A new Hoosier Cancer Research Network clinical trial studying Merkel cell carcinoma is currently recruiting subjects.

The trial, A Single Arm Phase II Study with Safety Run-in of Peptide Receptor Radionuclide Therapy (PRRT) in Combination with Immunotherapy for Patients with Merkel Cell Cancer (HCRN-MCC20-443; iPRRT Study), is led by Pashtoon Kasi, MD, MS, of Cornell University and is currently recruiting subjects at New York-Presbyterian/Weill Cornell Medical Center.

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Researchers participating in the study known as ADAPT-BLADDER, or HCRN GU16-243, recently reported preliminary findings in the journal European Urology. The study evaluated the safety and preliminary efficacy of anti-PD-L1 directed therapy with durvalumab (cohort 1), durvalumab plus Bacillus Calmette-Guerin (BCG) (cohort 2) and durvalumab plus external beam radiation therapy (EBRT) (cohort 3).

Hoosier Cancer Research Network investigators will present their findings from the HCRN GU16-260 study during the 2022 American Society of Clinical Oncology Genitourinary Cancer Symposium meeting on Saturday, February 19. Investigators of HCRN GU16-260 will present the abstract titled, Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients with advanced clear cell renal cell (HCRN GU16-260-Cohort A): Final report. Read More

Hoosier Cancer Research Network investigators recently presented an abstract during the 2022 Gastrointestinal Cancers Symposium. The abstract included an online poster session featuring HCRN GI15-225, led by UNC Lineberger Comprehensive Cancer Center. Read More

A Translational Breast Cancer Research Consortium (TBCRC) study was presented at both the 2021 San Antonio Breast Cancer Symposium and the American Society for Radiation Oncology (ASTRO) 2021 Annual meeting. TBCRC044 is led by Hope S. Rugo, MD of the Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco.

The TBCRC044 study, a randomized phase II study of pembrolizumab in combination with carboplatin compared to carboplatin, is a multicenter study including breast cancer patients with chest wall disease that is hormone resistant or triple negative. Read More

Reposted with permission by the Indiana University School of Medicine

Indiana University School of Medicine physician scientist Bryan Schneider, MD is the principal investigator of clinical trial HCRN BRE12-158, a randomized clinical study published in the prominent Journal of Clinical Oncology the primary goal of which was to compare survival in women with high-risk (those who did not fully respond to chemotherapy prior to surgery) triple negative breast cancer (TNBC) with a genomically directed therapy versus standard of care.

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Reposted with permission by the Indiana University School of Medicine.

Indiana University School of Medicine researcher Bryan P. Schneider, MD, is leading a novel nationwide study to better understand how to treat patients with triple-negative breast cancer based on their own unique genetic data.

PERSEVERE, also known as HCRN BRE18-334, is a phase 2 clinical trial with the goal of studying personalized cancer treatment combinations when compared to standard cancer treatment.

“There is a tremendous need for successful triple-negative breast cancer treatments,” said Schneider, who is the Vera Bradley Professor of Oncology at IU School of Medicine and a physician-scientist at the IU Melvin and Bren Simon Comprehensive Cancer Center and the Vera Bradley Foundation Center for Breast Cancer Research. “Recurrence and death rates are still too high, and novel strategies to improve that are markedly needed. We feel PERSEVERE is an innovative trial to try to help meet those needs.” Read More

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

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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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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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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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

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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