The Clinical Research E-News Volume 8: ISSUE 7: July 29, 2016

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1 The Clinical Research E-News Volume 8: ISSUE 7: July 29, 2016 The Thomas Jefferson Sidney Kimmel Cancer Network (SKCN) would like to welcome our newest cancer network members, Kennedy Health System and Phoenixville Hospital. Title: Utilizing Multiomic Advanced Diagnostics to Identify Palbociclib Response Predictors and a Post-treatment Multiomic Signature for Patients with ER+/HER2- Metastatic Breast Cancer (SO-BCA-003) PI: Maysa Abu-Khalaf, MD Objective: To evaluate baseline phosphorylated RB levels in tumor tissue as a predictive marker of response to palbociclib as first line treatment for ER-/HER2+ metastatic breast cancer. Inclusion Criteria: Patients must have histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease. Tumors must be estrogen and/or progesterone receptor positive according to ASCO/CAP 2010 guidelines as either ER or PR 1% positive nuclear staining by immunohistochemistry based on local laboratory results. Tumors must be HER2 negative as defined according to ASCO/CAP 2013, as HER by IHC or non-amplified FISH or CISH. If HER2 IHC is 2+, FISH/CISH must be performed and must not be positive (HER2/CEP17 ratio must be < 2, and HER2 copy number < 6 signals/cell), but otherwise FISH/CISH is not required if IHC is 0 or 1+ by institutional standards. Must be candidates to receive endocrine therapy and palbociclib as first-line treatment for their advanced disease. Patients will be considered eligible for study enrollment if they have started on treatment with a standard dose and schedule of palbociclib and endocrine therapy (aromatase inhibitor or fulvestrant) as long as they have not started treatment for longer than 4 weeks from time of study enrollment, and must meet all other eligibility criteria. Patients must have measurable disease by RECIST v.1.1 or bone disease as their only site of disease (with bone lesions confirmed by CT, MRI or bone X-ray). No prior treatment with chemotherapy for a diagnosis of locoregionally recurrent or metastatic breast cancer is allowed. 18 years of age ECOG Performance Status of 0-1 Postmenopausal women defined as women with: o Prior bilateral surgical oophorectomy, or o Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months or follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol blood levels in their respective postmenopausal ranges. Premenopausal women will be considered eligible for study participation if they are receiving medical ovarian suppression with luteinizing hormone-releasing hormone (LHRH) agonists with documented estradiol blood levels in their respective postmenopausal ranges. Archive tumor tissue (obtained from a biopsy or surgical resection done within 4 months from study enrollment) availability is required for patient participation. Understand and provide written informed consent prior to initiation of any study-specific procedures.

2 Exclusion Criteria: Lack of archive tumor tissue from a biopsy or surgical resection done within 4 months of study enrollment. Patients will be given an option to have a repeat biopsy if they had a diagnostic tumor biopsy intended for use in the current study that was performed more than 4 months prior to analysis, or there is insufficient tissue from the initial biopsy to complete the analysis. Otherwise, the patient will be excluded from study participation. Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for 4 weeks prior to enrollment. Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent. Treatment: Eligible patients must be candidates for standard first line treatment for a diagnosis of metastatic breast cancer with Palbociclib 125 mg, orally once daily on day 1 to day 21 of every 28-day cycle followed by 7 days off treatment PLUS 1. An aromatase inhibitor: One of the following aromatase inhibitors will be allowed: a. Letrozole 2.5 mg po daily b. Anastrozole 1 mg po daily c. Exemestane 25 mg po daily OR 2. Fulvestrant 500 mg administered intramuscularly on days 1, 15 of cycle 1, then on day 1 of subsequent 28 day cycles. Coordinator: Dawn Poller Dawn.Poller@jefferson.edu Title: A Phase III Prospective Double Blind Placebo Controlled Randomized Study Of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer (BR.31). PI: Rita Axelrod, MD Sponsor: NCIC CTG A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Paclitaxel in Combination with Reparixin Compared to Paclitaxel Alone as Front-Line Therapy for Metastatic Triple-Negative Breast Cancer. PI: Laura Austin, MD Sponsor: DOMPE NRG GY006: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal ECOG EA3132: Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) SWOG 1505: A Randomized Phase II Study of Perioperative mfolfirinox Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma SWOG 1416: Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer :

CTSU encourages sites to utilize the portal for submissions; it will become mandatory at a future date.

3 Regulatory Submission Portal Sites can now submit regulatory documents via the Regulatory Submission Portal on the CTSU website. The portal provides sites with an easier and more efficient way of submitting regulatory information to the CTSU Regulatory Office, as well as a mechanism for tracking the submission s progress. CTSU encourages sites to utilize the portal for submissions; it will become mandatory at a future date. The Regulatory Submission Portal has been tested by select pilot sites since early spring and is now released to production for use by all CTSU sites. The Regulatory Submission Portal can be found in the Regulatory Submission subtab under the Regulatory tab located at the top of all pages on the CTSU members website. The Regulatory Submission Portal will allow sites to upload files electronically or generate a fax/ cover sheet with a unique barcode. Each submission will be assigned a Packet ID and Tracking Code and sites can verify on the CTSU website the details of each Packet ID including real-time status updates. For details on how to use the system, sites may access training materials on the Regulatory Submission Portal main screen; there is an icon for the User Guide and Quick Start Guide. E5103, A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer, step 3 registration to the EL112LAB substudy, will close to accrual on July 29, All patients on EL112LAB from E5103 and PACCT-1 are to be followed according to the protocol. If you have questions, ecog.tst@jimmy.harvard.edu ECOG Cont. E1412, Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma), addendum #7 activated in CTSU on July 7, 2016.This amendment is in response to a Lenalidomide Action Letter from Dr. Howard Streicher dated July 5, This Action Letter has been processed and can be found on the ECOG webpage ( Accrual of new patients must be suspended until the IRB of record has reviewed and approved this amendment. Patients currently receiving active protocol treatment may continue on study provided they are informed of the new risks identified as part of the CAEPR and Risk List update in the Action Letter. The ECOG-ACRIN Cancer Research Group's Boston Operations Office relocated to 28 State Street, Suite The new address and main phone number is: ECOG-ACRIN Cancer Research Group Operations Office-Boston 28 State Street, Suite 1100 Boston, MA Phone: (857) Protocol documents will be updated on a rolling basis. EFFECTIVE IMMEDIATELY, please send ALL mail and package shipments that you previously mailed to 900 Commonwealth Ave to the new address, regardless of the protocol document language. Note: Shipments of laboratory samples should continue per protocol requirements. Please note the following changes in phone numbers: NEW PHONE NUMBER Main number (857) Drug team (857) Fax numbers: New Fax Numbers are active for Data Management and Drug Orders, effective immediately. NEW FAX NUMBER Data Management (617) Drug Orders (617) Please continue to use the existing fax numbers for all other fax machines as shown below until further notice. NEW FAX NUMBER Membership (617) Lab pre-study (617) EA2133 (InterAACT) (617)

ECOG cont. If you experience difficulty reaching the Boston Office, please call the Philadelphia headquarters staff at (215) 789-7009 during normal business hours (Eastern Time).

Professionals, please follow the Mindflash link below. Completing this course provides 2.0 CEUs towards those involved in SoCRA Certifications. Link to Course: https://coccg813.mindflash.

4 ECOG cont. If you experience difficulty reaching the Boston Office, please call the Philadelphia headquarters staff at (215) during normal business hours (Eastern Time). ECOG-ACRIN Semi-Annual Meeting: If you were unable to attend the Spring 2016 EA Group Meeting and are interested in viewing materials provided at the General Education Session for Clinical Trial Professionals, please follow the Mindflash link below. Completing this course provides 2.0 CEUs towards those involved in SoCRA Certifications. Link to Course: (NOTE: Mindflash supports the following browsers Chrome-latest version, Firefox 25+, Safari 7+, and Internet Explorer 10+) Please contact the EA Clinical Education and Awareness Team with any questions or course assistance needed. EA Clinical Education and Awareness Team ECOG-ACRIN Cancer Research Group - Headquarters 1818 Market Street, Suite 1100 Philadelphia, PA EAClinEd@ecog-acrin.org NRG Oncology Semi-Annual Meeting: During the Semi-Annual meeting on July 14-16, 2016 in Dallas TX, NRG Oncology recognized its top accruing member sites to the National Clinical Trial Network (NCTN) and the NCI Community Oncology Research Program (NCORP). Accrual totals are based on enrollments on NCTN and NCORP trials credited to NRG Oncology during the past year. Thomas Jefferson ranked 5 th out of 146 Main Member Sites with 52 accruals in NSABP B-51/RTOG 1304, A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes after Neoadjuvant Chemotherapy, effective immediately, sites NOT using the NCI Central IRB (CIRB) NRG cont. and that have not yet submitted an Amendment #3 approval to the CTSU will not be able to enroll patients until IRB approval has been submitted to CTSU. Patient enrollment cannot occur at non-cirb sites because of system limitations: electronic systems were updated to reflect only Amendment #3 parameters. As a result, sites are unable to fulfill procedures outlined in Amendment #2. After Amendment #3 is approved locally, sites are to enroll patients under Amendment #3 parameters. RTOG 1201, A Phase 2 Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-paclitaxel for Locally Advanced Pancreatic Cancer, closed to accrual on 6/30/2016. After an accrual assessment by the Clinical Investigations Branch of the Cancer Therapy Evaluation Program (CTEP) it was determined that the trial would not be completed within a reasonable timeframe per CTEP s Early Phase Trial Slow Accrual guidelines. Please note there are no increased safety risks that led to this decision of closure. Study-specific followup and data submission will cease for all patients. GY004, A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and GY005 A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS), please be advised that a study-specific 1572 and Conflict of Interest Forms (COI) will no longer be required to participate in NRG-GY004 and NRG-GY005. The study-specific 1572 was the trigger for NRG Oncology to request Firecrest access for all investigators listed on the 1572 to complete the mandatory protocol and/or GCP training(s). New Process To request investigator and/or other staff access to Firecrest, please complete the excel document entitled Firecrest Site and User Master Spreadsheet, that is on the CTSU web site, under the LPO tab. When completed, submit to NRG-GY-RegulatorY@nrg oncology.org with the following subject line in the [Study Number(s)] Request for Firecrest Access [NCI CTEP Institution Code(s)] Failure to include the above subject line, may delay the request.

Please remember to utilize the regulatory central email address RNORegulatory@jefferson.

status, and/or updates on the status of the a specific trial. The document repository will continue to be maintained with the current documents, for you download. NSABP B-43 (09F.

5 Please remember to utilize the regulatory central address when requesting personnel updates, requests for participation on a specific trial(s), issues with consent(s), requests for consent(s)/ consent addendum(s), repository questions, IRB training status, and/or updates on the status of the a specific trial. The document repository will continue to be maintained with the current documents, for you download. NSABP B-43 (09F.20) Protocol Amendment 8 and Trastuzumab Action Letter R0848 (10F.75) Protocol Amendment 6 and Consent revisions GOG-0209 (04F.199) NSABP B-47 (11F.106) Protocol Amendment 7 R1304/NSABP B-51 (13F.419) Protocol Amendment 3 and Consent revisions E2805 (06F.302) Change in TJU PI; Updated network consent addendum E1505 (07F.356) Regulatory cont. E2108 (11F.283) S1007 (11F.272) R0521 (06F.49) R0920 (10F.312) R1010 (11F.62) Protocol Amendment 5 and Trastuzumab Action Letter EAY131 MATCH (15F.583) Addendum 4 E7208 (11F.252) Protocol Amendment 10 and Consent revisions R0938 (12F.40) R0839 (11F.91) E2211 (13F.414) R1008 (11F.54) E1412 (13F.502) NSABP B-31 ( R) R1114 (11F.564) E2408 (11F.147) Upcoming Event: SKCN CRA Research Update September 14, 2016 Philadelphia, PA

6 Save the Dates: SOCRA Annual Conference: October 1 and 2, 2016 Montreal Canada SKCN Social Workers Meeting: October 7, 2016 Philadelphia PA ECOG-ACRIN Fall Group Meeting: November 10-12, 2016 Orlando FL SKCN Patient Navigators Meeting: November 11, 2016 Philadelphia PA JOG Annual Investigators Meeting: November 17, 2016 Philadelphia PA SKCN CRA Research Update: December 14, 2016 Philadelphia PA NRG Oncology Semiannual Meeting: February 9-12 Houston TX The Clinical Research E-News Archive is now located on the Sidney Kimmel Cancer Center webpage under the SKCN Member Area: Sidney Kimmel Cancer Network Homepage: -This page contains links to the Remote Access Portal as well as the clinical trial document repository. Contact Information: Cynthia Perez, CCRP NCTN Manager Editor, E-Newsletter Joshua Schoppe, MPH, CCRP Senior Director, RNO Suzanne Jorfi, BS, CCRP Regulatory Manager Office: cynthia.perez@jefferson.edu Office: joshua.schoppe@jefferson.edu Office: suzanne.jorfi@jefferson.edu NRG Oncology, ECOG-ACRIN, CTSU or E-Newsletter inquiries RNO and SKCN inquiries Regulatory Update inquiries o CIRB Protocol Support Unit RNORegulatory@jefferson.edu Regulatory Related inquires For URGENT ISSUES, Please call the RNO cellphone at

The Clinical Research E-News

The Clinical Research E-News Volume 7: ISSUE 1: January 16, 2015 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Featured Trials