A phase II randomized open-label study for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) gene mutation, will test the EGFR inhibitor osimertinib with or without ramucirumab.

The study, HCRN LUN18-335, is now open to accrual at The University of Texas MD Anderson Cancer Center in Houston; Columbia University Irving Medical Center in New York; Fred Hutchinson Cancer Research Center in Seattle; Georgetown Lombardi Comprehensive Cancer Center in Washington, DC; Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis; Moffitt Cancer Center in Miami; New York University Cancer Institute in New York; Providence Cancer Institute in Portland, Oregon; Robert H. Lurie Comprehensive Cancer Center of Northwestern University in Chicago; Rush University Medical Center in Chicago; Summit Health Cancer Center in Florham Park, New Jersey; and the University of Virginia Cancer Center in Charlottesville, Virginia. Read More

A multi-institutional single-arm study led by Rachel Sanborn, MD, of the Earle A. Chiles Research Institute, a division of Providence Cancer Institute, is testing the immunotherapy drug durvalumab followed by chemoradiation and consolidation durvalumab for adults with previously untreated stage III non-small cell lung cancer (NSCLC).

The study, HCRN LUN18-357, is currently enrolling participants at Providence Cancer Institute in Portland, Oregon; HealthPartners Institute in Minneapolis; Rush University Medical Center in Chicago; Summit Health Cancer Center in Florham Park, New Jersey; and Cancer Center of Kansas in Wichita.

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Hoosier Cancer Research Network’s Melanoma Clinical Trial Working Group recently appointed a new co-chair, Alan Tan, MD, director of GU Medical Oncology and assistant professor in the Department of Internal Medicine, Division of Hematology, Oncology and Cell Therapy at Rush Medical College.

Dr. Tan (pictured left) joins current co-chairs Ragini R. Kudchadkar, MD, of Emory University and Timothy Kuzel, MD, FACP, also of Rush University, in this leadership role. His research interests are in designing and implementing novel immunotherapies and targeted therapies in melanoma and genitourinary cancers.

Prior to joining Rush University, Dr. Tan served as clinical assistant professor at the University of Arizona College of Medicine in Phoenix, where he worked on phase I, II, and III clinical trials. He received his medical degree from St. George’s University School of Medicine and completed his residency and fellowship in hematology/oncology at Saint Louis University School of Medicine. Read More

David J. McConkey, PhD (pictured left), professor of urology and oncology at The Johns Hopkins University School of Medicine, and Gaorav P. Gupta, MD, PhD, assistant professor of radiation oncology, biochemistry and biophysics at the University of North Carolina School of Medicine, were recently appointed as co-chairs of Hoosier Cancer Research Network’s Correlative Sciences Clinical Trial Working Group. The group includes investigators from several HCRN member institutions who advise investigators on correlative research objectives for HCRN studies that are in development.

Dr. Gupta, a radiation oncologist specializing in breast cancer at UNC Lineberger Comprehensive Cancer Center, received his MD, PhD, from the Tri-Institutional MD-PhD Program offered by Weill Cornell Medicine, The Rockefeller University, and Memorial Sloan Kettering Cancer Center. He completed his residency training in radiation oncology at Memorial Sloan Kettering Cancer Center, where he served as chief resident his during his final year. His expertise in breast cancer began at Sloan Kettering Institute, where he studied the mechanisms of tissue-specific metastasis in breast cancer and the critical role of the DNA damage sensor protein Mre11 in breast cancer prevention. Read More

This month, Hoosier Cancer Research Network features our member institution Rutgers Cancer Institute of New Jersey and Coral Omene, MD, PhD, medical oncologist at Rutgers Cancer Institute and Assistant Professor of Medicine at Rutgers Robert Wood Johnson Medical School.

Research Interests and Expertise:

Dr. Omene is a medical oncologist with a passion for women’s health who is dedicated to the care of treating and managing a diverse pool of breast cancer patients. She has devoted much of her research toward translating novel laboratory observations into discoveries to better care for breast cancer patients, with a particular focus on triple negative breast cancer (TNBC), which is known to be among the most aggressive breast cancers, with a poor prognosis, especially among African American women.

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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 (HCRN) is currently seeking graduate students for paid internships. HCRN is an independent nonprofit contract research organization based in Indianapolis, Ind., that specializes in early phase, multi-center, investigator-initiated oncology clinical trials. Our studies are conducted through a nationwide network of more than 450 academic and community sites.
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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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