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HCRN Research

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

New study tests atezolizumab with or without 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 randomized phase II study, known as HCRN GU15-215, involves the anti-PD-L1 antibody atezolizumab with or without 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

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

Study tests combination immunotherapy in advanced bile duct cancer

Cholangiocarcinoma, also known as bile duct cancer, is steadily rising in incidence worldwide. Symptoms often go undetected until the disease is far advanced. Surgical resection of tumors is considered the best approach toward attempting a cure, but less than half of patients whose tumors are surgically resected survive past five years, and those whose tumors are not surgically removed face a median survival time of just nine months.

A new Hoosier Cancer Research Network study may help researchers learn whether an investigational combination of immunotherapy drugs might lead to improvements in tumor response in cholangiocarcinoma patients who have received prior therapy for their cancer.

The study, known as HCRN GI16-263, is now open to accrual at the Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C. Additional sites will open the study in the near future.

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Study tests nivolumab, ipilimumab in treatment-naive kidney cancer

Hoosier Cancer Research Network (HCRN) announces the opening of a study for patients with advanced renal cell carcinoma who have not received prior treatment for their kidney cancer.

The phase II clinical trial, known as HCRN GU16-260, involves front-line therapy with nivolumab and salvage therapy with nivolumab and ipilimumab. The study may help researchers determine the activity of nivolumab, an agent already approved for patients with previously treated kidney cancer, in patients who have not received prior treatment.

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HCRN study compares sequence of immunotherapy and anti-angiogenic drugs in metastatic kidney cancer

A new Hoosier Cancer Research Network study may help researchers learn whether the order in which two drugs are given has any effect on progression-free survival — the length of time it takes for cancer to grow or spread.

The randomized phase II study, known as HCRN GU15-223, will compare overall progression-free survival for two groups of subjects with metastatic renal cell carcinoma (kidney cancer). One group will receive first-line sunitinib, an anti-angiogenic drug, followed by second-line avelumab, an investigational immunotherapy drug. The other group will receive first-line avelumab followed by second-line sunitinib. Patients will have an equal chance of being randomized to either group.

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Three HCRN studies accepted to ASCO 2017

Abstracts from three Hoosier Cancer Research Network studies were accepted to the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting, June 2-6 at the McCormick Place in Chicago. The studies include LUN14-179 (poster session and discussion), GU14-206 (poster session and discussion), and GI14-186 (poster session). Read More

Study tests safety, efficacy of pembrolizumab and Y90 in locally advanced hepatocellular carcinoma

Hepatocellular carcinoma is an aggressive cancer that is often difficult to treat due to the typical accompanying diagnosis of cirrhosis. For patients who qualify for curative treatment, surgery and liver transplant may be considered. However, most patients are not eligible for curative therapy, and instead may be offered liver-directed or systemic therapies that may extend overall survival, but outcomes remain poor for these patients.

A new Hoosier Cancer Research Network study led by researchers at the University of North Carolina at Chapel Hill will help determine whether adding an immunotherapy drug to standard local radiation therapy for patients with high-risk hepatocellular carcinoma could lead to further improvements in overall survival.

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Results from three HCRN studies presented at GU ASCO

Three Hoosier Cancer Research Network studies were featured in poster sessions during the 2017 Gastrointestinal Cancers Symposium, Feb. 16-18 in Orlando.

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Study compares docetaxel with or without nivolumab in advanced non-small cell lung cancer

A new study led by researchers at the Indiana University Melvin and Bren Simon Cancer Center may help answer questions about the role of immunotherapy in combination with chemotherapy in treating lung cancer patients whose disease worsened after initial response to immunotherapy.

The randomized phase II study, known as HCRN LUN15-233, involves docetaxel (also known as Taxotere®) with or without nivolumab (also known as Opdivo®).

The study is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center. Additional sites will open the study in the near future. Nasser Hanna, MD, (pictured) is leading the study, along with co-investigators Laura Lourdes, MD; Shadia Jalal, MD; and Lawrence Einhorn, MD. Read More

OncoGenex announces positive survival results for GU12-160 study

OncoGenex Pharmaceuticals, Inc. has announced positive survival results from the final analysis of the Phase 2 Borealis-2™ trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. The trial, also known as HCRN GU12-160, was conducted by the Hoosier Cancer Research Network at 28 sites across the United States.

Patients who received apatorsen treatment experienced a 20 percent reduction in risk of death, compared to patients receiving docetaxel alone (HR=.80; 80% CI: 0.65-0.98; p=0.078). The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.

Read more at oncogenex.com. Read More

HCRN study tests efficacy of supportive therapy with ginseng for patients receiving regorafenib

A new Hoosier Cancer Research Network study is evaluating whether ginseng can help lessen fatigue in patients treated with regorafenib.

The study, known as GI14-191, builds on earlier research that showed daily use of American ginseng significantly decreased the level of fatigue experienced by cancer patients undergoing treatment. GI14-191 focuses on patients receiving regorafenib for colorectal cancer. The study is currently open to accrual at Wake Forest Baptist Health in Winston-Salem, N.C., with additional sites expected to open in the near future. Read More

HCRN study combines bone-targeting drug with androgen deprivation therapy for metastatic prostate cancer

Hoosier Cancer Research Network (HCRN) announces the launch of a cancer clinical trial for subjects with newly diagnosed metastatic prostate cancer with bone metastases.

The study, known as GU13-170, will compare the good and bad effects of adding Radium-223 dichloride, a bone-targeted drug, to androgen deprivation therapy, the usual treatment for this type of cancer.

The study is now open to accrual at the University of Michigan Comprehensive Cancer Center. Subjects who enroll on this study will be randomized by chance to one of two groups. The first group, called Arm A, will receive androgen deprivation therapy with bicalutamide. This is the usual treatment. The second group, called Arm B, will receive androgen deprivation therapy with bicalutamide plus the study drug, Radium-223 dichloride. Read More

New study evaluates efficacy of immunotherapy drug in treatment of incurable germ cell tumors

Hoosier Cancer Research Network (HCRN) recently launched a cancer clinical trial evaluating the efficacy of the PDL-1 inhibiting drug pembrolizumab in the treatment of patients with incurable platinum refractory germ cell tumors.

The study, known as HCRN GU14-206, is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center. This is a single arm study in which all subjects will receive the study drug, pembrolizumab.

Men and women age 18 and older who have incurable platinum refractory germ cell tumors (testicular or ovarian) may be eligible for this study. Other criteria must be met to fulfill eligibility requirements. Read More

Four HCRN studies accepted to ASCO 2016

Abstracts from four Hoosier Cancer Research Network studies were accepted to the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, June 3-7 at the McCormick Place in Chicago. The studies include GU12-157 (poster session), GU14-188 (poster session), GU14-202 (poster session), and LUN14-179 (publication-only abstract). Read More

HCRN opens clinical trial for subjects with metastatic castrate-resistant prostate cancer

Hoosier Cancer Research Network is pleased to announce the opening of a cancer clinical trial for subjects with metastatic castrate-resistant prostate cancer at select sites throughout the United States.

The study, known as GU14-202, is designed to assess the safety and toxicity of an investigational drug called niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, given in combination with an anti-androgen drug called enzalutamide. The FDA approved enzalutamide for the treatment of castrate-resistant prostate cancer in 2012, but it has not yet approved niraparib.

PARP is a group of proteins that are involved with DNA repair. According to study co-investigator John Paul Flores, MD, of Tufts Medical Center, castrate-resistant prostate cancer often involves defects in DNA repair. Read More

HCRN study compares pembrolizumab to placebo as “maintenance” therapy in metastatic bladder cancer

A new Hoosier Cancer Research Network study is exploring the effects of pembrolizumab in treating metastatic urothelial cancer. The study, known as GU14-182, will compare maintenance pembrolizumab to a placebo in subjects after first-line chemotherapy for metastatic urothelial cancer (e.g., cancer of the bladder, urethra, ureter, or renal pelvis).

The study is currently open to accrual at the Tisch Cancer Institute at Mount Sinai.

The standard approach to treating metastatic urothelial cancer is chemotherapy administered for about 4-6 cycles. If the disease has stabilized or responded, treatment is usually stopped and patients are monitored until their cancer starts to grow again. This is the standard approach because continuing additional standard chemotherapy usually leads to an increase in side effects without necessarily improving the results achieved with chemotherapy. GU14-182 will test whether or not this “stop and wait” approach can be improved by administering pembrolizumab following chemotherapy, according to the study’s sponsor investigator, Matthew Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai. Read More

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