May 29, 2024

A Big Ten Cancer Research Consortium (Big Ten CRC) study was published in Nature Communications on February 1, 2024. The article is titled, “Durvalumab and guadecitabine in advanced clear cell renal cell carcinoma: results from the phase Ib/II study BTCRC-GU16-043.”

According to co-author Dr. Yousef Zakharia of the University of Iowa, “This [study] is an example of the importance of collaboration through networks and consortia, in this case the Big Ten Cancer Consortium. This study was running in the middle of the COVID-19 pandemic when a lot of hospitals shut down their research operations. But due to multicenter collaboration, we were able to get it to the finish line.”

The Big Ten CRC congratulates the investigators of BTCRC-GU16-043 on their publication.


Epigenetic modulation is well established in hematologic malignancies but to a lesser degree in solid tumors. Here we report the results of a phase Ib/II study of guadecitabine and durvalumab in advanced clear cell renal cell carcinoma (ccRCC; NCT03308396). Patients received guadecitabine (starting at 60 mg/m2 subcutaneously on days 1-5 with de-escalation to 45 mg/m2 in case of dose limiting toxicity) with durvalumab (1500 mg intravenously on day 8).

The study enrolled 57 patients, 6 in phase Ib with safety being the primary objective and 51in phase II, comprising 2 cohorts: 36 patients in Cohort 1 were treatment naive to checkpoint inhibitors (CPI) with 0-1 prior therapies and 15 patients in Cohort 2 were treated with up to two prior systemic therapies including one CPI.

The combination of guadecitabine 45 mg/m2 with durvalumab 1500 mg was deemed safe. The primary objective of overall response rate (ORR) in cohort 1 was 22%. Sixteen patients (44%) experienced stable disease (SD). Secondary objectives included overall survival (OS), duration of response, progression-free survival (PFS), clinical benefit rate, and safety as well as ORR for Cohort 2. Median PFS for cohort 1 and cohort 2 were 14.26 and 3.91 months respectively. Median OS was not reached. In cohort 2, one patient achieved a partial response and 60% achieved SD. Asymptomatic neutropenia was the most common adverse event. Even though the trial did not meet the primary objective in cohort 1, the tolerability and PFS signal in CPI naive patients are worth further investigation.

Read the full article.


Yousef Zakharia (University of Iowa Holden Comprehensive Cancer Center), Eric A. Singer of (The Ohio State University)(Rutgers University), Satwik Acharyya (University of Michigan), Rohan Garje (University of Iowa), Monika Joshi (Penn State University), David Peace (University of Illinois at Chicago), Veera Baladandayuthapani (University of Michigan), Xiong Li (University of Michigan), Claudia Lalancette (BRCF Epigenomics Core University of Michigan), Ilona Kryczek (University of Michigan), Weiping Zou (University of Michigan), and Ajjai Alva (University of Michigan).

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 clinical trials and observational studies that seek to improve the lives of cancer patients in the diverse communities we serve by leveraging the scientific and clinical expertise of Big Ten universities. The Big Ten Cancer Research Consortium creates a unique team research culture to drive science rapidly from ideas to treatment and prevention. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow. Since its founding, the Big Ten CRC has activated nearly 40 clinical trials across a wide range of cancer types, more than 1,000 participants have enrolled in Big Ten CRC studies, and more than 500 researchers have joined Big Ten CRC Clinical Trial Working Groups.

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