October 9, 2020:

Big Ten Cancer Research Consortium investigators recently presented an E-Poster on the BTCRC-GU16-043 study during the ESMO 2020 Virtual Congress.

The clinical trial is investigating whether adding guadecitabine, a drug that targets DNA methylation, might increase the proportion of patients with advanced clear cell renal cell carcinoma (ccRCC) who respond to treatment with durvalumab, a checkpoint-inhibitor drug that targets the PD-1/PD-L1 pathway.

“In the past decade, checkpoint inhibitors have been a valuable addition to the therapeutic armamentarium of kidney cancer. However, not all patients benefit from this therapy, and there is an unmet need to further improve the clinical outcomes with novel combination strategies,” said co-author Rohan Garje, MD, a genitourinary medical oncologist and researcher at the University of Iowa Carver College of Medicine and Holden Comprehensive Cancer Center. “Preclinical studies have shown the synergy of hypomethylating agents and checkpoint inhibitors in enhancing anti-tumor efficacy. To evaluate this hypothesis, the ambitious collaboration of Big Ten Cancer Research Consortium members led to the development of this study. The preliminary safety results were presented at ESMO Virtual Congress 2020.”

See abstract.

Of the initial six patients enrolled in the study, the combination therapy was deemed safe with acceptable toxicity and promising anti-tumor efficacy. Guadecitabine at the dose of 45 mg/m2 SC daily for 5 days along with the standard dose of durvalumab (1500 mg, IV every 4 weeks on Day 8) was deemed safe for further evaluation.

The study authors include:

  • Yousef Zakharia, MD – University of Iowa
  • Yilun Sun, PhD – University of Michigan
  • Rohan Garje, MBBS – University of Iowa
  • Eric A. Singer, MD, MA, MS, FACS – Rutgers University
  • Monika D. Joshi, MD, MRCP – Penn State University
  • David J. Peace, MD – University of Illinois at Chicago
  • Ajjai S. Alva, MBBS – University of Michigan

The phase II portion of the study is ongoing and additional results, along with biomarker correlatives, will be presented at future scientific meetings.

For more information on this clinical trial, including full eligibility requirements, visit clinicaltrials.gov (study #NCT03308396).


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 more than 9,800 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.