Aug. 16, 2019:

Indiana University researchers are leading a new Big Ten Cancer Research Consortium study that will test consolidation immunotherapy in unresectable Stage III non-small cell lung cancer.

The standard treatment for this setting is concurrent chemoradiation. Prior studies have tested the addition of consolidation chemotherapy, targeted therapies, and antiangiogenic therapies. Yet there remains an unmet need.

“We are still looking for ways to move the bar,” said Greg Durm, MD, of the IU Simon Cancer Center and sponsor-investigator of the study.

Immunotherapy, and checkpoint inhibitors in particular, have shown improvements in patients with Stage IV disease. In addition, combinations of immunotherapy drugs have demonstrated greater effectiveness than single-agent immunotherapy in melanoma. “Incorporating these drugs, including immunotherapy combinations, into the consolidation setting for Stage III disease makes sense,” Dr. Durm said.

The new research study, known as BTCRC-LUN16-081, is a randomized phase II study testing consolidation therapy with nivolumab and ipilimumab or nivolumab alone following concurrent chemoradiation in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.

Patients whose disease has responded or remains stable following standard concurrent chemoradiation will be randomized to one of two treatment arms. Patients on Arm 1 will receive nivolumab every 4 weeks for up to 6 cycles. Patients on Arm 2 will receive nivolumab every two weeks plus ipilimumab every 6 weeks for up to 4 cycles.

The study will enroll up to 105 subjects (54 subjects in Arm 1 and 51 subjects in Arm 2).

Nivolumab, also known as OPDIVO®, is an antibody that is being tested to see if it will allow the body’s immune system to work against tumor cells. The immune system sends out special cells called T cells to fight infections and diseases throughout the body. Some cancer cells can hide from T cells by taking control of a pathway called PD-1. This lets the cancer cells avoid an attack from T cells. Nivolumab is an immunotherapy that blocks the PD-1 pathway. By blocking PD-1, it may allow the human immune system to recognize and kill cancer cells. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) to treat lung, skin, kidney, Hodgkin lymphoma, head and neck, bladder, colorectal, and liver cancers.

Ipilimumab, also known as YERVOY®, is also an antibody that is being tested to see if it will allow the body’s immune system to work against tumor cells. Like nivolumab, ipilimumab is an immunotherapy. Ipilimumab blocks a pathway in the immune system called CTLA-4. By blocking CTLA-4, it may help the immune system to recognize and kill cancer cells.

While nivolumab and ipilimumab are both approved by the FDA in certain settings, giving them after completing chemotherapy and radiation treatment should be considered “investigational.” This means using these drugs in this setting has not been approved by the FDA.

The BTCRC-LUN16-081 study is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center; Michigan State University; Penn State Cancer Institute; Rutgers Cancer Institute of New Jersey; University of Illinois Cancer Center; University of Nebraska Medical Center; University of Wisconsin; Masonic Cancer Center, University of Minnesota; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Karmanos Cancer Center, and University of Louisville James Graham Brown Cancer Center.

Funding support for this research study is provided by Bristol-Myers Squibb Company. OPDIVO and YERVOY are trademarks of Bristol-Myers Squibb Company.

For more information about this study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT03285321).

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.