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HCRN Research

HCRN study highlighted at international melanoma meeting

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

Study tests entinostat in combination with ipilimumab and nivolumab in metastatic RCC

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

HCRN studies presented at 2019 World Conference on Lung Cancer

Investigators reported results from two HCRN studies during poster sessions at the 2019 World Conference on Lung Cancer, September 7-9 in Barcelona, Spain.

Study authors, led by Greg Durm, MD (pictured left), of the Indiana University Melvin and Bren Simon Cancer Center, reported results of the LUN14-179 study, in a poster titled “ChemoXRT w/ Consolidation Pembrolizumab in Unresectable Stage III NSCLC: Long-Term Survival Update and Analysis of Post-Progression Therapy.” (See abstract.)

LUN13-175 study authors, led by Ryan Gentzler, MD, of the University of Virginia, presented a poster titled “Ph I/II Carboplatin, Nab-Paclitaxel and Pembrolizumab for Advanced NSCLC (HCRN LUN13-175): Outcomes by Nab-Paclitaxel Dose.” (See abstract.) Read More

Study compares high-dose IL-2 and HDAC inhibitor entinostat to IL-2 alone

A phase II, open label study for patients with renal cell carcinoma (RCC), the most common type of kidney cancer, is currently enrolling subjects at selected Hoosier Cancer Research Network sites. The HCRN GU17-289 study, led by researchers at the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis, Ind., compares the positive and negative effects of using high-dose interleukin-2 (IL-2) and entinostat to using IL-2 alone. The study also assesses the safety and tolerability of IL-2 and entinostat.

IL-2, also known as aldesleukin, is a biological response modifier that boosts the immune system in cancer treatment and is made in a laboratory setting. The human body also produces IL-2, which is a protein that enhances the growth of cells to build the body’s immune system.

Entinostat is an investigational Class I selective histone deacetylase (HDAC) inhibitor that plays a vital role in regulating gene expression and inducing cell death, known as apoptosis, in cancer cells. Read More

Study tests atezolizumab with bevacizumab in advanced bladder cancer

Each year in the United States, more than 70,000 patients are diagnosed with bladder cancer, and more than 14,000 will die from their disease. The current standard for treating bladder cancer involves chemotherapy, but this approach is not adequate for many patients, particularly those whose disease has metastasized, or spread to other parts of the body.

A new Hoosier Cancer Research Network study may help researchers determine whether a novel approach involving a combination of immunotherapy drugs might benefit patients with advanced disease who are not eligible to receive cisplatin-based chemotherapy.

[Arjun Balar, MD (pictured), of the New York University Langone Medical Center, is sponsor-investigator of the HCRN GU15-215 study.]

The single-arm phase II study, known as HCRN GU15-215, involves the anti-PD-L1 antibody atezolizumab with bevacizumab, a VEGF-targeting antibody that may help to prevent the growth of new blood vessels that feed tumors. Bevacizumab may act in combination with atezolizumab to enhance the anti-tumor immune response. Read More

ASCO selects HCRN studies for oral abstract and poster sessions

Two Hoosier Cancer Research Network studies, GU14-182 and MEL17-309, will be presented during the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 – June 4, in Chicago.

HCRN GU14-182, a randomized, double-blinded, phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer, will be featured during an oral abstract session on Monday, June 3. The multi-center study is led by Matthew Galsky, MD, of the Icahn School of Medicine at Mount Sinai.

Session Details: Read More

GU14-188 abstract presented at AUA 2019 annual meeting

The Hoosier Cancer Research Network study HCRN GU14-188, a multicenter Phase Ib/II study of neoadjuvant pembrolizumab and cisplatin chemotherapy for muscle-invasive urothelial cancer, was featured as a podium session abstract May 5, 2019, during the American Urological Association (AUA) Annual Meeting in Chicago. The multi-center study is led by sponsor-investigator Christopher Hoimes, DO (pictured), of the Case Comprehensive Cancer Center at University Hospitals-Seidman Cancer Center. The abstract was presented by Hristos Kaimakliotis, MD, of the Indiana University School of Medicine.

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GI14-198 study presented at GI ASCO 2019

The Hoosier Cancer Research Network study HCRN GI14-198, a Phase II randomized, double-blind, study of mfolfirinox plus ramucirumab versus mfolfirinox plus placebo in advanced pancreatic cancer patients, was featured as a trials in progress poster during the 2019 Gastrointestinal Cancers Symposium, Jan. 18 in San Francisco, CA. The multi-center study is led by sponsor-investigator Walid Shaib, MD, of the Winship Cancer Institute of Emory University.

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Mesothelioma study tests combination of antiangiogenic therapy and immunotherapy

A single arm phase II study, LUN15-299, for patients who have been previously treated for mesothelioma is being conducted by the Hoosier Cancer Research Network and led by HealthPartners Regions Cancer Care in St. Paul, Minn.

The clinical trial will test how the addition of an antiangiogenic therapy drug, ramucirumab, will work with nivolumab, an immunotherapy drug. Researchers hope the combined therapy will help keep the cancer under control. Read More

ADAPT-BLADDER study compares novel immunotherapy combinations and BCG re-treatment in non-muscle invasive bladder cancer

Hoosier Cancer Research Network (HCRN) has opened a study for patients with non-muscle invasive bladder cancer who were previously treated with the Bacillus Calmette-Guerin (BCG) vaccine. The randomized phase I/II clinical trial will test standard re-treatment with BCG against the immunotherapeutic agent durvalumab combined with BCG, or durvalumab combined with radiation therapy. Read More

Hoimes presents GU14-188 study at ESMO

Christopher J. Hoimes, DO, presented the Hoosier Cancer Research Network study GU14-188 at a poster discussion session October 20 during the 2018 European Society of Medical Oncology (ESMO) Congress in Munich, Germany. Dr. Hoimes is sponsor-investigator of the study of neoadjuvant pembrolizumab and chemotherapy for locally advanced urothelial cancer.

See the HCRN GU14-188 poster and read the abstract here.

See coverage in UroToday:

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HCRN study explores investigational vaccine therapy for metastatic colorectal cancer

Rutgers Cancer Institute of New Jersey is offering a Hoosier Cancer Research Network clinical trial (HCRN GI16-288) targeting an advanced form of colorectal cancer with a combination vaccine/immunotherapy treatment.

The standard way of treating colorectal cancer that has spread to the liver or has recurred is with a combination of chemotherapy and removal of the cancer through surgery. This approach, however, is not always effective, as the majority of patients suffer a recurrence of their cancer following standard treatment, emphasizing the need for new therapies that can prevent the cancer from coming back. Researchers at Rutgers Cancer Institute are exploring the combination of a new anti-cancer vaccine with an immunotherapy, nivolumab, to determine if the combined treatment can prompt a patient’s natural defenses (the immune system) to attack their cancer. Investigators also will determine if the vaccine/immunotherapy combination works better than immunotherapy plus chemotherapy and surgery.
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New study compares chemotherapy options with nivolumab in cisplatin-ineligible metastatic bladder cancer

A new Hoosier Cancer Research Network study may help researchers determine whether the choice of chemotherapy regimens used in combination with the immunotherapy drug nivolumab could make a difference in outcomes for patients with metastatic bladder cancer.

Standard treatment for metastatic bladder cancer, also known as urothelial carcinoma, usually involves cisplatin-based chemotherapy. However, a large proportion of patients are not eligible for this treatment due to impaired renal function and other physical or age-related limitations. Standard options for these cisplatin-ineligible patients often include carboplatin-based therapies.

Recent studies have shown that single-agent immunotherapy drugs that target the programmed death-1 (PD-1) / programmed death-ligand 1 (PD-L1) pathway as first-line treatment can benefit these patients. However, only about 20 to 25 percent of patients respond to single-agent PD-1/PD-L1 inhibitors. Researchers are now testing whether adding chemotherapy regimens to PD-1/PD-L1 therapy might lead to improved response rates. Read More

Junior IU oncologist presents oral abstract at world’s leading oncology group

Story provided courtesy of IU Simon Cancer Center.

Less than two years ago, Greg Durm, MD, was finishing up his hematology-oncology fellowship at IU School of Medicine. Now he has delivered an oral presentation at the world’s leading organization for oncology professionals.

Dr. Durm presented an oral abstract about a Phase II lung cancer clinical trial Monday, June 4 in Chicago at the annual meeting of the American Society of Clinical Oncology (ASCO). Nearly 40,000 physicians, researchers, and others from around the world attended the meeting.

Read More

LUN14-179 accepted as ASCO oral presentation

Hoosier Cancer Research Network’s LUN14-179 study was accepted as an oral presentation to the American Society of Clinical Oncology (ASCO) Annual Meeting, June 1-5, 2018, at the McCormick Place in Chicago. Read More

Award advances retrospective analysis of HCRN LUN14-179

Investigators working on the HCRN LUN14-179 study, which involved the use of concurrent chemoradiation with consolidation pembrolizumab for unresectable stage III non-small cell lung cancer, anticipated that some patients would experience pneumonitis. But they did not know which of their patients might be more susceptible than others.

To learn more about the rates of pneumonitis among study participants, and whether biomarkers could be identified that might predict whether a patient might be more susceptible, researchers at the Indiana University Melvin and Bren Simon Cancer Center launched a retrospective analysis of the study data. Read More

Researchers test combination immunotherapy in mucosal melanoma

Mucosal melanoma is a rare form of cancer, constituting about 1 percent of all melanoma cases. The disease arises from the pigment-producing melanocytes present in the body’s mucosal tissue, and is most commonly found in the head and neck region, anorectal region, and female genital tract.

Unlike the far more common cutaneous melanomas, mucosal melanomas are not widely studied, and no accepted standard of care has been established. Recurrence rates, even for early-stage disease, approach 100 percent, underscoring the urgent need for effective therapies for this population.

A new study led by Robert R. McWilliams, MD, of Mayo Clinic, in collaboration with the Midwest Melanoma Partnership (MMP) and Hoosier Cancer Research Network (HCRN), may provide valuable knowledge toward better understanding this disease. Read More

Caris Life Sciences selected to perform genomic profiling for UC-GENOME study

The Bladder Cancer Genomics Consortium (BCGC) and Hoosier Cancer Research Network today announced the selection of Caris Life Sciences® to perform genomic profiling for UC-GENOME, a large-scale genomically driven bladder cancer study.

The study, also known as HCRN GU15-217, is the first project of the BCGC, a collaborative effort between the Bladder Cancer Advocacy Network and major medical centers recognized for their expertise in bladder cancer. Bladder cancer is the sixth most commonly diagnosed cancer in the U.S., with more than 79,000 new cases and 16,800 deaths estimated in 2017. Read More

Genomic analysis and biorepository research study takes aim at metastatic bladder cancer

Hoosier Cancer Research Network is partnering with the Bladder Cancer Advocacy Network (BCAN) to conduct a large-scale bladder cancer genomic analysis and biorepository research study.

Known as UC-GENOME (HCRN GU15-217), the research study is the first project of the Bladder Cancer Genomics Consortium (BCGC), a collaborative effort between BCAN and major medical centers. The BCGC’s goal is to develop an enriched understanding of the genomic profile of bladder cancer to facilitate the development of novel therapeutics.

The research study is open to accrual at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, N.C. Additional sites are expected to open soon. Read More

HCRN study tests mFOLFIRINOX combined with ramucirumab in advanced pancreatic cancer

Researchers investigating many types of cancers have celebrated significant breakthroughs over the years. Yet, some cancers lag well behind these successes.

Pancreatic cancer remains one of the most difficult to treat cancers. In 2016, about 53,000 new pancreatic cancer cases were diagnosed in the United States, and nearly 42,000 people died of their disease. Despite these statistics, there are glimmers of hope on the horizon.

Recent studies have shown that certain combination therapies can lead to improved outcomes over single agent therapy in pancreatic cancer. For example, a study of FOLFIRINOX (a combination of the drugs fluorouracil (5-FU), irinotecan, oxaliplatin, and leucovorin) was shown to improve one-year survival compared to gemcitabine alone.

As immunotherapies have gained prominence, pancreatic cancer researchers are now looking to take combination therapies to a new level. Read More

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