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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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 investigators recently presented an E-Poster on the HCRN study GU18-343 during the ESMO 2020 Virtual Congress.

The multi-center clinical trial, “A Phase 2 Study of Cabozantinib in Combination with Atezolizumab as NeoAdjuvant Treatment for Muscle-Invasive BladdEr Cancer (ABATE),” is led by Deepak Kilari, MD, a medical oncologist and researcher at Froedtert & the Medical College of Wisconsin. The study is now enrolling subjects at the Medical College of Wisconsin. Additional participating institutions will include Hackensack University, the University of North Carolina at Chapel Hill, the University of Rochester, and Vanderbilt University.

The study is a single-arm, open-label clinical trial that is assessing the safety and efficacy of combining cabozantinib and atezolizumab as a neoadjuvant therapy in adult patients with muscle-invasive bladder cancer, with a focus on cisplatin-ineligible patients. Read More

The Hoosier Cancer Research Network study, LUN14-179, “A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab (MK-3475) for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): HCRN LUN14-179,” affirms the effectiveness of consolidation immunotherapy after chemoradiation in adults with unresectable stage IIIA or IIIB non-small cell lung cancer. The study demonstrates that the addition of pembrolizumab in Stage III NSCLC may be associated with prolonged time to metastatic disease or death (TMDD), progression-free survival (PFS) and overall survival (OS), after treatment with chemoradiation. The findings were recently published in the Clinical Lung Cancer journal and American Cancer Society’s Cancer journal. The median TMDD was 30.7 months, the median PFS was 18.7 months, and the median OS was 35.8 months. Read More

A phase II study for adults with extensive-stage small cell lung cancer is testing the hypomethylating agent guadecitabine combined with the platinum-based chemotherapy drug carboplatin. The study is open to accrual at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, Ind.; IU Health Ball Memorial Cancer Center in Muncie, Ind.; and the University of Virginia Cancer Center in Charlottesville, Va.

More than 234,000 new cases of lung and bronchus cancer were estimated for 2018, 10 to 15 percent of which are small cell lung cancer. Small cell lung cancer is often treated with chemotherapy, which could be a platinum-based drug or another form of chemotherapy. However, eventually patients’ cancers stop responding to these drugs.

The HCRN study, LUN17-302, “A Phase II Study Evaluating Efficacy and Safety of Hypomethylating Agent Guadecitabine in Combination with Carboplatin in Extensive Stage Small Cell Lung Cancer,” will help determine whether the combination of guadecitabine with carboplatin is better, the same, or worse than the standard treatment and will evaluate the good and bad effects of this combined therapy. Read More

Investigators participating in Hoosier Cancer Research Network’s Thoracic Clinical Trial Working Group have named three of their colleagues to serve as co-chairs of the group. The new co-chairs are (pictured from left) Greg Durm, MD, assistant professor of clinical medicine at Indiana University School of Medicine and a researcher at the IU Melvin and Bren Simon Comprehensive Cancer Center; Mary Jo Fidler, MD, associate professor, Department of Internal Medicine at Rush Medical College, Rush University; and Ryan Gentzler, MD, associate professor of medicine: hematology and oncology at the University of Virginia School of Medicine. They succeed former co-chairs Karen L. Reckamp, MD, MS, director of the Division of Medical Oncology at Cedars-Sinai Cancer, and Rachel E. Sanborn, MD, medical oncologist at Providence Cancer Institute. HCRN co-chairs serve two-year terms with the potential to serve additional terms with the support of their colleagues. Read More

A Hoosier Cancer Research Network study is testing a treatment combination for patients with gastric or esophageal cancer. The phase II study, HCRN GI17-319, focuses on adult patients whose cancer cannot be removed by surgery or has metastasized, and possess an amplification of the gene known as human epidermal growth factor receptor 2 (HER2).

The study, “A single arm, multi-center Phase 2 trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas,” explores whether adding avelumab, a PD-L1-targeting drug to chemotherapy and trastuzumab, a HER2-targeted therapy, will control a patient’s cancer for a longer period compared to the current standard treatment. It will also test the safety and tolerability of this combined therapy. Read More

Researchers at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center are leading a multi-site phase II study through the Hoosier Cancer Research Network for previously treated metastatic esophageal cancer patients with specific genetic mutations. The study is now open to accrual at the IU Simon Cancer Center, Moffitt Cancer Center, and Roswell Park Cancer Institute.

The study, HCRN ESO17-325, “A Phase II Study Evaluating Safety and Efficacy of Niraparib in Patients with Previously Treated Homologous Recombination Defective or Loss of Heterozygosity high Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma,” will test the effectiveness of using the PARP inhibitor, niraparib, versus the current standard of care, in treating patients with one of three genetic mutations, including homologous recombination (HR) mutation in tumor tissue; high rate of loss of heterozygosity (LOH) in tumor tissue; or a germline mutation in the blood. The study uses precision medicine by applying patients’ genetic information to guide treatment decisions. Read More

Results from a multi-site clinical trial for patients with triple-negative breast cancer (TNBC) show that genomic testing for circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) after neoadjuvant chemotherapy can be used to detect residual disease and identify which patients could be at high risk of relapse. The results were recently published in JAMA Oncology.

The preplanned secondary analysis was conducted from March 26, 2014, to December 18, 2018, using data from 196 female patients in BRE12-158, a phase 2 multicenter randomized clinical trial that randomized patients with early-stage TNBC who had residual disease after neoadjuvant chemotherapy to receive post-neoadjuvant genomically directed therapy vs. treatment of physician choice. The study was led by the Indiana University School of Medicine and managed by Hoosier Cancer Research Network. Read More

A Hoosier Cancer Research Network study for patients with high-risk ocular melanoma, a rare type of cancer affecting the eye, is now open for accrual. According to the National Cancer Institute, ocular melanoma often doesn’t present early signs or symptoms.

Typically, patients with ocular melanoma can choose to have surgery to remove the eye, called enucleation, or receive radiation to the eye. After either treatment, patients are monitored for recurrence of their disease. Patients with high-risk ocular melanoma have a risk of cancer recurrence of up to 50% within 3 years after receiving initial treatment for their disease.

A number of treatment options are now available for patients with cutaneous melanoma, which begins in skin cells called melanocytes, the pigment-producing cells that generate pigments of our skin, hair, and eyes. However, progress in treating high-risk ocular melanoma has eluded researchers. Read More

The American Society of Clinical Oncology’s ASCO20 Virtual Scientific Program will feature abstracts from three Hoosier Cancer Research Network studies. The program, taking place May 29-31, will feature more than 250 oral abstract presentations and 2,500 poster presentations from 24 disease-based and specialty tracks.

The abstracts featuring HCRN studies include an oral abstract for GU16-260, a poster discussion for GU14-188, and posters for GU14-188 and LUN14-179. Read More

A Hoosier Cancer Research Network study for adult patients with muscle-invasive bladder cancer (MIBC) will help doctors determine whether some patients could forego bladder removal and receive standard chemotherapy drugs and the immunotherapy drug, nivolumab. It will also test whether adding nivolumab to chemotherapy drugs, gemcitabine and cisplatin, works better than chemotherapy alone for treating bladder cancer that has invaded the muscle layer of the bladder. Correlative tests, including genomic sequencing, will play a critical role in identifying biomarkers that might help determine which patients could be spared the removal of their bladders.

People with MIBC are typically treated with chemotherapy and a radical cystectomy, or surgical removal of the bladder. Chemotherapy preceding surgery has been shown to increase the likelihood of curing bladder cancer compared to surgery alone.

The phase II study, “Neoadjuvant gemcitabine, cisplatin, plus nivolumab in patients with muscle-invasive bladder cancer with selective bladder sparing,” also known as HCRN GU16-257, is now enrolling eligible subjects, ages 18 and above, at Tisch Cancer Institute at Mount Sinai in New York, NY; City of Hope in Duarte, Calif.; Huntsman Cancer Institute in Salt Lake City, Utah; Oregon Health and Science University in Portland, Ore.; Penn Medicine Abramson Cancer Center in Philadelphia, Pa.; University of Wisconsin Carbone Cancer Center in Madison, Wis.; and USC Norris Comprehensive Cancer Center in Los Angeles, Calif. Up to 76 subjects will participate in the study. Read More

In a phase II study reported in the Journal of Clinical Oncology, Hoosier Cancer Research Network (HCRN) investigators report that switch maintenance pembrolizumab leads to additional objective responses and significantly prolongs progression-free survival in patients with metastatic urothelial cancer achieving at least stable disease with first-line platinum-based chemotherapy.

The multi-center investigator-initiated study, “A Randomized, Double-Blinded, Phase II Study of Maintenance Pembrolizumab versus Placebo after First-line Chemotherapy in Patients with Metastatic Urothelial Cancer: HCRN GU14-182,” was led by the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, and included 30 member sites of HCRN. Read More

A Hoosier Cancer Research Network multi-site phase II study led by Icahn School of Medicine at Mount Sinai/Tisch Cancer Institute is testing the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib in metastatic urothelial cancer patients with somatic DNA damage response (DDR) alterations in their cells. The study is open to accrual at HCRN member sites, including: Barbara Ann Karmanos Cancer Center in Detroit, Mich.; Huntsman Cancer Institute in Salt Lake City, Utah; Icahn School of Medicine at Mount Sinai in New York, N.Y.; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Md.; The University of Chicago Medicine Comprehensive Cancer Center in Chicago, Ill; and the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Urothelial cancer forms in cells that line the urethra, bladder, renal pelvis, and ureters. Bladder tumors often have mutations in genes involved in repair of DNA damage.

“We know in urothelial cancer that, based on genomic sequence studies that have been done, a lot of mutations occur in these DNA damage repair genes, but it has never really been tested whether or not these gene mutations in bladder cancer render tumors more susceptible to these drugs called PARP inhibitors,” said Matthew D. Galksy, MD, sponsor-investigator of the study and a medical oncologist at Mount Sinai. Read More

Indiana University Melvin and Bren Simon Cancer Center is leading a phase II clinical trial that will test the PD-L1 checkpoint inhibitor atezolizumab plus chemotherapy in patients with advanced urothelial cancer who are cisplatin-ineligible and whose cancer worsened after treatment with a PD-1 or PD-L1 inhibitor.

The study, HCRN-GU17-295, is open to accrual at the IU Simon Cancer Center in Indianapolis and Methodist Hospital in Omaha, Neb. Read More

Hoosier Cancer Research Network investigators presented a trials in progress poster featuring the HCRN study GU17-295 during the American Society of Clinical Oncology’s 2020 Genitourinary Cancers Symposium on Friday, Feb. 14, in San Francisco, Calif.

The poster, titled, “Phase II trial of atezolizumab plus chemotherapy after progression on single-agent PD-1 or PD-L1 inhibitor in cisplatin ineligible patients with advanced urothelial carcinoma HCRN GU17-295,” was presented during Trials in Progress Poster Session B: Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers. See abstract.

“This phase two study aims to investigate continuation of immunotherapy beyond progression and the addition of chemotherapy in patients with cisplatin-ineligible metastatic urothelial carcinoma,” said Nabil Adra, MD, MSc, sponsor-investigator of the study and a researcher at the Indiana University Melvin and Bren Simon Cancer Center. “If successful, we would like to investigate the mechanism of re-sensitizing tumors to immunotherapy with the addition of chemotherapy.” Read More

The Hoosier Cancer Research Network study, HCRN ESO17-325, a phase II study for adults with previously treated metastatic esophageal cancer, with one of three genetic mutations, including homologous recombination (HR) in tumor tissue; defective or loss of heterozygosity (LOH) in tumor tissue; or a germline mutation in the blood, was featured as a trials in progress poster during the American Society of Clinical Oncology‘s 2020 Gastrointestinal Cancers Symposium on Jan. 23, 2020. The study, which is open to accrual at Indiana University Melvin and Bren Simon Cancer Center and Moffitt Cancer Center, tests the safety and efficacy of the PARP inhibitor, niraparib, versus the current standard of care. Read More

Indiana University School of Medicine researchers have discovered how to predict whether triple negative breast cancer will recur, and which women are likely to remain disease-free. They presented their findings on December 13, 2019, at the San Antonio Breast Cancer Symposium, the most influential gathering of breast cancer researchers and physicians in the world.

Milan Radovich, PhD (pictured left), and Bryan Schneider, MD, discovered that women whose plasma contained genetic material from a tumor – referred to as circulating tumor DNA – had only a 56 percent chance of being cancer-free two years following chemotherapy and surgery. Patients who did not have circulating tumor DNA, or ctDNA, in their plasma had an 81 percent chance that the cancer would not return after the same amount of time. Read More

Hoosier Cancer Research Network investigators highlighted an HCRN melanoma study as a poster presentation during the Society for Melanoma Research 16th International Congress, Nov. 20-23, 2019, in Salt Lake City, Utah.

The authors, led by sponsor-investigator Suthee Rapisuwon, MD (pictured left), and co-investigator Michael B. Atkins, MD, both of Georgetown University Lombardi Comprehensive Cancer Center, presented the MEL17-309 study, in a poster titled “Phase II single-arm multi-center study of adjuvant ipilimumab in combination with nivolumab in subjects with high-risk ocular melanoma.” (See abstract.)

The primary endpoint of the MEL17-309 study is 3-year relapse-free survival rate. Secondary endpoints are median relapse-free survival, median overall survival, 3-year overall survival rate, and safety. Read More

A single arm, phase II clinical trial for patients with metastatic renal cell carcinoma (RCC), the most common type of kidney cancer, is testing the histone deacetylase (HDAC) inhibitor entinostat in combination with ipilimumab and nivolumab in patients previously treated with nivolumab and ipilimumab or nivolumab alone. The study is open to accrual at Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, Ind., and Georgetown University in Washington, D.C.

The study, HCRN-GU17-326, will test the safety and efficacy of this combination. Researchers will estimate the percentage of patients whose tumors shrink during the study, and how long it takes before their tumors start growing again.

Roberto Pili, MD, a professor of oncology at the Indiana University School of Medicine and a researcher at the IU Simon Cancer Center, is sponsor-investigator of the study. Dr. Pili said the combination of entinostat with nivolumab and ipilimumab has demonstrated significant activity for patients with RCC in early studies. Read More