February 15, 2023:

Investigators of two Big Ten CRC studies presented their findings during the American Society of Clinical Oncology Genitourinary (GU) Cancers Symposium on February 16-18, 2023, in San Francisco, CA. Sara E. Fenton, MD, PhD of Northwestern University will present a Big Ten Cancer Research Consortium prostate cancer study and Yousef Zakharia of the Iowa Holden Comprehensive Cancer Center will present on a renal cell carcinoma study. 

Additionally, the Big Ten CRC GU clinical trial working group will meet in-person during the conference on Thursday, February 16th at 6 AM PT / 8 AM CT / 9 AM ET. Call in information is available for investigators to join virtually.

Abstract # 174 | Poster #F11

The abstract titled “A phase I trial of androgen deprivation, darolutamide, and ipatasertib in a safety cohort with castration-resistant prostate cancer (ADDITION)” was featured during Poster Session A: Prostate Cancer in the Prostate cancer-advanced, prostate cancer-localized track (subtract therapeutics) on February 16 at 11:30 AM PT.

BTCRC-GU19-404 is a single arm, phase I/II trial of neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men with localized, high risk prostate cancer led by David VanderWeele, MD at Northwestern University.

The goal of the study was to estimate the efficacy of neoadjuvant androgen deprivation, darolutamide, and ipatasertib in men with previously untreated, localized, high-risk prostate cancer that is lacking PTEN, as measured by the pathological complete response or minimal residual disease. The PTEN gene provides instructions for making an enzyme that is found in almost all tissues in the body. 

In this abstract, investigators found that combination therapy with darolutamide and ipatasertib in castration resistant prostate cancer is safe and a recommended phase 2 dose of ipatasertib was established.

Participating institutions include Northwestern University and Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

Authors include Sarah Elizabeth Fenton, Rachel Springsdorf, Siobhan Kenny, Ashley Ross, Masha Kocherginsky, Maha H. A. Hussain, David James VanderWeele, Lauren Bere.

Abstract #696 | Poster #J9

The abstract titled, “Final results of phase Ib/II study of durvalumab and guadecitabine in advanced clear cell renal cell carcinoma (ccRCC) and biomarker analysis” was featured during Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers and presented by Yousef Zakharia, MD. 

BTCRC-GU16-043 is a Single Arm Phase Ib/II Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer aimed to estimate the safety and toxicities of durvalumab in combination with guadecitabine in patients with metastatic clear cell renal cell carcinoma.

Authors include Yousef Zakharia, Eric A. Singer, Satwik Acharyya, Rohan Garje, Monika Joshi, David J. Peace, Veera Baladandayuthapani, Claudia Laancette, Ilona Kryczek, Weiping Zou, Ajjai Shivaram Alva

Participating institutions include University of Illinois Cancer Center, Holden Comprehensive Cancer Center, University of Iowa, University of Michigan Rogel Cancer Center, Penn State Cancer Institute, Rutgers Cancer Institute of New Jersey

About the Big Ten Cancer Research Consortium: The Big Ten cancer centers have united 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 Big Ten Cancer Research Consortium creates a unique team-research culture to drive science rapidly from ideas to treatment-changing paradigms. 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