Aug. 16, 2019:

A new Big Ten Cancer Research Consortium study will test the efficacy and safety of combining abemaciclib and pembrolizumab in patients with unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, who are still fighting their cancers after prior treatment. The single arm, phase II study will be led by the University of Wisconsin Carbone Cancer Center in Madison, Wis.

Current treatment for patients with unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma involves chemotherapy in earlier lines, but despite aggressive treatments, survival remains poor. New combination strategies are being tested to determine whether patient outcomes can improve.

All Big Ten CRC studies involve mentorship between junior and senior investigators. In this study, junior investigator Nataliya V. Uboha, MD, PhD, of the University of Wisconsin, and senior mentor Howard Hochster, MD, of Rutgers Cancer Institute of New Jersey, are leading the multi-institutional collaboration of Big Ten cancer centers.

According to Dr. Uboha, sponsor-investigator of the trial, and an oncologist specializing in gastrointestinal malignancies at the University of Wisconsin, treatment in the third line of therapy is limited.

“In third line setting, which is where we will be conducting this trial, the only standard of care is pembrolizumab and it is only for patients who have a PD-L1 expression,” said Dr. Uboha. “So that’s only about 40% of patients. For all others, the other 60% of patients whose tumors don’t have a PD-L1 expression, there really is no standard of care. And frequently these patients are either given another chemotherapy that may or may not work or they are referred to hospice.”

Dr. Uboha said the new study, known as BTCRC-GI18-149, is designed for patients who have received two prior lines of therapy for their disease, who have not been treated with immunotherapy and who are still candidates for additional treatments.

Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor of CDK4 and CDK6, which slows down cancer cell growth and division. This drug has been approved by the U.S. Food & Drug Administration (FDA) to certain types of breast cancer in adults.

Pembrolizumab is a monoclonal antibody that blocks a programmed cell death 1 (PD-1) receptor that may be used by cancer cells to hide from the body’s immune system. By blocking this receptor, pembrolizumab helps the body’s immune system to recognize and fight cancer cells. Pembrolizumab is approved by the FDA to treat several types of cancer.

The combination of abemaciclib and pembrolizumab is not approved for treating metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, and should be considered investigational.

The BTCRC-GI18-149 study is now open to accrual at the University of Wisconsin and will expand to other Big Ten cancer centers. Adults ages 18 and older with unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, who have who have received at least two lines of prior therapies for advanced disease, may be eligible to participate in the study. Up to 34 subjects will be accepted into this study.

Participants will be administered treatment in 21-day cycles. Pembrolizumab will be given intravenously (IV) and abemaciclib will be taken orally. Subjects will continue treatment until their disease worsens, they experience too many side effects, or they decide to discontinue treatment.

The study will also involve the collection of blood, tissue, and saliva samples. These samples will be used to study why some tumors are more sensitive to the treatment than others. Samples will also be banked for future studies as well.

Eli Lilly and Company will support the study, which is anticipated to last up to two years.

For more information about this research study, including full eligibility requirements, visit (study #NCT03997448).

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