Researchers participating in GI14-186, a Hoosier Cancer Research Network study for patients with metastatic colorectal cancer (mCRC), recently reported their findings in the journal Cancer Immunology, Immunotherapy.

The single-arm phase Ib study, led by researchers at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, tested the hypothesis that the addition of pembrolizumab to modified FOLFOX6 (mFOLFOX6), an established therapy for mCRC, could safely and effectively improve patient outcomes. The main purpose of the study was to determine median progression free survival (mPFS). Secondary objectives included disease assessments for objective response rate, disease control rate, and delayed response rate; disease assessment per immune related response criteria; overall survival (OS); and safety and tolerability.

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This month, Hoosier Cancer Research Network features our member institution UT Southwestern Harold C. Simmons Comprehensive Cancer Center in Dallas, Texas, and Hans Hammers, MD, PhD, an associate professor of internal medicine in the Division of Hematology and Oncology at the UT Southwestern Medical School and the first Eugene P. Frenkel, M.D. Scholar in Clinical Medicine.

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Results from a Hoosier Cancer Research Network study in triple negative breast cancer, led by researchers at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, were recently published in npj Breast Cancer.

The purpose of the multi-site, phase II study, BRE09-146, “PARP Inhibition After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer or ER/PR+, HER2 Negative With Known BRCA1/2 Mutations,” was to evaluate 2-year disease-free survival (DFS) in patients treated with single agent cisplatin versus cisplatin in combination with the PARP inhibitor rucaparib following preoperative chemotherapy. Researchers also evaluated the safety and tolerability of this combination. Kathy D. Miller, MD (pictured), was the sponsor-investigator of the study. Dr. Miller is the Ballvé Lantero Professor of Oncology and a professor of medicine in the Indiana University School of Medicine and associate director of clinical research in the IU Simon Comprehensive Cancer Center. Read More

Hoosier Cancer Research Network announces the appointment of Shilpa Gupta, MD, of the Cleveland Clinic, and Rana McKay, MD, of the University of California San Diego, as co-chairs of the organization’s Genitourinary Clinical Trial Working Group.

The new co-chairs succeed Noah Hahn, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Matthew Galsky, MD, of the Icahn School of Medicine at Mount Sinai; and Guru Sonpavde, MD, of Dana-Farber Cancer Institute, who led the group for a decade of highly productive collaborative research. In 2020 alone, HCRN investigators presented seven abstracts at scientific meetings, including an oral abstract at the American Society of Clinical Oncology Annual Meeting, and published a manuscript in the Journal of Clinical Oncology. More than 75 investigators and 45 institutions compose the working group, and the group’s portfolio includes about 20 active studies and approved Letters of Intent. Read More

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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