Connections. Academic and Community Cancer Research United (ACCRU) continues to expand our portfolio of cancer treatment

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1 Connections Vol. 7 No. 1 Spring 2017 Inside this issue Meeting news...2 Spring ACCRU Scientific Program Overview ACCRU to exhibit at ASCO 2017 Membership news...2 Top accruing members ACCRU welcomes new members Trial highlights...3 Trial tests vaccine to treat triple negative breast cancer New trial brings precision medicine approach to screening, treating metastatic colorectal cancer Operations updates...5 ACCRU welcomes Fawn Hangge as new program manager Updates to ACCRU systems improve study feasibility processes Message from the chair Academic and Community Cancer Research United (ACCRU) continues to expand our portfolio of cancer treatment Axel Grothey, M.D. and symptom management trials. With 16 open trials and 13 trials in development, we are evaluating innovative treatment options for many types of cancer. In this issue, we profile two exciting ACCRU trials. Kathryn Ruddy, M.D., M.P.H., an oncologist at Mayo Clinic s Rochester, Minnesota campus, is the principal investigator for a recently opened trial testing a promising immunotherapy for patients with triple negative breast cancer (TNBC). John Strickler, M.D., an oncologist at Duke University, is leading a trial that will use genomic profiling to screen and then recommend treatment for patients with metastatic colorectal cancer. We invite you to join us to learn more about these trials and our complete scientific portfolio at ACCRU s Scientific Program Overview on Thursday, May 11 in Chicago. At the meeting, you will also have the opportunity to meet Fawn Hangge, who joined ACCRU as our new program manager in February. She Fawn Hangge has already had the opportunity to work with many of our industry sponsors and members. You ll also want to be sure to visit our booth at American Society of Clinical Oncology (ASCO) on June 3-5, 2017, in Chicago. We look forward to seeing you this spring. Axel Grothey, M.D. ACCRU Chair Academic and community investigators partner to develop new cancer therapies

2 Membership news Top accruing member sites Thank you to the memberships listed below for their efforts to enroll patients in ACCRU trials. Academic memberships Dana-Farber Cancer Institute, Boston, Massachusetts Mayo Clinic campus in Rochester, Minnesota NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois ACCRU welcomes new members The ACCRU leadership extends a warm welcome to the newest members: Carolina Health Care System, Charlotte, North Carolina Intermountain Healthcare, Salt Lake City, Utah St. Elizabeth Medical Center, Edgewood, Kentucky St. Luke s Mountain States Tumor Institute, Inc., Boise, Idaho Community memberships Cancer Center of Kansas, Wichita, Kansas FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina Illinois CancerCare Peoria, Peoria, Illinois Meeting news ACCRU spring Scientific Program Overview, Thursday, May 11 ACCRU staff and investigators invite you to attend the spring ACCRU Scientific Program Overview on Thursday, May 11, 5 to 7 p.m., at the Crowne Plaza Hotel, Midway Auditorium, in Chicago. The program will include: Reception from 5 to 6 p.m., for ACCRU members, potential members and industry sponsors. Scientific Overview presentation from 6 to 7 p.m., highlighting ACCRU s portfolio of trials for current ACCRU members and potential members. Note that this meeting is included on the Alliance for Clinical Trials in Oncology meeting agenda. However, no registration is required, and all Alliance members are welcome to attend. ACCRU to exhibit at ASCO 2017 Visit ACCRU at ASCO 2017 in Chicago June 3-5, at McCormick Place at booth Meet ACCRU investigators and staff, learn about ACCRU trials and explore the network s capabilities. 2 ACCRU Connections Spring 2017

3 Trial highlights Trial tests vaccine to treat triple negative breast cancer Approximately 15 percent of all breast cancer patients have triple negative breast cancer (TNBC), an aggressive form of cancer that has a poor prognosis. Patients with TNBC do not benefit from most approved available targeted therapies, such as trastuzumab, pertuzumab and tamoxifen. A recently opened ACCRU trial is evaluating the benefit of immunotherapy for patients with TNBC. ACCRU trial RU011501I is testing a vaccine to stimulate the immune system of patients with TNBC who are disease-free following conventional therapy. Kathryn Ruddy, M.D., M.P.H. The vaccine will encourage the production of T cells, hopefully preventing the re-emergence of TNBC. Targeted enrollment for the study is 280 patients. Immunotherapy holds tremendous potential for improving the treatment of breast cancer. We are excited that this trial may help us cure more patients with triple negative disease, says Kathryn Ruddy, M.D., M.P.H., associate professor of Oncology on Mayo Clinic s Rochester campus and principal investigator for the trial. The phase II, double-blind, randomized trial is evaluating vaccination with folate receptor alpha (FRα) peptide vaccine with GM-CSF as adjuvant therapy following oral cyclophosphamide, compared to GM-CSF/placebo, to prevent recurrence of TNBC. Edith Perez, M.D., professor of Medicine, and Keith Knutson, Ph.D., professor of Immunology on Mayo Clinic s campus in Jacksonville, Florida, are study co-chairs for the trial. Trial objectives Trial objectives are to: Show that FRα peptide vaccine will prolong the disease-free survival in patients with triple negative breast cancer. Determine whether high level of antibody and cellular immune response toward the FRα at baseline is a prognostic factor for vaccine immune response and/or cancer relapse. Determine whether the level of FRα expression at baseline is a prognostic factor for vaccine immune response and/or cancer relapse. For more information For more information on this trial, contact the ACCRU Research Coordinating Center by at accru@mayo.edu or phone at ACCRU Connections Spring 2017

4 New ACCRU trial brings precision medicine approach to screening, treating metastatic colorectal cancer Colorectal cancer is the second leading cause of cancer death in the United States. While overall survival for patients with metastatic colorectal cancer has improved over the last two decades, there is still great potential to build on this progress using targeted therapies. Some patients are already receiving these treatments. However, the challenge for physicians has been to identify patients who are candidates and then provide access to the targeted treatment that will offer them the most benefit. A new ACCRU trial is designed to address these challenges and provide efficient, rapid screening and treatment recommendations for patients with metastatic colorectal cancer. In this trial, called COLOMATE (COlorectal and Liquid biopsy Molecularly Assigned ThErapy), John Strickler, M.D. researchers will conduct genomic profiling on blood samples from patients with refractory disease and then recommend the appropriate treatment based on the identification of actionable genomic variations. The trial is scheduled to open by the end of the year and will enroll 500 patients. John Strickler, M.D., principal investigator for the trial, explains the importance of the study s design in directing individualized care. To capture the value of genomic testing, it is critical to have an efficient screening process, provide convenient access to clinical trials and offer treatments with a high probability of clinical benefit. Our study design addresses these issues by using blood samples for genomic profiling. This screening approach spares the patient an invasive tumor biopsy, and offers rapid and cost-effective genomic profiling. Using these liquid biopsies, we can more quickly identify patients who are candidates for targeted treatment and recommend how they can access the appropriate therapy, says Dr. Strickler. Dr. Strickler is a medical oncologist and assistant professor of Medicine at Duke University. Trial objectives Goals for the trial are to: Perform blood-based genomic profiling on patients with chemotherapy refractory metastatic colorectal cancer to facilitate accrual to molecularly assigned therapies. Obtain clinically annotated tumor tissue and patient-matched tumor DNA from peripheral blood to allow clinically annotated genomic analyses. Describe the clinical activity of molecularly assigned therapies in patients with chemotherapy refractory metastatic colorectal cancer. Define the time between informed consent and receipt of assigned therapy. Explore the correlation between tissue and blood-based molecular profiles and clinical outcomes (ORR, PFS, OS). For more information For more information on this trial, contact the ACCRU Research Coordinating Center by at accru@mayo.edu or phone at ACCRU Connections Spring 2017

5 Operations updates ACCRU welcomes Fawn Hangge as new program manager We are pleased to welcome Fawn Hangge as program manager for ACCRU. Fawn will work closely with ACCRU leadership to implement the ACCRU business plan and oversee staff in the ACCRU Research Coordinating Center. Fawn brings a breadth of experience to her new role. She joined Mayo Clinic in 2014 as a senior account manager with Global Business Fawn Hangge Solutions. In this position, Fawn worked with a variety of employers, healthcare organizations, insurance companies and wellness consultants nationwide, focusing on strategic planning, implementation, compliance and ongoing management of population health initiatives. Prior to joining Mayo Clinic, Fawn served for ten years as a health educator and program manager at Olmsted Medical Center in Rochester, Minnesota. In this role, she was responsible for overall program management, including strategic planning, budget management, staff leadership, and process improvement in the areas of bariatric surgery, nutrition education, diabetes education, and employee wellness. Fawn holds a bachelor s degree in School and Community Health Education from Winona State University and has earned multiple certifications in the areas of organizational health and leadership. Fawn replaces Desirae Sagdalen, who previously served as program manager for ACCRU. We thank Desirae for her outstanding service to ACCRU and wish her well in her new position as a manager in Mayo Clinic Pharmacy Operations. Updates to ACCRU systems improve study feasibility processes The ACCRU Business Management System (ABMS) now offers ACCRU members enhanced features to help sites complete study feasibility tasks more easily and efficiently. When members log in to the system, they will now see a separate webpage that includes all study feasibility information for their membership. The updated system allows members to: View a list of study feasibility forms that need to be completed and a list of those forms already completed by the membership Select the treating locations for study participation for each ACCRU trial Receive site selection letters and either accept for decline study participation Contact the ACCRU Research Coordinating Center at accru@mayo.edu or with questions about the new system. For more information, see the ABMS user manual, which is located under the Clinical Research Associate tab on the ACCRU members website at accru.org. 5 ACCRU Connections Spring 2017

6 Contact ACCRU ACCRU Research Coordinating Center 200 First Street SW Rochester, Minnesota Phone: Fax: Website: accru.org ACCRU YouTube Channel: youtube.com/user/accrunetwork By ACCRU Operations Office: Finance Office: Membership Roster Office: Regulatory Affairs Office: ACCRU Connections Editorial Staff Medical Editor Axel Grothey, M.D. Oncologist Mayo Clinic ACCRU Chair Managing Editor Sharon Rosen Public Affairs Editorial Board Fawn Hangge Program Manager Michelle Hewlett Research Protocol Specialist Debbie Van Esch Supervisor-Operations Office 6 ACCRU Connections Spring 2017