniques may be useful to confirm complete 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 59 - 
 
pathological response when biopsies are obtained or to determine relapse in trials where 
recurrence following complete response (CR) or surgical resection is an endpoint. 
 
Cytology, Histology: These techniques can be used to differentiate between partial 
responses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in tumor 
types, such as germ cell tumors, where known residual benign tumors can remain). 
 
It is mandatory to obtain cytological confirmation of the neoplastic origin of any effusion 
that appears or worsens during treatment when measureable disease has met criteria for 
response or stable disease.  This confirmation is necessary to differentiate response or 
stable disease versus progressive disease, as an effusion may be a side effect of the 
treatment. 
 
8.1.3 Response Criteria  (RECIST 1.1) (10/22/2012) 
 
THIS SECTION IS FOR REFERENCE ONLY. Refer to Section 8.2 for response 
criteria to be used in this study. 
Determination of response should take into consideration all target (See 8.131) and non-
target lesions (See 8.132) and if appropriate, biomarkers (See 8.133). (06/27/2016) 
 
8.1.3.1 Evaluation of Target Lesions 
 
Complete Response (CR): Disappearance of all target lesions.  Any pathological lymph 
nodes (whether target or non-target) must have reduction in short axis to <10 mm. 
 
Partial Response (PR):  At least a 30% decrease in the sum of the diameters of target 
lesions, taking as reference the baseline sum diameters. 
 
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target 
lesions, taking as reference the smallest sum on study (this includes the baseline sum if 
that is the smallest on study).  In addition to the relative increase of 20%, the sum must 
also demonstrate an absolute increase of at least 5 mm. PD must be confirmed after 3-4 
weeks in the absence of clinical deterioration. (Note:  the appearance of one or more 
small new lesions is not considered progression if when added to total tumor burden it 
does not increase by 20%). PD need not be confirmed if accompanied by other evidence 
of clinical deterioration (decreasing performance status, organ function, other clinical 
impression). (5/23/2011) 
 
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase 
to qualify for PD, taking as reference the smallest sum diameters while on study 
 
Not evaluable (NE): When at least one target lesion is not evaluated at a particular time 
point. 
 
8.1.3.2 Evaluation of Non-Target Lesions 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 60 - 
 
Complete Response (CR): Disappearance of all non-target lesions.  All lymph nodes must 
be non-pathological in size (<10 mm short axis) 
 
Non-CR/Non-PD: Persistence of one or more non-target lesion(s) 
 
Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal 
progression of existing non-target lesions.  Unequivocal progression should not normally 
trump target lesion status.  It must be representative of overall disease status change, not 
a single lesion increase and be considered with the total tumor burden. (5/23/2011) 
 
Not evaluable (NE): When at least one non-target lesion is not evaluated at a particular 
time point. 
 
Although a clear progression of only “non-target” lesions is exceptional, the opinion of 
the treating physician should prevail in such circumstances, and the progression status 
should be confirmed at a later time by the review panel (or Principal Investigator). 
 
8.1.3.3 Evaluation of Biomarkers 
 
 
Biomarker measurements are not used to determine response or progression in this study. 
 
8.1.3.4 Evaluation of Best Overall (unconfirmed) Response 
 
The best overall response is the best time point response recorded from the start of the 
treatment until disease progression/recurrence (taking as reference for progressive disease 
the smallest sum recorded since baseline).  The patient's best response assignment will 
depend on the achievement of both measurement and confirmation criteria in some 
circumstances.   
 
Time Point Response for Patients with Measurable Disease at baseline (i.e., Target 
Disease) 
Target 
Lesions 
Non-Target 
Lesions 
New 
Lesions* 
Time Point  
Response 
CR 
CR 
No 
CR 
CR 
Non-CR/Non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-PD or NE 
No 
PR 
SD 
Non-PD or NE 
No 
SD 
NE 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD** 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
 
*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion  
** In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as disease 
progression. 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 61 - 
 
Time Point Response for Patients with only Non-Measurable Disease at baseline 
(i.e., Non-Target Disease) 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.1.3.5 Best Overall Confirmed Response  
 
Confirmation of CR and PR for determination of best overall response is required for 
studies with a primary endpoint that includes response. 
 
Confirmed CR and PR for best overall confirmed response 
 
Time Point Response 
First time point 
Time Point Response 
Subsequent time point 
BEST overall confirmed 
response 
CR 
CR 
CR 
CR 
PR 
SD, PD or PR* 
CR 
SD 
SD provided minimum criteria for SD 
duration met, otherwise, PD 
CR 
PD 
SD provided minimum criteria for SD 
duration met, otherwise, PD 
CR 
NE 
SD provided minimum criteria for SD 
duration met, otherwise, NE 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SD 
SD  
PR 
PD 
SD provided minimum criteria for SD 
duration met, otherwise, PD 
PR 
NE 
SD provided minimum criteria for SD 
duration met, otherwise, NE 
NE 
NE 
NE 
*If a CR is truly met at first time point, then any disease seen at a subsequent time point, 
even disease meeting PR criteria relative to baseline, makes the disease PD at that point 
(since disease must have reappeared after CR).  However, sometimes ‘CR’ may be 
claimed when subsequent scans suggest small lesions were likely still present and in fact 
the patient had PR or SD, not CR at the first time point. Under these circumstances, the 
original CR should be changed to PR or SD and the best response is PR or SD.   
 
Non-Target 
Lesions 
New 
Lesions* 
Time Point 
Response 
CR 
No 
CR 
Non-CR/non-PD 
No 
Non-CR/non-PD** 
NE 
No 
NE 
Unequivocal PD* 
Yes or No 
PD 
Any 
Yes 
PD 
 
*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion  
 
**  ‘Non-CR/non-PD’ is preferred over ‘stable disease’ for non-target disease since 
SD is increasingly used as an endpoint for assessment of efficacy in some trials so to 
assign this category when no lesions can be measured is not advised 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 62 - 
 
In non-randomized trials where response is part of the primary endpoint, confirmation of 
CR or PR is needed to deem either one the “best overall response.”   Responses (CR and 
PR) require confirmation at greater than or equal to 4 weeks from initial documentation. 
 
For this study, the minimum criteria for SD duration is 6 weeks. 
 
Patients with a global deterioration of health status requiring discontinuation of treatment 
or die without objective evidence of disease progression at that time should be reported to 
be off study treatment due to “symptomatic deterioration.”  Every effort should be made 
to document the objective progression even after discontinuation of treatment. 
 
8.2 
Response Assessment:  Immune-Related RECIST (10/22/2012) 
 
As previously noted, this study will assess tumor response with an immune-related 
modification of RECIST 1.1 (see Table 8.2-1 below). 
Determination of response via irRECIST should take into consideration all target and 
non-target lesions.  
A key distinction between standard RECIST 1.1 criteria and immune-related response 
criteria is that irRECIST requires early evidence of progressive disease (i.e., a 
determination of irPD ≤ 12 weeks after starting study treatment) be confirmed by repeat, 
consecutive imaging ≥ 4 weeks after the initial documentation in the absence of rapid 
clinical deterioration. During this interim ≥ 4 week period, patients should continue to be 
followed per protocol, including continued dosing of the study drug(s). 
Additionally, the immune-mediated responses expected from ADXS11-001 require 
activation of the immune system prior to the observation of clinical responses, and such 
immune activation may take weeks to months to be clinically evident. Some patients with 
advanced cancer may have objective volume increase of tumor lesions within 12 weeks 
following the start of dosing on study. Such patients may not have had sufficient time to 
develop the required immune activation or, in some patients, tumor volume increases 
may represent infiltration of lymphocytes into the original tumor. In traditional oncology 
studies, such increases in tumor volume during the first 12 weeks of the study would 
constitute progressive disease and lead to discontinuation of study treatment and of 
imaging to detect response, thus disregarding the potential for subsequent immune-
mediated clinical response. Therefore, in this study, the first imaging assessment will be 
performed at Week 12, followed by assessment every 8 weeks thereafter.  
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 63 - 
 
Table 8.2-1 
Tumor Response Evaluation:  Comparison Between RECIST 1.1 and 
irRECIST  
* Patients with an initial finding of progressive disease (irPD) before or at the 12 
week imaging assessment, but without rapid clinical deterioration, require 
confirmation of irPD with a second, consecutive scan obtained ≥ 4 weeks from the 
initiation documentation. Patients will continue to receive study treatment until 
irPD is confirmed at this later time point. Best overall response (BOR) will therefore 
include responses occurring at any time before disease progression and after early 
progression (i.e., within the first 12 weeks of the study). 
8.2.1 Response in Measurable Lesions 
At baseline, the sum of the longest diameters (SumD) of all target lesions (up to 2 lesions 
per organ, up to total 5 lesions) is measured. At each subsequent tumor assessment (TA), 
the SumD of the target lesions and of new, measurable lesions (≥ 10 mm [lymph nodes 
≥ 15 mm in shortest diameter]; up to 2 new lesions per organ, total 5 new lesions) are 
added together to provide the total measurable tumor burden (TMTB): 
TMTB = SumD target lesions + SumD new, measurable lesions 
Percentage changes in TMTB per assessment time-point describe the size and growth 
kinetics of both old and new, measurable lesions as they appear. At each TA, the 
Criteria 
RECIST1.1 
irRECIST 
New measurable 
lesions (≥10 mm) 
Always represents PD 
Incorporated into tumor burden 
New non-measurable 
lesions (< 10 mm) 
Always represents PD 
Does not define progression but 
precludes irCR 
Non-Target lesions 
Changes contribute to defining BOR of 
CR, PR, SD, and PD 
Contribute to defining irCR 
(complete disappearance required) 
CR 
Disappearance of all lesions 
Disappearance of all lesions 
PR 
≥ 30% decrease in the sum of the 
longest diameter of all target lesions 
compared with baseline, in absence of 
new lesions or unequivocal 
progression of non-target lesions 
≥ 30% decrease in tumor burden 
compared with baseline 
SD 
Neither sufficient shrinkage to qualify 
for PR nor sufficient increase to 
qualify for PD, taking as reference the 
smallest sum diameters while on study 
Neither a 30% decrease in tumor 
burden compared with baseline nor a 
20% increase compared with nadir 
can be established 
PD 
At least 20% increase in sum of 
diameters of target lesions, taking as 
reference the smallest sum on study. In 
addition to the relative increase of 
20%, the sum must also demonstrate 
an absolute increase of at least 5mm. 
The appearance of one or more new 
lesions is also considered progression. 
At least 20% increase in tumor 
burden compared with nadir (at any 
single time point)* 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 64 - 
 
response in target and new, measurable lesions is defined based on the change in TMTB 
(after ruling out irPD) as follows: 
Complete Response (irCR): Complete disappearance of all target and new, measurable 
lesions, with the exceptions of lymph nodes which must decrease to < 10 mm in short 
axis 
Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline (see below). 
Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD. 
Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir. 
8.2.2 Response in Non-measurable Lesions 
At each TA, the presence of any new, non-measurable lesions is assessed. The presence 
of such lesions will rule out an overall response of irCR. An increase in the size or 
number of new, non measurable lesions does not necessarily imply an overall response of 
irPD; if these lesions become measurable (≥ 10 mm) at a subsequent TA, their 
measurement will at that point start to contribute to the TMTB. 
In addition, the response in non-target lesions is defined as follows: 
Complete Response (irCR): Complete disappearance of all non-target lesions 
Stable Disease (irSD): Non-target lesions are stable 
Progressive Disease (irPD): Unequivocal increases in number or size of non-target 
lesions. To achieve unequivocal progression of non-target lesions, there must be an 
overall level of substantial worsening of non-target disease that is of a magnitude that the 
treating physician would feel it is important to change therapy. 
NOTE:  Equivocal findings of progression of non-target lesions (e.g., small and uncertain 
new lesions; cystic changes or necrosis in existing lesions) should be considered irSD, 
and treatment may continue until the next scheduled assessment.  
8.2.3 Evaluation of Biomarkers 
None. 
8.2.4 Overall Response 
The OR according to the irRC is derived from the responses in measurable lesions (based 
on TMTB) as well as the presence of any non-measurable lesions as follows: 
Complete Response (irCR): Complete disappearance of all lesions (whether measurable 
or not); lymph nodes must decrease to < 10 mm in shortest dimension. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 65 - 
 
Partial Response (irPR): Decrease in TMTB ≥ to 30% relative to baseline. 
Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD. 
Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir. 
The immune-related best overall response (irBOR) is the best irRC OR over the study as 
a whole, recorded between the date of first dose until the last TA prior to subsequent 
therapy (including tumor resection surgery) for the individual patient in the study. As 
with the primary definitions of tumor response, early progression (i.e., irPD occurring 
prior to Week 12) will not preclude an irBOR of irCR, irPR or irSD resulting from the 
Week 12 assessment. An assessment of irPD at or after Week 12 will preclude a 
subsequent irBOR of irCR, irPR or irSD. However, any post-progression clinical activity 
in subjects with irBOR of irPD may be summarized for exploratory purposes. 
Table 8.2-2 
Best Overall Response (irBOR) 
Target Lesions 
Baseline (Index) and  
New Measurable Lesions 
Non-Target Lesions* 
irRC Overall 
Response 
Total Measurable Tumor Burden 
(TMTB) 
Baseline 
Lesions 
Unequivocal 
New Lesions 
irCR 
irCR 
No 
irCR 
irCR 
irSD 
No 
irPR 
irPR 
irCR or irSD 
No 
irPR 
irSD 
irCR or irSD 
No 
irSD 
irPD 
Any 
Yes or No 
irPD 
Any 
Unequivocal 
Progression 
Yes or No 
irPD 
Any 
Any 
Yes 
irPD 
*NOTE: Any increase in the size or number of non-measurable lesions does not 
necessarily imply an overall response of irPD. If these lesions become measurable (≥ 
10 mm) at a subsequent TA, their measurement will at that point start to contribute 
to the TMTB. To achieve unequivocal progression of non-target lesions, there must 
be an overall level of substantial worsening in non-target disease that is of a 
magnitude that the treating physician would feel it is important to change therapy. 
Equivocal findings of progression of non-target lesions (e.g., small and uncertain 
new lesions; cystic changes or necrosis in existing lesions) should be considered 
irSD, and treatment may continue until the next schedule assessment. 
8.3 
Duration of Response (10/22/2012) 
 
Duration of overall response:  The duration of overall response is measured from the time 
measurement criteria are met for irCR or irPR (whichever is first recorded) until the first 
date that recurrent or progressive disease (irPD) is objectively documented (taking as 
reference for progressive disease the smallest measurements recorded since the treatment 
started). 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 66 - 
 
 
The duration of overall irCR is measured from the time measurement criteria are first met 
for irCR until the first date that irPD is objectively documented. 
 
 
Duration of stable disease:  Stable disease is measured from the start of the treatment 
until the criteria for irPD are met. (02/06/2012) 
 
8.4 
Recurrence (10/22/2012) 
 
Recurrence is defined as newly evident disease for patients who have no evidence of 
disease at baseline or progressive disease for patients who have strictly non-measurable 
disease at baseline.   
 
8.5 
Recurrence-Free Survival (10/22/2012) 
 
Recurrence-Free Survival (RFS) is defined as the duration of time from study entry to 
time of recurrence or death, whichever occurs first. 
 
 
8.6 
Progression-Free Survival (10/22/2012) 
 
Progression-Free Survival (PFS) is defined as the duration of time from study entry to 
time of progression or death, whichever occurs first. 
 
8.7 
Survival (10/22/2012) 
 
Survival is defined as the duration of time from study entry to time of death or the date of 
last contact. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 67 - 
 
9.0 
DURATION OF STUDY    
 
9.1 
Patients will continue treatment until disease has progressed and been confirmed or 
progressed in the setting of clinical deterioration or intolerable toxicity intervenes.  The 
patient can refuse the study treatment at any time. (5/23/2011) (03/09/2015) 
 
9.2 
Patients will be followed (with physical exams and histories) every three months for the 
first three years and then every six months for the next two years.  Patients will be 
monitored for delayed toxicity and survival for this 5 year period with Q forms submitted 
to the GOG Statistical and Data Center, unless consent is withdrawn. (5/23/2011) 
(06/27/2016) 
 
9.3 
Surveillance monitoring for the detection of Lm will be initiated at the completion of 
study treatment according to the protocol or at the time of study discontinuation if earlier. 
This surveillance monitoring period will consist of a 6-month course of oral antibiotics 
and blood cultures at regular intervals.  This surveillance monitoring will be performed 
on all subjects who have received at least 1 dose of ADXS11-001.  Blood cultures will 
occur every 3 months (± 1 month) for 3 years beginning 3 months after the last dose of 
study treatment.  This testing may be performed at the investigational site or at another 
acceptable location following consultation with the Sponsor. (06/27/2016) 
 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 68 - 
 
10.0 
STUDY MONITORING AND REPORTING PROCEDURES   
 
10.1 
IND Sponsor: Advaxis Inc., IND #13,712 
 
10.2 
ADVERSE EVENT REPORTING FOR AN INVESTIGATIONAL AGENT (5/23/2011) 
(03/09/2015) (06/27/2016) 
 
Timely and complete reporting of safety information assists Advaxis in identifying any 
untoward medical occurrence, thereby allowing:  (1) the protection of the safety of study 
subjects, (2) a greater understanding of the overall safety profile of ADXS11-001, (3) 
recognition of dose-related ADXS11-001 toxicities, (4) appropriate modification of study 
protocols, (5) improvements in study design or procedures, and (6) adherence to 
worldwide regulatory requirements.   
 
All Investigators have the primary responsibility for AE identification, documentation, 
grading, and assignment of attribution to the study treatment.  It is the responsibility of 
the Investigator to supply the medical documentation needed to support expedited AE 
reports in a timely manner. 
 
Adverse events (AEs) will be reported to FDA according to 21 CFR 312.32. 
   
10.2.1 Definition of Adverse Events (AE) 
 
Adverse event (AE):  any untoward medical occurrence in a subject or clinical 
investigation subject administered a pharmaceutical product and which does not 
necessarily have to have a causal relationship with this treatment.  An AE can therefore 
be any unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease temporally associated with the use of a medicinal product 
or protocol-specified procedure, whether or not considered related to the medicinal 
product or protocol-specified procedure.  Any worsening (i.e., any clinically significant 
adverse change in frequency and/or intensity) of a preexisting condition that is temporally 
associated with the use of study treatment (ADXS11-001 or Placebo) is also an AE. 
 
AE(s) may also occur in screened subjects during any pre-allocation baseline period as a 
result of a protocol-specified intervention, including washout or discontinuation of usual 
therapy, diet, placebo treatment or a procedure. 
 
AEs may occur during the course of the use of Advaxis’ product in clinical trials or 
within the follow-up period specified by the protocol, or prescribed in clinical practice, 
from overdose (whether accidental or intentional), from abuse and from withdrawal. 
 
All AEs will be recorded from the time the consent form is signed through 30 days 
following cessation of treatment during the study treatment period of the study.   
 
Progression of the cancer under study is not considered an AE unless it results in 
hospitalization or death. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 69 - 
 
 
If known, the diagnosis of the underlying illness or disorder should be recorded, rather 
than its individual symptoms.  The following information should be captured for all AEs:  
onset and end dates, severity (grade of the event), Investigator’s opinion of the 
relationship to ADXS11-001 (see definitions below), treatment/action required for the 
AE, and information regarding resolution/outcome. 
 
Overdose:  any dose exceeding the prescribed dose by 100%.  No specific information is 
available on the treatment of overdose of ADXS11-001.  In the event of an overdose, the 
subject should be observed closely for signs of toxicity.  Appropriate supportive 
treatment should be provided if clinically indicated.  If an AE(s) results from the 
overdose of ADXS11-001, the AE is reported as a SAE(s), even if no other seriousness 
criteria are met.  An overdose without any associated clinical symptoms or abnormal 
laboratory results is reported as an AE. 
 
AEs and other symptoms will be graded according to the expanded NCI CTCAE v 4.0.  
All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. 
A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site 
(http://ctep.cancer.gov). The CTCAE v4.0 Manual is also available on the GOG member 
web site (http://www.gog.org under MANUALS). 
 
10.2.1.1 
Evaluating Adverse Events 
 
An Investigator who is a qualified physician will evaluate all AEs according to the NCI 
CTCAE v 4.0.  Any AE that changes CTCAE grade over the course of a given episode 
will have each change of grade recorded on the CTEP-AERS report. 
 
When possible, AEs should be described in terms of a change in the baseline status or 
with a diagnosis or summary term rather than as individual symptoms. 
 
Criteria for Determining AE Severity:  The descriptions and grading scales found in the 
revised NCI CTCAE v 4.0 will be utilized for AE reporting. 
 
Criteria for Determining AE Causality:  The following attribution categories must be 
used in assessing the relationship between the AE and the study treatment: If the 
Investigator does not know whether or not the investigational agent caused the event, 
then the event will be handled as “related to investigational agent”. 
 
RELATIONSHIP ATTRIBUTION 
DESCRIPTION 
Unrelated to 
investigational 
agent/intervention 
Unrelated 
The AE is clearly NOT related to the study treatment 
Unlikely 
The AE is doubtfully related to the study treatment 
Related to 
investigational 
agent/intervention 
Possible 
The AE may be related to the study treatment 
Probable 
The AE is likely related to the study treatment 
Definite 
The AE is clearly related to the study treatment 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 70 - 
 
 
 
10.2.1.2 
Reporting Abnormal Test Findings 
 
The criteria for determining whether an abnormal test finding should be reported as an 
AE are as follows: 
 
 
Test result is associated with accompanying symptoms; and/or 
 
Test result requires additional diagnostic testing or medical/surgical intervention: 
and/or 
 
Test result leads to a change in study dosing or discontinuation from the study, 
significant additional concomitant drug treatments, or other; and or 
 
Test result is considered to be an AE by the Investigator or sponsor 
 
Merely repeating an abnormal test, in the absence of any of the above conditions does not 
constitute an AE.  An abnormal test result that is determined to be an error does not 
require reporting as an AE. 
 
10.2.1.3 
Reporting Cytokine Release Syndrome 
 
As per NCI CTCAE v 4.03, CRS is defined as a disorder characterized by nausea, 
headache, tachycardia, hypotension, rash, and shortness of breath.  Subjects must have 
experienced ALL symptoms for an AE to be documented as CRS.  Individual symptoms 
associated with CRS should not be reported as CRS, but should be reported as separate 
AEs. 
 
10.2.1.4 
Adverse Event Follow-Up 
 
AEs and SAEs related to ADXS11-001 (definitely, probably or possibly) should be 
followed to resolution or stabilization and reported as SAEs if they become serious.  This 
also applies to subjects experiencing AEs that cause interruption or discontinuation of 
ADXS11-001 or those experiencing AEs that are present at the end of their participation 
in the study; such subjects should receive post treatment follow-up as appropriate.  If an 
ongoing AE changes in its severity or in its perceived relationship to ADXS11-001, an 
amendment to the CTEP-AERS report  should be submitted. 
 
10.2.2 Reporting Expedited Adverse Events 
 
Depending on the phase of the study, use of investigational agents, and role of the 
pharmaceutical sponsor, an expedited AE report may need to reach multiple destinations.  
For patients participating on a GOG trial, all expedited AE reports should be submitted 
by using the CTEP Adverse Event Reporting System (AERS).  All reports are reviewed 
by GOG before final submission to CTEP-AERS. Submitting a report through CTEP-
AERS serves as notification to GOG, and satisfies the GOG requirements for expedited 
AE reporting.  All adverse reactions will be immediately directed to the Study Chair for 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 71 - 
 
further review.   Additionally, all CTEP-AERS reports for this study will be sent to 
the GOG Phase I Committee Chair and the GOG Safety Review Committee Chair. 
 
The requirement for timely reporting of adverse events to the study sponsor is specified 
in the Statement of Investigator, Form FDA-1572.  In signing the FDA-1572, the 
investigator assumes the responsibility for reporting AEs to the study sponsor.  In 
compliance with FDA regulations, as contained in 21 CFR 312.64, AEs should be 
reported by the investigator. 
 
10.2.3 Phase 1, 2 and 3 Studies:  Expedited Reporting Requirements for Adverse Events that 
Occur on Studies under a non-CTEP IND/IDE within 30 Days of the Last Administration 
of the Investigational Agent.   
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 72 - 
 
Phase 1, 2 and 3 Studies:  Expedited Reporting Requirements for Adverse Events that Occur on Studies 
under a non-CTEP IND/IDE within 30 Days of the Last Administration of the Investigational 
Agent/Intervention 1, 2  
FDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) 
NOTE:  Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they 
are considered related to the investigational agent(s)/intervention (21 CFR 312.64) 
An adverse event is considered serious if it results in ANY of the following outcomes:   
Death 
A life-threatening adverse event  
An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for ≥ 24 hours  
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions  
A congenital anomaly/birth defect.  
Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be 
considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH 
E6). 
 
ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to GOG via CTEP-
AERS within 24 hours of learning of the AE, followed by a complete report within 3 calendar days of the initial 24-
hour report. 
Hospitalization 
Grade 1 and Grade 2 Timeframes 
Grade 3-5 Timeframes 
Resulting in 
Hospitalization  
≥ 24 hrs 
24-Hour 3 Calendar Days 
24-Hour 3 Calendar Days 
Not resulting in 
Hospitalization  
≥ 24 hrs 
Not required 
 
Expedited AE reporting timelines are defined as: 
“24-Hour; 3 Calendar Days” - The AE must initially be reported via CTEP-AERS within 24 hours of learning of the 
AE, followed by a complete expedited report within 3 calendar days of the initial 24-hour report. 
 
1Serious adverse events that occur more than 30 days after the last administration of investigational agent/intervention 
and have an attribution of possible, probable, or definite require reporting as follows:  
Expedited 24-hour notification followed by complete report within 3 calendar days for: 
All Grade 3, 4, and Grade 5 AEs 
Grade 1 and 2 AEs resulting in hospitalization or prolongation of hospitalization 
NOTE: Deaths clearly due to progressive disease should NOT be reported via CTEP-AERS but rather should be 
reported via routine reporting methods (e.g., CDUS and/or CTMS). 
    2 For studies using PET or SPECT IND agents, the AE reporting period is limited to 10 radioactive half lives,   
rounded UP to the nearest whole day, after the agent/intervention was last administered.  Footnote “1” above applies 
after this reporting period. 
 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 73 - 
 
Additional Instructions or Exceptions to CTEP-AERS Expedited Reporting: 
 
In addition to the standard SAE expedited reporting criteria, the following adverse events 
also require  CTEP-AERS reporting, regardless of attribution: 
 
Bacterial meningitis ≥ grade 3 with or without hospitalization 
 
Hypotension ≥ grade 3 with or without hospitalization 
 
Sepsis ≥ grade 4 with or without hospitalization 
 
Acute and delayed listeria infection 
 
Please refer to the ADXS11-001 Investigator Brochure for information regarding adverse 
effects when determining expectedness of an event for the purpose of expedited reporting 
via CTEP-AERS. 
 
10.2.4 Procedures for Expedited Adverse Event Reporting: 
 
10.2.4.1 CTEP-AERS Expedited Reports: Expedited reports are to be submitted using CTEP-
AERS available at http://ctep.cancer.gov. The CTEP, NCI Guidelines: Adverse Event 
Reporting Requirements for expedited adverse event reporting requirements are also 
available at this site.  
 
AML/MDS events must be reported via CTEP-AERS (in addition to routine AE reporting 
mechanisms). In CTCAE v4.0, the event(s) may be reported as either: 1) Leukemia 
secondary to oncology chemotherapy, 2) Myelodysplatic syndrome, or 3) Treatment 
related secondary malignancy. 
 
In the rare event when Internet connectivity is disrupted a 24-hour notification is to be 
made to the GOG Regulatory Affairs Department by telephone at 215-854-0770.  An 
electronic report MUST be submitted immediately upon re-establishment of internet 
connection. Please note that all paper CTEP-AERS forms have been removed from the 
CTEP website and will NO LONGER be accepted. 
 
10.2.5 Reporting to Advaxis:  The GOG Regulatory Department will forward the CTEP-AERS 
report to Advaxis for all serious adverse events (SAEs) within 24 hours of discovery or 
notification of the event.  
 
Advaxis PV CRO:   inVentiv Health Clinical Pharmacovigilance  
Attn:   
 
iHC SAE Reporting (email:  i3drugsafetyPV@inventivhealth.com 
or FAX: 
 
866-880-9343) 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 74 - 
 
10.3 
GOG DATA MANAGEMENT FORMS 
The following forms must be completed and submitted to the GOG Statistical and Data 
Center (SDC) in accordance with the schedule below.  All forms except the BDR Form 
must be submitted via the SDC Electronic Data Entry System (SEDES) which is 
available through the GOG website (www.gogstats.org).  The BDR Form should be 
submitted via mail.  The GOG Uploader Application in SEDES is an alternate method for 
submitting pathology reports and BDR to the GOG SDC. (5/23/2011)   
Form (10/22/2012) 
Due within 
Copies* 
Comments 
Weeks 
Event 
Form R (Registration Form) 
 
2 
Registration 
1 
 
Mandatory 
Submission via SEDES 
Specimen Consent Application 
1 
Registration 
N/A 
Complete online 
Form OHR (Recurrent 
Gynecologic Cancer – On Study 
History Form) 
2 
Registration 
1 
Mandatory Submission via 
SEDES 
Form DR (Pre-Treatment 
Summary Form) 
 
4 
Registration 
1 
Mandatory Submission via 
SEDES 
Form BDR (Pre-Treatment Body 
Diagram Form) 
4 
Registration 
1 
 
Submit to SDC via postal 
mail or upload online via 
SEDES 
Form irRECIST (Immune 
Related RECIST Form) baseline 
4 
Registration 
1 
Mandatory Submission via 
SEDES  
 
Primary disease:** 
Pathology Report 
 
Recurrent or Persistent 
Disease:** 
Pathology Report (only if 
histologically documented) 
6 
 
 
 
 
6 
Registration 
 
 
 
 
Registration 
1** 
 
 
 
 
1** 
Submit to SDC via postal 
mail or via report uploader 
in SEDES 
Concomitant Medications Form 
(06/27/2016) 
4 
Registration 
1 
Mandatory Submission 
via SEDES 
Form D2R (Cycle Dose Drug 
Form) 
 
2*** 
Completion of each 
cycle of therapy 
1 
 
Mandatory Submission via 
SEDES 
Form irRECIST (Immune 
Related RECIST FORM)  
2 
Clinical response 
assessment 
1 
Mandatory Submission via 
SEDES 
 
Form T (Common Toxicity 
Reporting Form) 
2*** 
Beginning of each 
subsequent cycle 
1 
 
Mandatory Submission via 
SEDES 
 
 
Form Q0 (Treatment Completion 
Form) 
 
2 
Completion of study Rx 
and change in Rx 
1 
Mandatory Submission via 
SEDES 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 75 - 
 
Form Q (Follow-Up Form) 
 
2 
Disease progression; 
death; normal follow-up 
1 
Mandatory Submission via 
SEDES 
quarterly for 2 years, semi-
annually for 3 more years 
Form SP-FP01-0265**** 
for FFPE primary tumor 
(05/06/2013) 
8 
Registration 
N/A 
Submit via SEDES† 
Form SP-FM01-0265**** 
for FFPE metastatic tumor 
(optional) (05/06/2013) 
8 
Registration 
N/A 
Submit via SEDES† 
Form SP-FR01-0265**** 
for FFPE recurrent tumor 
(optional) (05/06/2013) 
8 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB01-GOG-0265 
for pre-dose 1 serum 
2 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB02-GOG-0265 
for 2 hour post-dose 1 serum 
2 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB03-GOG-0265 
for 8 hour post-dose 1 serum 
2 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB04-GOG-0265 
for 24 hour post-dose 1 serum 
2 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB05-GOG-0265 
for pre-dose 2 serum 
6 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB06-GOG-0265 
for 2 hour post-dose 2 serum 
6 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB07-GOG-0265 
for 8 hour post-dose 2 serum 
6 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB08-GOG-0265 
for 24 hour post-dose 2 serum 
6 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB09-GOG-0265 
for pre-dose 3 serum 
10 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB10-GOG-0265 
for 2 hour post-dose 3 serum 
10 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB11-GOG-0265 
for 8 hour post-dose 3 serum 
10 
Registration 
N/A 
Submit via SEDES† 
Form SP-SB12-GOG-0265 
for 24 hour post-dose 3 serum 
10 
Registration 
N/A 
Submit via SEDES† 
* 
The number of required copies including the original form which must be sent to the Statistical and Data 
Center. 
** 
Pathology slides for Central Pathology Committee Review are not required on this study. 
*** 
For patients in the safety lead-in, the T and D2R forms are due within 72 hours after completing each cycle. 
**** A copy of the corresponding pathology report must be shipped with all tissue specimens sent to the GOG 
Tissue Bank. (05/06/2013) 
† 
Form SP must be submitted online via SEDES regardless of whether the specimen is submitted for 
research. (05/06/2013) 
 
This study will be monitored by the Abbreviated Clinical Data Update System (CDUS) Version 
3.0 Cumulative CDUS data will be submitted quarterly to CTEP by electronic means.  Reports 
are due January 31, April 30, July 31 and October 31. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 76 - 
 
11.0 
STATISTICAL CONSIDERATIONS   
 
The primary objective of this study is to assess the tolerability, toxicity, and efficacy of 
the study agent, ADXS11-001, in patients with recurrent or persistent cervical cancer.  
The primary measure of efficacy will be overall survival at 12 months. 
 
We note here that the change in treatment regimen from stage 1 (three cycles of 
treatment) to stage 2 (unlimited cycles) complicates the interpretation of the trial. Under 
the reasonable but not certain assumption that extended treatment (i.e., >3 doses) is more 
effective than 3 doses: at the end of the study, if we reject the null hypothesis of 
inactivity, then we can conclude that the extended regimen is effective. (03/09/2015)  
 
11.1 
This is a single-arm, two-stage Phase II study, and no randomization is involved; 
however, patient registration will be accomplished in the usual fashion. For patients in 
the safety lead-in, patient entry will be accomplished via the GOG Statistical and Data 
Center’s Phase I reservation and registration system. 
 
11.2 
The principle parameters to be employed to evaluate the primary and secondary 
objectives are: 
 
11.2.1 Primary Endpoints: 
 
11.2.1.1 
Number of patients with DLTs. 
 
11.2.1.2 
Frequency and severity of adverse effects as assessed by CTCAE v 4.0. 
 
11.2.1.3  
The proportion of patients who survive for at least 12 months 
 
11.2.2 Secondary Endpoints: 
11.2.2.1 
Distribution of overall survival 
 
11.2.2.2 
Distribution of progression-free survival  
 
11.2.2.3 
The proportion of patients who have objective tumor response (complete or 
partial)  
 
11.2.3 Exploratory Endpoints: 
 
11.2.3.1 
Changes in clinical immunology based upon serum and their relationship with 
clinical response 
 
11.3 
Of the 25 patients enrolled in stage 2 11 patients were still on treatment at the time the 
clinical hold went into effect. It is clear that the latter patients should be replaced because 
they did not receive treatment per protocol (i.e., until progression).  However, including 
just patients who had progressed or died or who had otherwise come off study treatment, 
while excluding patients still on treatment at the time of the clinical hold, would 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 77 - 
 
introduce bias into the assessment of the efficacy of the study treatment.  Therefore, all 
patients enrolled in stage 2 prior to the clinical hold will be excluded from efficacy 
analyses and will be replaced.  All treated patients will be included in all safety analyses. 
(5/23/2011) (06/27/2016) 
 
11.3.1 The anticipated period of active accrual for the 6 patients in the safety lead-in is 
approximately 4 months. 
 
11.3.2 The anticipated period of active accrual for the first stage (with a target of 21 patients 
plus 6 patients from the safety lead-in) is approximately 15 months. (5/23/2011) 
 
Thirty-seven patients were originally planned for Stage 2. As described above in Section 
11.3, all stage 2 patients accrued prior to the clinical hold (October 1, 2015) will be 
replaced. Therefore, a two-stage total of 90 patients will be targeted (including 29 
enrolled in the first stage [26 treated], 25 in Stage 2 [all to be replaced], and 37 to be 
accrued in order to complete stage 2, and thus have 63 evaluable patients.  Once 
accrual reopens, we expect accrual of 37 patients to complete in approximately twelve 
months (based on an accrual rate of about 3 patients per month for the year prior to the 
clinical hold going into effect). (06/27/2016) 
 
11.4 
The study plan is a single arm, 2-stage phase II clinical trial.  The study also includes a 
safety lead-in, in which the dose limiting toxicities of the study agent will be assessed in 
the first 6 patients enrolled. 
 
Safety Lead-in 
In Phase I trials, five patients have been treated with ADXS11-001 at the dose used in this 
study (1x109 cfu). No DLT has occurred in these patients or in the 5 patients at lower doses.  
We will examine in detail the DLT data for the first 6 patients in this study before enrolling 
the rest of the study’s patients. 
 
We denote by θ the probability of a DLT at the 1x109 cfu dose.  In the traditional 3+3 
phase I design used in the dose escalation phase, the implicit (but not technically correct) 
goal of the MTD estimation process is to obtain a dose that has a probability of a DLT 
less than 0.33.  We focus our consideration on the probability that θ [i.e., Pr(DLT) at the 
1x109 cfu dose], is higher than a target of 0.33. 
As proposed by Gönen71, we utilize a Bayesian interpretation of θ, in which θ is 
considered to be a random variable with a probability distribution.  We combine the data 
observed in our trial with a prior probability distribution for θ to obtain a posterior 
distribution for θ.  The DLT data is binomially distributed (DLT yes/no).  The conjugate 
prior for the binomial distribution is the beta distribution, so we assume the prior for θ, 
p(θ), to be Beta(α, β).  We denote the number of DLT-evaluable patients treated at the 
1x109 cfu in the dose safety lead-in to be NS, and of these we denote the number with 
DLTs to be XS.  The posterior for θ at the end of the safety lead-in is thus p(θ|X1), is thus 
Beta(α+XS, β+ NS − XS). (10/22/2012) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 78 - 
 
We specify a prior for θ that considers the information we have from the Phase I trial 
(0 DLTs out of 5 patients treated).  We use a Beta(α, β) with α=2 and β=6, which is the 
prior curve in Figure 11.1.  This reflects the belief that the pr(DLT) for the 1x109 cfu 
dose is most likely around 0.1 to 0.2. 
Figure 11.1 also shows the posterior distributions for θ given all various possible DLT 
results we may see in the safety lead-in of six patients. Under the different posterior 
distributions for θ, we can calculate the probability that θ exceeds a target of 0.33 given 
the data we have observed.  These are shown in Table 11.3.  For example, if we observe 
0/6 patients with DLTs safety lead-in, there is 0.04 probability that θ exceeds a target of 
0.33; whereas, if we see 3/6 patients with DLTs in the expanded cohort, there is a 0.56 
probability that θ exceeds a target of 0.33. 
Given these probabilities at the end of the safety lead-in, we can make informed decisions 
regarding the appropriateness of the choice of the phase II dose.  We can also use similar 
calculations to determine the probability that our MTD is too high after partial enrollment 
of the expanded cohort is enrolled, e.g., if the first three patients in the expanded cohort 
all have DLTs, the probability that θ exceeds our target of 0.33 is 0.57. 
Figure 11.1: Prior and Posterior Distributions for θ, the Pr (DLT) at 1x109 cfu dose 
 
 
Table 11.1: Prior and Posterior Probabilities that θ [Pr(DLT)] Exceeds a Target of 0.33 
 
Probability that θ Exceeds a 
Target of 0.33 
Prior (prior to Safety Lead-In) 
 
0.27 
Posterior (at End of Safety Lead-In) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 79 - 
 
Xs 
 
0 
0.04 
1 
0.14 
2 
0.33 
3 
0.56 
4 
0.77 
5 
0.90 
6 
0.97 
 
Phase II End point and design selection 
Survival at 12 months is the primary endpoint of the study for the reasons described 
above in section 2.6. 
 
The guiding principle in selecting the design for this study is to limit the number of 
patients treated with clinically ineffective therapies; yet to estimate efficacy with 
reasonable precision for those agents that are clinically active.  However, the accrual is 
complicated by the logistics of managing a multi-center phase II study. When the targeted 
sample size is attained, those patients who have already been approached will be 
permitted to register.  Strict adherence to a two-stage sampling design with ‘optimal’ 
early stopping rules is not practical.  Instead, flexible stopping rules are used that tend to 
maximize the probability of rejecting the treatment when the agent is indeed not active. 
 
Historical Data and Design Parameters 
The design parameters for this study arise from considering the results from the GOG 
0127 and 0227 study queues.  The patients enrolled into those studies are expected to 
behave similarly to those eligible for this study.  The purpose of those studies was to 
evaluate cytotoxic and cytostatic salvage regimens.  Those studies also implemented two-
stage stopping guidelines.  While clinical response is the primary endpoint in those 
studies, the survival times are also available.  The conclusions from those studies are that 
the agents studied had at most modest activity, except for protocol 0227-C, in which the 
agent was deemed active, is excluded.  All of the other sections concluded that the agent 
had limited activity, insignificant activity, or the like.  The estimated probability of 
surviving for at least 12 months is summarized in Table 11.2. 
 
We utilize a method proposed by Korn et al73 in which a logistic regression model was 
built based on past studies (shown in Table 11.2) to predict the probability of a patient 
surviving at least 12 months.  The following terms were examined to determine if they 
were significantly related to 12-month survival:  
• 
age (linear and quadratic terms) 
• 
cell type (squamous vs. other [unspecified adenocarcinoma, mucinous 
adenocarcinoma, adenosquamous]) 
• 
performance status (0 vs. 1 vs. 2 or 3) 
• 
number of prior chemotherapy regimens (0 or 1 vs. 2) 
• 
prior radiotherapy 
• 
extra-pelvic disease 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 80 - 
 
• 
grade 
• 
race (black, white, other) 
• 
stage. 
A backward elimination procedure was used, with p≤0.20 required for terms to remain in 
the model.  This resulted in the selection of age, age2, performance status, and race for the 
predictive model.  The same variables were selected when stepwise selection was used, 
with p<0.20 required for entry and to remain in the model.  Models were also built 
excluding variables (stage, grade, number of prior chemotherapy regimens, and extra-
pelvic disease) for which some patients had missing values; variable selected based on 
these models also matched the above. (10/22/2012) 
 
Between-trial variability was assessed using two methods.  First, as proposed by Korn et 
al72, we compared the proportion of patients surviving at 12 months in each protocol (ri 
based on ni patients in protocol i, i=1, …, k; k=17 protocols) with the overall proportion 
surviving at 12 months (r based on n patients).  If ri was outside the following interval, it 
was considered different from the overall event rate: 
1 0.025/
(1
)
i
k
i
n
n
r
z
r
r
n n





 
None of the trials had rates that differed significantly from the overall event rate. 
 
The second method to assess between-trial variability was to build a proportional hazards 
model with protocol section, and then to add the variables that were predictive to 
determine if they removed the significance of protocol section.  With the first model, 
protocol section had a statistically significant effect: p=0.0764 (based on 16 degrees of 
freedom).  When age, age2, performance status, and race were included in the model, 
protocol section was no longer significant: p=0.7662. (10/22/2012) 
 
The predictive model is shown in Table 11.3.  We will use this model to compute the 
expected (null) proportion of patients surviving 12 months in this planned trial.  We will 
then compare the actual proportion of patients surviving 12 months with the null value 
using the score chi-square test.  The model’s predicted probabilities of survival are 
presented graphically by race, performance status, and age in Figure 11.2. 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 81 - 
 
Table 11.2: Protocols 0127 and 0227: Probability of Surviving 12 Months by Study Section 
Protocol 
N of Evaluable 
Patients 
Proportion Surviving at 
Least 12 Months (SE)† 
0127-B 
34 
0.18 (0.07) 
0127-C 
44 
0.22 (0.06) 
0127-D 
29 
0.14 (0.06) 
0127-F 
40 
0.22 (0.07) 
0127-H 
24 
0.17 (0.08) 
0127-K 
25 
0.16 (0.07) 
0127-L 
44 
0.18 (0.06) 
0127-M 
25 
0.00 (0.00) 
0127-N-1 
32 
0.28 (0.08) 
0127-N-2 
32 
0.22 (0.07) 
0127-P 
23 
0.30 (0.10) 
0127-Q 
32 
0.28 (0.08) 
0127-R 
27 
0.30 (0.09) 
0127-S 
23 
0.22 (0.09) 
0127-T 
25 
0.28 (0.09) 
0127-U 
25 
0.24 (0.09) 
0227-D 
25 
0.16 (0.07) 
All 
509 
0.21 (0.02) 
† 
Product limit estimate of the probability of 
surviving at least 12 months, standard error in 
parentheses. 
 
Table 11.3: Predictive Logistic Regression Model for Survival at 12 Months 
Parameter 
Estimate 
Standard 
Error 
Wald 
Chi-Square 
Pr > ChiSq 
Intercept 
-4.2306 
1.8878 
5.0222 
0.0250 
age 
0.136 
0.0741 
3.3687 
0.0664 
age*age 
-0.00112 
0.000711 
2.4713 
0.1159 
Performance Status=0 
0.0 
NA 
NA 
NA 
Performance Status=1 
-0.6552 
0.2324 
7.9486 
0.0048 
Performance Status=2,3 
-3.5418 
1.0197 
12.0645 
0.0005 
Race=Black 
0.0 
NA 
NA 
NA 
Race=Other 
-0.688 
0.525 
1.7171 
0.1901 
Race=White 
-0.5172 
0.2882 
3.2192 
0.0728 
p < 0.0001 for Performance Status (with 2 df) 
p = 0.1674 for Race (with 2 df)] 
NA: not applicable. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 82 - 
 
Figure 11.2: Predicted Survival at 12 Months by Age, Race, and Performance Status 
 
For sample size calculation, we assume the expected null proportion of patients surviving 
12 months (denoted by ) to be the overall percentage across all trials (of inactive agents) 
in the 127 and 227 queues: 21% ≈ 20%.  We size the study to have 90% power to detect a 
15% increase in 12-month survival (to 35%) at a one-sided significance level of 0.10.  
We utilize a two-stage design, and we use the optimal sample size as proposed by 
Simon73 to set the targeted sample size for each stage: n1=27 (including 6 patients from 
safety lead-in), and n2=36 (n=63).  However, the actual method of Simon is not 
applicable here because of the dynamic nature of the null proportion of patients surviving 
12 months (i.e., the null value for the proportion of patients surviving 12 months depends 
on the observed patient characteristics).  The design is inherently flexible in that while we 
target these sample sizes, the actual attained sample sizes will be utilized in the analyses 
of stage 1 and overall. (5/23/2011) (10/22/2012) 
 
A conditional power approach will be utilized to determine if the second stage of accrual 
should be undertaken.  Conditional on the results from the first stage, the power to detect 
a statistically significant result at the end of the trial (after stage 2) will be calculated.  For 
this calculation, the 12-month survival probability in the second stage (p2) will be based 
on the estimated probability from the first stage (
): 
 
This “simple optimistic but plausible alternative” was proposed by Pepe and Anderson74  
and is shown to yield reasonable operating characteristics below. (10/22/2012) 
 
PS=0, Black
PS=0, Other
PS=0, White
PS=1, Black
PS=1, Other
PS=1, White
PS=2, Black
PS=2, Other
PS=2, White
Predicted Probability of Surviving at 12 Months
0.0
0.1
0.2
0.3
0.4
0.5
Age (y)
40
50
60
70
80

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 83 - 
 
If the conditional power at the end of stage 1 is <20%, then the trial will be stopped, 
otherwise, if clinical judgment indicates, the trial will continue to the second stage. 
 
 
Table 11.4 11.4 displays the operating characteristics of the trial.  These are based on 
10,000 simulated trials resampled from data of the trials listed in Table 11. 11.2.  The 
type I error control is maintained at <0.10, and power is maintained at 90%.  Under the 
null, the trial has 49.5% chance of stopping at the end of the first stage. 
 
If the result of the first stage becomes ineluctable with respect to the decision to open to a 
second stage, the second stage may be initiated sooner. 
 
Table 11.4: Operating Characteristics of Trial (5/23/2011) 
 
PET 
Probability of 
Rejecting H0 at end 
of study 
Under null (p≈0.20) 
0.495 
 
α = 0.075 
Under alternative (p≈0.35) 
0.058 
 1–β = 0.900 
PET = probability of early termination, i.e., at end of stage 1 
Based on 10,000 simulations of data resampled from the studies 
in listed Table 11. 11.2. 
Trial is stopped early if conditional power is <20% at the end of 
stage 1. 
n1=27 (including 6 patients from safety lead-in), n2=36, n=63. 
 
11.5 
Evaluability for efficacy and toxicity 
Only those patients who are deemed "ineligible" or who receive no therapy will be 
eliminated from the analysis.  All patients who receive any therapy will be evaluated for 
both treatment efficacy and toxicity.  While on occasion circumstances may prevent the 
determination of treatment efficacy, such patients will be included in the analysis and 
labeled as "indeterminate".  This category will be listed and reflected in the calculation of 
the response rate. 
 
11.6 
Data Safety and Monitoring 
Data sheets from patients on this protocol will be reviewed before each semi-annual 
meeting and will be reviewed by the Study Chairperson in conjunction with the Statistical 
and Data Center.  In some instances, because of unexpectedly severe toxicity, the 
Statistical and Data Center may elect, after consultation with the Study Chairperson and 
the Medical Oncology Committee, to recommend early closure of a study. 
 
The frequency and severity of all toxicities will be tabulated from submitted case report 
forms and summarized for review by the study chairperson, the Developmental 
Therapeutics Committee, and the GOG Safety Review Committee in conjunction with 
each semi-annual GOG meeting. For studies sponsored by the Cancer Therapy 
Evaluation Program (CTEP) of the National Cancer Institute (NCI), standardized toxicity 
reports are also submitted to the drug and disease monitors at the Investigational Drug 
Branch (IDB) and Clinical Investigation Branch (CIB).  The initial overall review of 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 84 - 
 
toxicity is usually performed after completion of the first stage of accrual, at which point 
accrual is generally suspended pending formal analysis of response and toxicity. 
 
All serious and/or unexpected events are communicated to the Study Chair, sponsor, and 
regulatory agencies as mandated in the protocol. These reports are reviewed by the Study 
Chair (or designated co-chair) within two working days for consideration of investigator 
notification, amendment, or immediate study suspension.  Additionally, all SAEs of 
sepsis, hypotension, or meningitis will be reviewed by the GOG Phase I Committee 
Chair and by the GOG Safety Review Committee Chair within 24 hours for 
consideration of investigator notification, amendment, or immediate study 
suspension.  All participating institutions will then receive notification of the toxicities 
and reason for study suspension.   Under these circumstances, accrual cannot be re-
activated until the study is reviewed by the GOG Safety Review Committee (SRC). 
However, patients currently receiving treatment may continue to receive treatment in 
accordance protocol guidelines at the discretion of their physicians, unless directed 
otherwise. (02/06/2012) 
 
In addition to the safety run-in of six patients to assess safety and in addition to the 
routine monitoring of safety described above this section, an additional assessment of 
safety and tolerability will done at the end of the first stage of accrual.  At that point, we 
will examine the numbers of patients with DLTs; if this number of patients exceeds the 
numbers in the Table 11.5 below (allowing for a range of possible accrual values), 
consideration will be given to stopping the trial due to excessive toxicity; discussion will 
occur between the study chair, study statistician, and the chair of the Developmental 
Therapeutics Committee. 
 
Table 11.5: Cutpoints for DLTs at the End of Stage 1 
n 
c 
Pr(X > c) 
given 
Prob(DLT )= 0.2 
Pr(X > c) 
given 
Prob(DLT )= 0.4 
24 
8 
.036 
.672 
25 
8 
.047 
.726 
26 
9 
.023 
.775 
27 
9 
.030 
.691 
28 
9 
.039 
.741 
29 
9 
.049 
.785 
30 
10 
.026 
.709 
n = 1st stage accrual 
c = cutpoint for number of DLTs 
X = observed number of patients with DLTs 
 
11.7 
Secondary and Exploratory Analyses 
Overall survival and progression-free survival will be characterized with Kaplan-Meier 
plots and estimates of the median time until death or progression. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 85 - 
 
Changes in serum cytokines will be examined with descriptive statistics and graphics, 
and their relationship with survival and tumor response will be examined with 
proportional hazards and logistic regression models, as appropriate. 
 
11.8 
Anticipated Gender and Minority Inclusion (5/23/2011) 
This study restricts entry to women by nature of the site of the disease.  The table below 
shows the projected numbers of patients by racial/ethnic subgroup (based on GOG 
protocol series 0127 and 0227) assuming 63 total patients are accrued. There are no data 
that support differences in the intervention effects between racial/ethnic subgroups; 
therefore, the study design does not involve race. However, subsets defined by white and 
non-white will be analyzed in this study to investigate this important question with the 
current therapies. The trial is registered at clinicaltrials.gov, and all patients who meet 
eligibility criteria are invited to participate.  
Ethnic Category 
Sex/Gender 
Females 
 
Males 
 
Total 
Hispanic or Latino 
 
5 
+ 0 
= 5 
Not Hispanic or Latino 
58 
+ 0 
= 58 
Ethnic Category: Total of all subjects 
63(A1) 
+ 0 
(B1) = 63 
(C1) 
Racial Category 
 
American Indian or Alaskan Native 
 
1 
+ 0 
=  
1 
Asian 
 
2 
+ 0 
=  
2 
Black or African American 
 
10 
+ 0 
=  
10 
Native Hawaiian or other Pacific Islander 
 
1 
+ 0 
=  
1 
White 
 
49 
+ 0 
=  
49 
Racial Category: Total of all subjects 
 
63 
(A2) 
+ 0 
(B2) =  
63 
(C2) 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 86 - 
 
12.0 
BIBLIOGRAPHY 
 
1. 
Ferlay, J., et al., Cancer incidence and mortality worldwide: sources, methods and major 
patterns in GLOBOCAN 2012. Int J Cancer, 2015. 136(5): p. E359-86. 
2. 
WHO/ICO Information Centre on HPV and Cervical Cancer, S.R.U., Human 
Papillomavirus and Related Cancers. Summary Report Update. 
3. 
SEER, National Cancer Institute SEER Stat Fact Sheets: Cervix Uteri. 
http://seer.cancer.gov/statfacts/html/cervix.html, 2013. 
4. 
Schiffman, M., et al., Human papillomavirus testing in the prevention of cervical cancer. 
J Natl Cancer Inst, 2011. 103(5): p. 368-83. 
5. 
Wheeler, C.M., et al., Human papillomavirus genotype distributions: implications for 
vaccination and cancer screening in the United States. J Natl Cancer Inst, 2009. 101(7): 
p. 475-87. 
6. 
Waggoner, S.E., Cervical cancer. The Lancet, 2003. 361(9376): p. 2217-2225. 
7. 
NCCN Guidelines: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. 
2015(Version 2). 
8. 
Monk, B.J., et al., Phase III trial of four cisplatin-containing doublet combinations in 
stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group 
study. J Clin Oncol, 2009. 27(28): p. 4649-55. 
9. 
Koberle, B., et al., Cisplatin resistance: preclinical findings and clinical implications. 
Biochim Biophys Acta, 2010. 1806(2): p. 172-82. 
10. 
Moore DH, Blessing JA, McQuellon RP, et al: Phase III study of cisplatin with or 
without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the 
cervix: A Gynecologic Oncology Group study. J Clin Oncol 22:3113-3119, 2004 
11. 
Long HJ, 3rd, Bundy BN, Grendys EC, Jr, et al. Randomized phase III trial of cisplatin 
with or without topotecan in carcinoma of the uterine cervix: A Gynecologic Oncology 
Group Study. J Clin Oncol. 2005;23:4626–4633. 
12. 
Tewari, K.S., et al., Improved survival with bevacizumab in advanced cervical cancer. N 
Engl J Med, 2014. 370(8): p. 734-43. 
13. 
Feltkamp, M.C., et al., Vaccination with cytotoxic T lymphocyte epitope-containing 
peptide protects against a tumor induced by human papillomavirus type 16-transformed 
cells. Eur J Immunol, 1993. 23(9): p. 2242-9. 
14. 
Feltkamp MC, Vrengdenhil GR, Vierboom MP, et al.  Expression, purification and 
immunological characterization of the transforming protein E7, from cervical cancer-
assiciated human papilloma-virus type 16.  Clin Exp Immunol.  1995; 115:397-403 
15. 
van Driel, W.J., et al., Vaccination with HPV16 peptides of patients with advanced 
cervical carcinoma: clinical evaluation of a phase I-II trial. Eur J Cancer, 1999. 35(6): p. 
946-52. 
16. 
Khleif SN, B.J., Berastein S, Contoise D, Wojtowicz M.  , A phase II HPV16 E6 and E7 
peptides vaccination in patients with advanced cervical cancer. . 18th International 
Papillomavirus Conference, Barcelona, Spain, Program and Abstracts Book. Abstract 
380., 2000. 
17. 
Fernando, G.J., et al., Expression, purification and immunological characterization of the 
transforming protein E7, from cervical cancer-associated human papillomavirus type 16. 
Clin Exp Immunol, 1999. 115(3): p. 397-403. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 87 - 
 
18. 
Giannoili C, G.F., Burny A, Leo O, Hallez S.  , HPV16 E7-based protein immunization 
induces long-term protective and therapeutic anti-tumor immunity in C57BL/6 mice. 
Program and Abstracts Book. 18th International Papillomavirus Conference, Barcelona, 
Spain, Abstract 429, 2000. 
19. 
Goldstone SE, T.J., Neefe JR. , Clinical and pathological response in a Phase II trial 
(SGN-00101-9902) of HspE7 in high grade anal dysplasia. . 18th International 
Papillomavirus Conference, Barcelona, Spain, Program and Abstracts Book. Abstract 
347a., 2000. 
20. 
Kadish AS, H.G., Wang Y, et al. , Single dose subcutaneous administration of HspE7 
induced lymphoproliferative responses to HPV16 E7 in healthy volunteers. . 18th 
International Papillomavirus Conference, Barcelona, Spain, Program and Abstracts Book. 
Abstract 365, 2000. 
21. 
Lacey, C.J., et al., Phase IIa safety and immunogenicity of a therapeutic vaccine, TA-GW, 
in persons with genital warts. J Infect Dis, 1999. 179(3): p. 612-8. 
22. 
Thompson, H.S., et al., Phase I safety and antigenicity of TA-GW: a recombinant HPV6 
L2E7 vaccine for the treatment of genital warts. Vaccine, 1999. 17(1): p. 40-9. 
23. 
Borysiewicz, L.K., et al., A recombinant vaccinia virus encoding human papillomavirus 
types 16 and 18, E6 and E7 proteins as immunotherapy for cervical cancer. Lancet, 
1996. 347(9014): p. 1523-7. 
24. 
Toes, R.E., et al., Protective anti-tumor immunity induced by vaccination with 
recombinant adenoviruses encoding multiple tumor-associated cytotoxic T lymphocyte 
epitopes in a string-of-beads fashion. Proc Natl Acad Sci U S A, 1997. 94(26): p. 14660-
5. 
25. 
Pan, Z.K., et al., A recombinant Listeria monocytogenes vaccine expressing a model 
tumour antigen protects mice against lethal tumour cell challenge and causes regression 
of established tumours. Nat Med, 1995. 1(5): p. 471-7. 
26. 
Frankel, F.R., et al., Induction of cell-mediated immune responses to human 
immunodeficiency virus type 1 Gag protein by using Listeria monocytogenes as a live 
vaccine vector. J Immunol, 1995. 155(10): p. 4775-82. 
27. 
Einstein, M.H., et al., Heat shock fusion protein-based immunotherapy for treatment of 
cervical intraepithelial neoplasia III. Gynecol Oncol, 2007. 106(3): p. 453-60. 
28. 
Nventa Biopharmaceuticals Corporation (formerly Stressgen).  Warts with HPV’s other 
than type 16 respond to HspE7 treatment [unpublished, internal document]. San Diego, 
CA. 
29. 
Davidson, E.J., et al., Immunological and clinical responses in women with vulval 
intraepithelial neoplasia vaccinated with a vaccinia virus encoding human 
papillomavirus 16/18 oncoproteins. Cancer Res, 2003. 63(18): p. 6032-41. 
30. 
Luxton, J.C., et al., Proliferative T cell responses to the human papillomavirus type 16 E7 
protein in women with cervical dysplasia and cervical carcinoma and in healthy 
individuals. J Gen Virol, 1996. 77 ( Pt 7): p. 1585-93. 
31. 
Selvey, L.A., et al., Identification of B-epitopes in the human papillomavirus 18 E7 open 
reading frame protein. J Immunol, 1990. 145(9): p. 3105-10. 
32. 
Krchnak, V., et al., Synthetic peptides derived from E7 region of human papillomavirus 
type 16 used as antigens in ELISA. J Gen Virol, 1990. 71 ( Pt 11): p. 2719-24. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 88 - 
 
33. 
McCarthy, C., S.J. Youde, and S. Man, Definition of an HPV18/45 cross-reactive human 
T-cell epitope after DNA immunisation of HLA-A2/KB transgenic mice. Int J Cancer, 
2006. 118(10): p. 2514-21. 
34. 
Nilges, K., et al., Human Papillomavirus Type 16 E7 Peptide-Directed CD8+ T Cells 
from Patients with Cervical Cancer Are Cross-Reactive with the Coronavirus NS2 
Protein. J Virol, 2003. 77(9): p. 5464-5474. 
35. 
Pan, Z.K., et al., Regression of established tumors in mice mediated by the oral 
administration of a recombinant Listeria monocytogenes vaccine. Cancer Res, 1995. 
55(21): p. 4776-9. 
36. 
Wallecha, A., et al., Multiple effector mechanisms induced by recombinant Listeria 
monocytogenes anticancer immunotherapeutics. Adv Appl Microbiol, 2009. 66: p. 1-27. 
37. 
Hussain, S.F. and Y. Paterson, CD4+CD25+ regulatory T cells that secrete TGFbeta and 
IL-10 are preferentially induced by a vaccine vector. J Immunother, 2004. 27(5): p. 339-
46. 
38. 
Shahabi, V., et al., Development of a Listeria monocytogenes based vaccine against 
prostate cancer. Cancer Immunol Immunother, 2008. 57(9): p. 1301-13. 
39. 
Tindle, R.W., Human papillomavirus vaccines for cervical cancer. Curr Opin Immunol, 
1996. 8(5): p. 643-50. 
40. 
Slifka, M.K., The Future of Smallpox Vaccination: is MVA the key? Med Immunol, 2005. 
4(1): p. 2. 
41. 
Raper, S.E., et al., Fatal systemic inflammatory response syndrome in a ornithine 
transcarbamylase deficient patient following adenoviral gene transfer. Mol Genet Metab, 
2003. 80(1-2): p. 148-58. 
42. 
Paterson, Y. and R.S. Johnson, Progress towards the use of Listeria monocytogenes as a 
live bacterial vaccine vector for the delivery of HIV antigens. Expert Rev Vaccines, 2004. 
3(4 Suppl): p. S119-34. 
43. 
Jacobson, N.G., et al., Regulation of interleukin-12 signalling during T helper phenotype 
development. Adv Exp Med Biol, 1996. 409: p. 61-73. 
44. 
Gunn, G.R., et al., Two Listeria monocytogenes vaccine vectors that express different 
molecular forms of human papilloma virus-16 (HPV-16) E7 induce qualitatively different 
T cell immunity that correlates with their ability to induce regression of established 
tumors immortalized by HPV-16. J Immunol, 2001. 167(11): p. 6471-9. 
45. 
Cheers, C., et al., Resistance and susceptibility of mice to bacterial infection: course of 
listeriosis in resistant or susceptible mice. Infect Immun, 1978. 19(3): p. 763-70. 
46. 
Quesada, A., Acute Dose Toxicity of Lm-LLO-E7 in Babl/C Mice. GLP Study # 8920-05. 
Stillmeadow, Inc. Sugar Land, TX. 2005. 
47. 
Quesada, A., Four week study of Lm-LLO-E7 vector Mice. GLP Study # 898505. 
Stillmeadow, Inc. Sugar Land, TX. 2005. 
48. 
Quesada, A., Acute Intravenous Toxicity Study of Lm-LLO-E7 in Female SCID Mice. 
GLP Study # 9190-05. Stillmeadow Inc. Sugar Land, TX. 2005. 
49. 
Quesada, A., Biodistribution Study of Lm-LLO-E7 in Female Mice. GLP Study # 8986-
05. Stillmeadow Inc. Sugar Land, TX. 2005. 
50. 
Quesada, A., Acute Intravenous Clearance Study of Lm-LLO-E7 in Female Mice. GLP 
Study # 9189-05. Stillmeadow Inc. Sugar Land, TX. 2005. 
51. 
Quesada, A., Clearance Study of Intravenous Administration of LmLLO-E7 in Female 
Balb/C Mice. GLP Study # 9355-05. Stillmeadow Inc. Sugar Land, TX. 2005. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 89 - 
 
52. 
Schafer, R., et al., Induction of a cellular immune response to a foreign antigen by a 
recombinant Listeria monocytogenes vaccine. J Immunol, 1992. 149(1): p. 53-9. 
53. 
Maciag, P.C., S. Radulovic, and J. Rothman, The first clinical use of a live-attenuated 
Listeria monocytogenes vaccine: a Phase I safety study of Lm-LLO-E7 in patients with 
advanced carcinoma of the cervix. Vaccine, 2009. 27(30): p. 3975-83. 
54. 
Beebe, J.L. and E.W. Koneman, Recovery of uncommon bacteria from blood: association 
with neoplastic disease. Clin Microbiol Rev, 1995. 8(3): p. 336-56. 
55. 
Le Monnier, A., et al., Listeria monocytogenes: a rare complication of 
ventriculoperitoneal shunt in children. J Clin Microbiol, 2011. 49(11): p. 3924-7. 
56. 
Dominguez, E.A., A.A. Patil, and W.M. Johnson, Ventriculoperitoneal shunt infection 
due to Listeria monocytogenes. Clin Infect Dis, 1994. 19(1): p. 223-4. 
57. 
Winslow, D.L. and M.L. Steele, Listeria bacteremia and peritonitis associated with a 
peritoneovenous shunt: successful treatment with sulfamethoxazole and trimethoprim. J 
Infect Dis, 1984. 149(5): p. 820. 
58. 
Charlier, C., et al., Listeria monocytogenes-associated joint and bone infections: a study 
of 43 consecutive cases. Clin Infect Dis, 2012. 54(2): p. 240-8. 
59. 
Hoos, A., et al., A clinical development paradigm for cancer vaccines and related 
biologics. J Immunother, 2007. 30(1): p. 1-15. 
60. 
Schlom, J., P.M. Arlen, and J.L. Gulley, Cancer vaccines: moving beyond current 
paradigms. Clin Cancer Res, 2007. 13(13): p. 3776-82. 
61. 
Schlom, J., J.L. Gulley, and P.M. Arlen, Paradigm shifts in cancer vaccine therapy. Exp 
Biol Med (Maywood), 2008. 233(5): p. 522-34. 
62. 
Chosewood LC, W.D., editors, Biosafety in microbiological and biomedical laboratories 
(BMBL) 5th ed. US Department of Health and Human Services. 
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm, 2009. 
63. 
Lorber, B., Listeria monocytogenes, in PRINCIPLES AND PRACTICE OF INFECTIOUS 
DISEASES, B. Mandell, and Dolan, Editor. 2000. p. 2208-14  
64. 
Maciag, P.C., S. Radulovic, and J. Rothman, The first clinical use of a live-attenuated 
Listeria monocytogenes vaccine: a Phase I safety study of Lm-LLO-E7 in patients with 
advanced carcinoma of the cervix. Vaccine, 2009. 27(30): p. 3975-83 
65. 
Grupp, S.A., et al., Chimeric antigen receptor-modified T cells for acute lymphoid 
leukemia. N Engl J Med, 2013. 368(16): p. 1509-18. 
66. 
Lee, D.W., et al., Current concepts in the diagnosis and management of cytokine release 
syndrome. Blood, 2014. 124(2): p. 188-95. 
67. 
Winkler, U., et al., Cytokine-release syndrome in patients with B-cell chronic 
lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 
monoclonal antibody (rituximab, IDEC-C2B8). Blood, 1999. 94(7): p. 2217-24. 
68. 
Herceptin, Package Insert. Genentech, Inc., 2015. 
69. 
http://www.cdc.gov/listeria accessed September 23, 2015. 
70. 
Wolchok, J.D., et al., Guidelines for the evaluation of immune therapy activity in solid 
tumors: immune-related response criteria. Clin Cancer Res, 2009. 15(23): p. 7412-20. 
71. 
Gönen M, A Bayesian evaluation of enrolling additional patients at the maximum 
tolerated dose in phase I trials. Contemporary Clinical Trials, 2005. 26: p. 131-140. 
72. 
Korn, E.L., et al., Meta-analysis of phase II cooperative group trials in metastatic stage 
IV melanoma to determine progression-free and overall survival benchmarks for future 
phase II trials. J Clin Oncol, 2008. 26(4): p. 527-34. 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 90 - 
 
73. 
Simon, R., Optimal two-stage designs for phase II clinical trials. Control Clin Trials, 
1989. 10(1): p. 1-10. 
74. 
Pepe MS, A.G., Two-stage experimental designs: early stopping with a negative result. 
Applied Statistics., 1992. 41: p. 181-190. 
 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 91 - 
 
 
APPENDIX I – TRANSLATIONAL RESEARCH SPECIMEN PROCEDURES (05/06/2013) 
(06/27/2016) 
 
 
Summary of Specimen Requirements (10/17/2011) (10/22/2012) 
 
If the patient gives permission for her specimens to be collected and used for this optional 
translational research component, then participating institutions within the United States are 
required to submit the patient’s specimens as outlined below (unless otherwise specified). 
 
Required Specimen 
(Specimen Code) 
Collection Time Point 
Ship To 
FFPE Primary Tumor (FP01)* 
1st Choice: block 
2nd Choice: 15 unstained slides 
(charged, 5µm)  
Prior to all treatment 
Ship to the GOG Tissue Bank within 8 
weeks of registration1 
FFPE Metastatic Tumor (FM01)* 
1st Choice: block 
2nd Choice: 15 unstained slides 
(charged, 5µm)  
Optional if FP01or FR01 is submitted 
 
Prior to all treatment 
FFPE Recurrent Tumor (FR01)* 
1st Choice: block 
2nd Choice: 15 unstained slides 
(charged, 5µm)  
Optional if FP01or FM01 is submitted 
 
Prior to starting ADXS11-001 
Pre-Dose 1 Serum (SB01) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
Prior to dose 1 of ADXS11-001 
Ship to the GOG Tissue Bank within 2 
weeks of study entry1 
2 Hour Post-Dose 1 Serum (SB02) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
2 hours after dose 1 of ADXS11-001 
8 Hour Post-Dose 1 Serum (SB03) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
8 hours after dose 1 of ADXS11-001 
24 Hour Post-Dose 1 Serum (SB04) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
24 hours after dose 1 of ADXS11-001 
Pre-Dose 2 Serum (SB05) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
Prior to dose 2 of ADXS11-001 
Ship to the GOG Tissue Bank within 6 
weeks of study entry1 
2 Hour Post-Dose 2 Serum (SB06) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
2 hours after dose 2 of ADXS11-001 
8 Hour Post-Dose 2 Serum (SB07) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
8 hours after dose 2 of ADXS11-001 
24 House Post-Dose 2 Serum (SB08) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
24 hours after dose 2 of ADXS11-001 
Pre-Dose 3 Serum (SB09) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
Prior to dose 3 of ADXS11-001 
Ship to the GOG Tissue Bank within 10 
weeks of study entry1 
2 Hour Post-Dose 3 Serum (SB10) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
2 hours after dose 3 of ADXS11-001 
8 Hour Post-Dose 3 Serum (SB11) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
8 hours after dose 3 of ADXS11-001 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 92 - 
 
24 Hour Post-Dose 3 Serum (SB12) 
prepared from 7-10mL of blood drawn 
into a plain red top tube 
24 hours after dose 3 of ADXS11-001 
* A copy of the corresponding pathology report must be shipped with all tissue specimens sent to the GOG Tissue Bank 
(10/22/2012) 
1 
Ship specimens to: GOG Tissue Bank / Protocol GOG-0265, Nationwide Children’s Hospital, 700 Children’s Drive, 
WA1340, Columbus, OH 43205, Phone: 614-722-2865, Fax: 614-722-2897, Email: gogbank@nationwidechildrens.org 
(12/23/2013) 
 
Obtaining a GOG Bank ID for Translational Research Specimens (10/22/2012) 
 
Only one GOG Bank ID (# # # # - # # - G # # #) is assigned per patient. All translational research 
specimens and accompanying paperwork must be labeled with this coded patient number. A 
GOG Bank ID can be obtained online via the Tissue Bank Portal on the GOG website (under 
Tools on the Web Menu page).  
 
Obtain the GOG patient study ID for all GOG protocols with translational research specimen 
requirements before requesting a Bank ID from the Tissue Bank Portal. Be sure to indicate if 
the patient has a previous GOG # when registering. This will ensure that the patient is only 
assigned one Bank ID. The GOG ID – Bank ID Lookup on the Tissue Bank Portal can be used to 
search for an existing Bank ID. (02/06/2012) 
 
Please contact GOG User Support if you need assistance or have assigned more than one Bank 
ID to a patient (Email: support@gogstats.org; Phone: 716-845-7767). 
 
III. Requesting Specimen Kits 
 
One single-chamber specimen kit will be provided per patient for the collection and shipment of 
serum for each time point (Dose 1, Dose 2, and Dose 3). (12/23/2013) 
 
Translational research specimen kits can be ordered online via the Kit Management link on the 
GOG website (under Data Entry on the Web Menu page). Each site may order a maximum of 
two specimen kits per protocol per day (daily max = 6 kits). 
 
Please contact the GOG Tissue Bank if you need assistance (Email: 
GOGBank@nationwidechildrens.org; Phone: 866-GOG-BANC/866-464-2262). 
 
 
Be sure to plan ahead and allow time for kits to be shipped by ground transportation. 
 
Note: Unused materials and kits should be returned to the GOG Tissue Bank. 
 
IV.  
Labeling Translational Research Specimens 
 
A waterproof permanent marker or printed label should be used to label each translational 
research specimen with: 
 
GOG Bank ID (# # # # - # # - G # # #) 
GOG protocol number (GOG- # # # #) 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 93 - 
 
specimen code (see section I) 
collection date (mm/dd/yyyy) 
surgical pathology accession number (tissue specimens only) 
block number (tissue specimens only) 
 
Note: If labeling slides, only label on the top, front portion of the slide. Do not place a label on 
the back of the slide or over the tissue. The label must fit on the slide and should not be wrapped 
around the slide or hang over the edge. 
 
V. 
Submitting Archival Formalin-Fixed, Paraffin-Embedded Tumor (10/22/2012) 
(12/23/2013) 
 
Formalin-fixed, paraffin embedded (FFPE) tissue should be the most representative of the 
specimen type (primary, metastatic, recurrent). Primary and metastatic tumor should be collected 
prior to all treatment. Recurrent tumor should be collected prior to the study treatment. Only one 
block may be submitted per tissue type. 
 
Every attempt should be made to provide a tumor block; however, if a block cannot be provided 
on a permanent basis, then 15 unstained sections (charged, 5µm) should be submitted. All tissue 
sections should be cut sequentially from the same block. 
 
The type of specimen (block or slides) should be specified on Form SP. 
 
If submitting recurrent tumor, include a comment on Form SP noting whether the tumor is from 
the primary site or a metastatic site. 
 
All FFPE tissue should be submitted with the corresponding pathology report. 
 
VI. 
Submitting Serum Specimens 
 
1. Label cryovials and a 15mL conical tube as described above. Use 2mL cryovials if serum 
will be shipped to the GOG Tissue Bank. 
 
2. Draw 7-10mL of blood into red top tube(s).  
 
3. Allow the blood to clot at 4°C (or in a bucket with ice) for at least 30 minutes but no 
longer than 3 hours. 
 
4. Centrifuge the blood at 1000g for 15 minutes at 4ºC (preferred) or room temperature to 
separate the serum (top, straw-colored layer) from the red blood cells (bottom, red layer). 
 
5. Transfer the serum into a 15mL conical tube and gently mix. 
 
6. Quickly, evenly dispense (aliquot) the serum into the pre-labeled cryovials and cap 
the tubes securely. Place a minimum of 0.25mL into each cryovial. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 94 - 
 
7. Immediately freeze the serum in an upright position in a -70oC to -80oC freezer or by 
direct exposure with dry ice until ready to ship. If a -70oC to -80oC freezer is not 
available for storage, store and ship on dry ice within 24 hours of collection. 
  
VII. 
Submitting Form SP 
 
Form SP must be submitted via SEDES for each required specimen regardless of whether the 
specimen is submitted for research. 
 
A copy of the SEDES-completed Form SP must accompany each specimen shipped to the GOG 
Tissue Bank. Handwritten forms will not be accepted. 
 
Note: A copy does not need to be sent if the specimen is not collected. 
 
Retain a printout of the completed form for your records. 
 
Please contact GOG User Support if you need assistance (Email: support@gogstats.org; Phone: 
716-845-7767). 
  
VIII. Shipping Translational Research Specimens 
 
A SEDES-completed copy of Form SP must be included for each translational research 
specimen. 
 
A.  
FFPE Tissue 
 
FFPE tissue and a copy of the corresponding pathology report should be shipped using your own 
shipping container at your own expense to: 
 
GOG Tissue Bank / Protocol GOG-0265 
Nationwide Children’s Hospital  
700 Children’s Dr, WA1340 
Columbus, OH 43205 
Phone: 614-722-2865 
Fax: 614-722-2897 
E-mail: gogbank@nationwidechildrens.org 
 
Do not ship FFPE tissue for Saturday delivery. 
 
 
B. 
Frozen Serum 
 
Frozen serum should be shipped using the specimen kits provided to the GOG Tissue Bank 
(address above). 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 95 - 
 
Frozen specimens should be shipped Monday through Thursday for Tuesday through Friday 
delivery. Do not ship frozen specimens on Friday or the day before a holiday. Note: Saturday 
delivery is not available for frozen specimens.  
 
Frozen specimens should be stored in an ultra-cold freezing/storage space (i.e., ultra cold ≤-70oC 
freezer, liquid nitrogen, or direct exposure with dry ice) until the specimens can be shipped. 
 
Instructions for Shipping Frozen Specimens 
 
Pre-fill the kit chamber about 1/3 full with dry ice. 
 
Place the frozen specimens from each time point in a separate zip-lock bag. 
 
Place the zip-lock bags in the biohazard envelope containing absorbent material. Do not put more 
than 25 vials in the biohazard envelope. Put the secondary envelope into a Tyvek envelope. Expel 
as much air as possible before sealing both envelopes. 
 
Place the Tyvek envelope containing the frozen specimens into the kit and fill the chamber to the 
top with dry ice. 
 
Insert a copy of Form SP for each specimen.  
 
Place the cover on top of the kit. Tape the outer box of the kit closed with filament or other durable 
sealing tape. Please do not tape the inner chamber.  
 
Print a pre-paid FedEx air bill using the Kit Management application (found under Data Entry on 
the Web Menu page). Attach the air bill. 
 
Attach the dry ice label (UN1845) and the Exempt Human Specimen sticker. 
 
Arrange for FedEx pick-up through your usual Institutional procedure or by calling 800-238-
5355. 
 
IX. 
Distributing Translational Research Specimens 
 
The GOG Statistical and Data Center and the GOG Tissue Bank will coordinate the distribution 
of specimens to approved investigators. 
 
Investigators will not be given access to any personal identifiers. 
 
Investigators will be responsible for the direct supervision and oversight of translational research 
and for keeping accurate records. 
 
Investigators will ensure the results are linked to the appropriate specimen-specific identifiers 
and are responsible for transferring relevant laboratory data to the Statistical and Data Center. 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 96 - 
 
At the discretion of the Chair of the Committee on Experimental Medicine and the Director of 
the GOG Tissue Bank, investigators may be required to ship any specimens (or by-products) 
remaining after the completion of the translational research to the GOG Tissue Bank. 
 
A. FFPE (06/27/2016) 
 
 
Unstained sections of tumor will be batch shipped upon trial completion to Advaxis: 
 
Advaxis, Inc. 
ATTN: Dr. Jun Zou 
305 College Road East 
Princeton, NJ 08540 
Phone: 609-250-7502 
Fax: 609-452-9818 
Email: zou@advaxis.com 
 
B. Frozen Serum 
 
An aliquot of frozen serum will be batch shipped upon trail completion to Advaxis (address 
above). 
 
X. Banking Translational Research Specimens for Future Research 
 
Specimens will remain banked in the GOG Tissue Bank and made available for approved 
research projects if the patient has provided permission for the use of her specimens for future 
health research. The patient’s choices will be recorded on the signed informed consent document 
and electronically via the online Specimen Consent Application. At the time of specimen 
selection for project distribution, the most recent consent information will be used. 
 
GOG institutions can amend the patient’s choices regarding the future use of her 
specimens at any time if the patient changes her mind. 
 
If the patient revokes permission to use her specimens, the GOG Tissue Bank will destroy or 
return any remaining specimens. The patient’s specimens will not be used for any further 
research; however, any specimens distributed for research prior to revoking consent cannot be 
returned or destroyed. In addition, the patient cannot be removed from any research that has been 
done with her specimens distributed prior to revoking consent. 
 
Note: If return of specimens is requested, shipping will be at the institution’s expense. 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 97 - 
 
 
APPENDIX II-  PATIENT DRUG CALENDAR – NAPROXEN or IBUPROFEN 
 (12/23/2013) (06/27/2016) 
 
Visit Log is returned every four weeks 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
Date: _______________________________________Infusion #: __________________________________ 
 
 
This is a calendar to help you track when you have taken your naproxen or ibuprofen.  Each time 
you return to your doctor’s office for the next infusion, please bring this calendar with you and 
you will be provided with a new one.  When taking the Naproxen OR ibuprofen it should be 
taken within 30 minutes before the ADXS11-001 dose, 4 hours after the infusion is completed 
then you can take Naproxen OR ibuprofen as needed.  If you have any questions at any time 
please contact your study doctor’s office.  
 
 
Naproxen OR 
Ibuprofen 
AM Dose 
PM Dose 
 
 
 
Day of ADXS11-
001 Infusion 
Time _______ 
(220mg/400 mg) 
Time _______ 
(220mg/400mg) 
Record any additional doses of Naproxen or Ibuprofen 
taken below: 
Date 
Time 
Dose 
(220mg/400mg) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 98 - 
 
APPENDIX III - PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) REGULAR STRENGTH 
(12/23/2013) (06/27/2016) 
 
 (02/06/2012)  
 
Visit Log is returned every four weeks 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
Date: ____________________________________ 
Infusion #: __________________________________ 
 
 
This is a calendar to help you track when you have taken your trimethoprim/sulfamethoxazole. 
You will take trimethoprim/sulfamethaxazole for a 7 day course after receiving the ADXS11-001 
(Days 4-10).  Each time you return to your doctor’s office for the next infusion, please bring this 
calendar with you and you will be provided with a new one.  . When taking the regular strength 
trimethoprim (80mg)/ sulfamethoxazole (400 mg), it should be taken once daily during the 7 day 
course. If you have any questions at any time please contact your study doctor’s office.  
 
 
 
 
 
 
Date/Day of Week 
Time 
DAY 1 ADXS11-
001 Infusion 
Date: ______________ 
 
Day: ______________ 
 
Trimethoprim-sulfamethoxazole Regular Strength1 tablet for 7 days 
Day 4 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 5 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 6 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 7 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 8 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 9 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 10 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 99 - 
 
APPENDIX IV - PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) DOUBLE STRENGTH 
(DS) (06/27/2016) 
 
Visit Log is returned every four weeks 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
Date: ____________________________________ 
Infusion #: __________________________________ 
 
 
This is a calendar to help you track when you have taken your trimethoprim/sulfamethoxazole 
Double Strength (DS). You will take trimethoprim/sulfamethaxazole for a 3 days over 7 days 
after receiving the ADXS11-001 (Days 4-10).  Each time you return to your doctor’s office for 
the next infusion, please bring this calendar with you and you will be provided with a new one.  . 
When taking the double strength trimethoprim (160mg)/ sulfamethoxazole (800 mg), it should be 
taken once daily on days 4, 7 and 10. If you have any questions at any time please contact your 
study doctor’s office.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date/Day of Week 
 
 
 
Time 
DAY 1 ADXS11-
001 Infusion 
Date: ______________ 
 
Day: ______________ 
 
Trimethoprim-sulfamethoxazole Double Strength 1 tablet for 3 days 
Day 4 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 7 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
Day 10 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 100 - 
 
APPENDIX V - PATIENT DRUG CALENDAR – AMPICILLIN (06/27/2016) 
 
This calendar is to be used for patients who are not able to receive 
trimethoprim/sulfamethoxazole  
 
Visit Log is returned every four weeks 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
 
Date: ____________________________________ 
Infusion #: __________________________________ 
 
 
This is a calendar to help you track when you have taken your your ampicillin.  You will take 
ampicillin for 7 days after receiving the ADXS11-001.  Each time you return to your doctor’s 
office for the next infusion, please bring this calendar with you and you will be provided with a 
new one. When taking the ampicillin, it should be taken four times a day. If you have any 
questions at any time please contact your study doctor’s office.  
 
 
 
 
 
DATE/DAY of Week 
Time 
Time 
Time  
Time 
DAY 1 
ADXS11-001 
Infusion 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Ampicillim 500 mg 4 times a day for 7 days 
Day 4 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Day 5 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Day 6 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Day 7 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Day 8 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Day 9 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 
Day 10 (post-
infusion) 
Date: ______________ 
 
Day: ______________ 
 
 
 
 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 101 - 
 
APPENDIX VI – Post Study Treatment PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE  (BACTRIM) REGULAR STRENGTH 
(06/27/2016) 
Post Study Treatment (6 month course) 
 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
 
Date to begin 6-month antibiotic course: ___________________________________________ 
 
 
This is a calendar to help you track when you have taken your trimethoprim/sulfamethoxazole 
after you have completed your treatment with ADXS11-001. When taking the regular strength 
trimethoprim (80mg)/ sulfamethoxazole (400 mg), it should be taken once daily during the 6-
month course. If you have any questions at any time please contact your study doctor’s office 
Each time you return to your doctor’s office, please bring this calendar with you.   
 
Trimethoprim/Sulfamethoxazole Regular Strength Patient Pill Calendar for 6 month post‐treatment 
Prophylaxis 
Trimethoprim/ 
Sulfamethoxazole 
daily 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Sunday 
Week 1 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 2 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 3 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 4 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 5 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 6 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 102 - 
 
Week 7  
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 8 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 9 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 10 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 11 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 12 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 13 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 14 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 15 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 16 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 17 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 18 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 103 - 
 
 
 
 
 
Week 19 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 20 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 21 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 22 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 23 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 
Week 24 
Date:____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:____ 
Date:_____ 
Time:_____ 
Date:____ 
Time:____ 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 104 - 
 
APPENDIX VII -Post Study Treatment PATIENT DRUG CALENDAR –
TRIMETHOPRIM/SULFAMETHOXAZOLE (BACTRIM) DOUBLE STRENGTH 
(06/27/2016) 
 
Post Study Treatment (6 month course) 
 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
 
Date to begin 6-month antibiotic course: ___________________________________________ 
 
 
This is a calendar to help you track when you have taken your trimethoprim/sulfamethoxazole 
after you have completed your treatment with ADXS11-001. When taking the double strength 
trimethoprim (160mg)/ sulfamethoxazole (800 mg), it should be taken three times a week (every 
Monday, Wednesday and Friday) during the 6-month course. If you have any questions at any 
time please contact your study doctor’s office Each time you return to your doctor’s office, 
please bring this calendar with you.   
 
Trimethoprim/Sulfamethoxazole Patient Pill Calendar for 6 month post‐treatment Prophylaxis 
Trimethoprim/ 
Sulfamethoxazole 
3 times/ week 
Monday 
Wednesday 
Friday 
Week 1 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 2 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 3 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 4 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 5 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 6 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 105 - 
 
Week 7  
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 8 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 9 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 10 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 11 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 12 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 13 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 14 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 15 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 16 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 17 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 18 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 

NCI Protocol #: GOG-0265 
Version Date: 05/20/2016 
- 106 - 
 
Week 19 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 20 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 21 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 22 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 23 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
Week 24 
Date:_______________ 
Time:_______________ 
Date:_______________ 
Time:______________‐ 
Date:______________ 
Time:______________ 
 

 
 
- 107 - 
 
APPENDIX VIII – Post Study Treatment PATIENT DRUG CALENDAR –AMPICILLIN 
Post Study Treatment (6 month course) (06/27/2016) 
 
(Ampicillin is to be used only for patients who cannot take sulfamethaxozole/trimethoprim) 
 
Patient Name: ______________________________ Patient Study ID______________________________ 
 
Date to begin 6-month antibiotic course: ___________________________________________ 
 
This is a calendar to help you track when you have taken your ampicillin after you have 
completed your treatment with ADXS11-001.  Each time you return to your doctor’s office, 
please bring this calendar with you.  When taking the ampicillin, it should be taken four times a 
day every day for 6 months.  If you have any questions at any time please contact your study 
doctor’s office.  
 
Ampicillin 
4 doses 
per day 
Sunday 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Week 1 
 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 2 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 3 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 

 
 
 
- 108 - 
Time: __ 
Time: ___ 
Time: ____ 
Time: ____ 
Time: _____  Time: __ 
Time: __ 
Week 4 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
  
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 5 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 6 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 7  
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 8 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Date:___ 
 
Time:___ 
 
Time:___ 
 

 
 
 
- 109 - 
Time:___ 
 
Time: __ 
Time:____ 
 
Time: ___ 
Time:____ 
 
Time: ____ 
Time:_____ 
 
Time: _____ 
Time:_____ 
 
Time: _____ 
Time:___ 
 
Time: __ 
Time:___ 
 
Time: __ 
Week 9 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 10 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 11 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 12 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 13 
Date:___ 
 
Time:___ 
 
Date:____ 
 
Time:____ 
 
Date:_____ 
 
Time:____ 
 
Date:_____ 
 
Time:_____ 
 
Date:_____ 
 
Time:_____ 
 
Date:___ 
 
Time:___ 
 
Date:___ 
 
Time:___ 
 

 
 
 
- 110 - 
Time:___ 
 
Time:___ 
 
Time: __ 
Time:____ 
 
Time:____ 
 
Time: ___ 
Time:____ 
 
Time:____ 
 
Time: ____ 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Time:___ 
 
Time:___ 
 
Time: __ 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 14 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 15 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 16 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 17 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 18 
Date:___ 
 
Date:____ 
 
Date:_____ 
 
Date:_____ 
 
Date:_____ 
 
Date:___ 
 
Date:___ 
 

 
 
 
- 111 - 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 19 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 20 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 21 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 22 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 

 
 
 
- 112 - 
Week 23 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Week 24 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ___ 
Date:_____ 
 
Time:____ 
 
Time:____ 
 
Time:____ 
 
Time: ____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time:_____ 
 
Time: _____ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
Date:___ 
 
Time:___ 
 
Time:___ 
 
Time:___ 
 
Time: __ 
 
 
 

 
 
 
- 113 - 
APPENDIX IX - GOG GENERAL CHEMOTHERAPY GUIDELINES  (06/27/2016) 
 
 For 21 or 28 day cycles, a patient will be permitted to have a new cycle of chemotherapy 
delayed up to 7 days (without this being considered to be a protocol violation) for major 
life events (e.g., serious illness in a family member, major holiday, vacation which is 
unable to be re-scheduled).  Documentation to justify this decision should be provided. 
 It will be acceptable for individual chemotherapy doses to be delivered within a “24-hour 
window before and after the protocol-defined date” for “Day 1” treatment of 21 or 28 day 
cycles.  If the treatment due date is a Friday, and the patient cannot be treated on that 
Friday, then the window for treatment would include the Thursday (1 day earlier than 
due) through the Monday (day 3 past due). 
 For weekly regimens, it will be acceptable for individual chemotherapy doses to be 
delivered within a “24-hour window,” for example; “Day 8 chemotherapy” can be 
delivered on Day 7, Day 8, or Day 9 and “Day 15 chemotherapy” can be given on Day 
14, Day 15, or Day 16. 
 Chemotherapy doses can be “rounded” according to institutional standards without being 
considered a protocol violation (most institutions use a rule of approximately +/- 5% of 
the calculated dose). 
 Chemotherapy doses are required to be recalculated if the patient has a weight change of 
greater than or equal to 10%.  Patients are permitted to have chemotherapy doses 
recalculated for < 10% weight changes.