Three HCRN investigator-initiated clinical trials were highlighted during the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting held virtually June 4-8.

Deepak Kilari, MD, (pictured left), associate professor at the Medical College of Wisconsin and a medical oncologist at the MCW Cancer Center, presented a poster (Abstract #TPS4591) on HCRN GU18-343, the phase II ABATE study of cabozantinib in combination with atezolizumab as neoadjuvant treatment for muscle-invasive bladder cancer (MIBC).

Michael B. Atkins, MD, (pictured center), deputy director of the Georgetown Lombardi Comprehensive Cancer Center and professor of oncology and medicine (hematology/oncology) at Georgetown University School of Medicine, presented a poster discussion (Abstract #4510) on HCRN GU16-260 – Cohort B, a phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment -naïve patients with advanced non-clear cell renal cell carcinoma (nccRCC).

Matt D. Galsky, MD, FASCO, (pictured right), professor of medicine (hematology/medical oncology) at Icahn School of Medicine at Mount Sinai and co-director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute, presented an oral abstract (Abstract #4503) on HCRN GU16-257, a phase II trial of gemcitabine, cisplatin, plus nivolumab with selective bladder sparing in patients with MIBC. Read More

Hoosier Cancer Research Network investigators presented the ongoing study LUN18-335, RAMOSE: An open-label randomized Phase II study of osimertinib with or without ramucirumab in TKI-naïve EGFR-mutant metastatic non-small cell lung cancer (NSCLC), during the World Conference on Lung Cancer earlier this year.

Led by Xiuning Le, MD, PhD, of the University of Texas MD Anderson Cancer Center, the goal of this multicenter study is to determine the efficacy of the combination of osimertinib and ramucirumab in treatment-naïve EGFR-mutant non-small cell lung cancer. An earlier phase I study demonstrated the safety and feasibility of this combination.

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This month, Hoosier Cancer Research Network features our member institution Summit Health Cancer Center in Florham Park, New Jersey, and David Gallinson, DO, a medical oncologist.

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Researchers from the University of North Carolina Lineberger Comprehensive Cancer Center, along with colleagues from Fox Chase Cancer Center, Icahn School of Medicine at Mount Sinai, Fred Hutchinson Cancer Research Center at the University of Washington, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, The University of Chicago Medicine Comprehensive Cancer Center, Memorial Sloan Kettering Cancer Center, and USC Norris Comprehensive Cancer Center, presented data from the HCRN GU15-217 study, also known as UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch, during the AACR Annual Meeting 2021.

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This month, Hoosier Cancer Research Network features our member institution Fox Chase Cancer Center, and Daniel M. Geynisman, MD, associate professor, Hematology/Oncology and a medical oncologist at Fox Chase Cancer Center.

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Based on encouraging preliminary data, researchers at Mayo Clinic in Rochester, Minn., are leading a randomized multi-site phase II study for adults with metastatic, recurrent, or locally advanced unresectable gastric or gastroesophageal (GE) junction adenocarcinoma that tests a novel serial approach to treating these cancers, using immunotherapy, anti-angiogenic therapy, and chemotherapy.

The primary goal of the study, SEQUEL (HCRN-GI18-333), is to evaluate the best overall response rate of the chemotherapy drug paclitaxel plus the vascular endothelial growth factor-2 (VEGF-2) inhibitor ramucirumab plus either alternating or concurrent pembrolizumab, a PD-1 inhibitor, following induction pembrolizumab in these types of cancer.

Researchers believe immunotherapy drugs, like pembrolizumab, might make tumors more sensitive to treatment with chemotherapy and drugs that target blood formation.

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Hoosier Cancer Research Network investigators presented a poster highlighting GI17-319, a gastric and esophageal adenocarcinoma study, during the AACR Annual Meeting 2021.

A single arm, multi-center phase 2 trial of mFolfox6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas, GI17-319 examined whether adding the anti-PD-L1 antibody avelumab to the chemotherapy drug trastuzumab and FOLFOX chemotherapy would result in a greater response rate than expected with trastuzumab and FOLFOX alone in HER2-amplified gastroesophageal cancer.

Researchers concluded the combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated evidence of activity, and response rate and median progression-free survival compared favorably to results expected with trastuzumab plus chemotherapy from historical data. These outcomes corroborate with results from prior small studies of chemotherapy, trastuzumab, and immune checkpoint inhibitors in patients with HER2-amplified metastatic gastroesophageal adenocarcinoma and demonstrate the potential for the addition of immune checkpoint inhibitors in this setting. Read More

This month, Hoosier Cancer Research Network features our member institution University of North Carolina Lineberger Comprehensive Cancer Center and Joshua F. Zeidner, MD, associate professor of medicine, chief of leukemia research, and associate chief of research, hematology at UNC Lineberger.

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The moment a cancer patient learns about their cancer diagnosis, they begin one of the most important conversations they will have with their doctor. Many patients are fortunate to have a clear treatment plan, tested and proven effective through rigorous clinical trials. For others, often diagnosed in the latter stages of disease progression, standard options are limited and clinical trials may be the best path forward.

These conversations are daily occurrences for investigators active in the Hoosier Cancer Research Network. The clinical trial options they present to patients are the result of many months, sometimes years, of a highly coordinated process of protocol development and activation, the inner workings of which are invisible to the patient but as complex as any mechanical system that depends on all parts functioning in harmony. A break anywhere in the process can cause the whole machinery to grind to a halt.

Delays in study development can occur in many stages, including early discussions with research colleagues, contract and budget negotiations with sites and funders, scientific and regulatory review, and site activation. While a short delay in any part of the process may not seem significant, delays can accumulate over time. Read More

Noah M. Hahn, MD, deputy director of Johns Hopkins Greenberg Bladder Cancer Institute and sponsor-investigator of the multi-site Hoosier Cancer Research Network ADAPT-BLADDER study, GU16-243, highlighted the Phase I findings during a poster session at the Society of Urologic Oncology’s 2020 Annual Meeting in December.

The phase I portion of the clinical trial was open to adults with non-muscle invasive bladder cancer (NMIBC) who were previously treated with the Bacillus Calmette-Guerin (BCG) vaccine. The study tested the immunotherapeutic agent durvalumab combined with BCG, or durvalumab combined with radiation therapy. The primary objective of the phase I study was to determine the recommended Phase II dose for each combination regimen.

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Hoosier Cancer Research Network (HCRN) received the Indiana Cancer Consortium (ICC) Sustained Excellence Award during the ICC’s 2021 Annual Meeting on April 21. The award is presented to organizations that have longstanding contributions to the consortium and recent notable achievements.

The ICC launched from a shared vision of the Indiana State Department of Health, the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, the Indiana University Richard M. Fairbanks School of Public Health, and the American Cancer Society, Great Lakes Division. Over the past decade, the ICC has grown to include more than 400 members, including organizations and individuals, who work collaboratively to reduce Indiana’s cancer burden. Read More

This month, Hoosier Cancer Research Network features our member institution Froedtert & the Medical College of Wisconsin in Milwaukee, Wis., and Deepak Kilari, MD, a medical oncologist with specialization in genitourinary cancers.

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This month, Hoosier Cancer Research Network features our member institution Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, Mo., and Jian Li Campian, MD, PhD, a medical oncologist with specialization in neuro-oncology and immunotherapy.

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This month, Hoosier Cancer Research Network features our member institution Cleveland Clinic Cancer Center and medical oncologist Shilpa Gupta, MD. Dr. Gupta is a genitourinary oncologist and the leader of the bladder cancer program at the Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio. She is also a member and co-chair elect of Hoosier Cancer Research Network’s Genitourinary Clinical Trial Working Group. Read More

Hoosier Cancer Research Network investigators recently presented abstracts during the 2021 Gastrointestinal Cancers Symposium. The abstracts included a poster featuring the HCRN GI14-198 study, led by Walid Shaib, MD, of Winship Cancer Institute at Emory University, and a trials in progress poster featuring HCRN GI19-405, led by Aiwu Ruth He, MD, of Georgetown University Lombardi Comprehensive Cancer Center.

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Richard Kim, MD, service chief of Medical Gastrointestinal Oncology and senior member in the Gastrointestinal Oncology Department at Moffitt Cancer Center, has been appointed as a co-chair of the Hoosier Cancer Research Network (HCRN) Gastrointestinal Clinical Trial Working Group. He joins fellow co-chairs Bassel El-Rayes, MD, of Winship Cancer Institute at Emory University, and Autumn McRee, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center.

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This month, Hoosier Cancer Research Network features our member institution The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and medical oncologist Dwight Owen, MD, MS. Dr. Owen is a member of the Translational Therapeutics Program at the OSUCCC – James.

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This month, Hoosier Cancer Research Network features our member institution Vanderbilt-Ingram Cancer Center (VICC) in Nashville, Tenn., and Nancy B. Davis, MD, associate professor of medicine and VICC senior medical director for Cancer Care Network and Strategy, Division of Hematology/Oncology, Vanderbilt University Medical Center. Read More

The Hoosier Cancer Research Network multi-center BRE12-158 study on triple-negative breast cancer (TNBC), led by Indiana University Melvin and Bren Simon Comprehensive Cancer Center, was recently presented as a Spotlight Poster Discussion during the 2020 San Antonio Breast Cancer Symposium virtual meeting.

The correlative analysis from the study, “A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer,” found patients with circulating tumor DNA (ctDNA) after neoadjuvant chemotherapy (NAC), who had a presence of TP53 mutations, had a greater chance of rapid disease recurrence.

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Hoosier Cancer Research Network recently welcomed Vivian Cintron, PhD, MBA, as its first chief operating officer. In her new role, she will work closely with HCRN’s executive director, Cyndi Burkhardt, and the management team to support company operations and strengthen relationships with investigators, key opinion leaders, and industry collaborators.

Dr. Cintron is a molecular biologist and geneticist with more than 25 years of executive global experience in medical, scientific affairs, clinical trials, and strategic business development, working with Roche Diagnostics, DiaSorin, and Cepheid. She is a strategic visionary with a strong business acumen and comprehensive knowledge in the area of oncology therapeutics. A former captain in the US Army Reserve, Dr. Cintron holds an executive leadership certification from Cornell University, completed postdoctoral trainings at the National Institutes of Health and Eli Lilly and Co., and obtained an MBA and Master of Science in Strategic Management from Indiana University Kelly Business School. Read More