BESPOKE CRC Halfway to Enrollment Goal of Patients With Stage I-IV Resectable CRC

The developer has announced that half of the patients are now enrolled in the BESPOKE CRC clinical trial.

A total of 1000 patients with stage I to IV resectable colorectal cancer (CRC) from over 100 initiated sites across the United States have been enrolled in the BESPOKE CRC study (NCT04264702), meeting an enrollment milestone, according to an announcement by Natera, Inc.1

The target enrollment is 2000 patients across different stages of disease. Follow up will occur up to 5 years after surgery. The primary objective of the BESPOKE study is to quantify the real-world impact of Signatera testing on both adjuvant treatment decisions and clinical outcomes, compared to a historical control group. The investigators plan to conduct an interim analysis later in 2022 and report the results at a future congress.1 Secondary end points include evaluating molecular residual disease clearance as assessed by Signatera over a 2-year time frame, examining the percent of patients undergoing surgery for oligometastatic recurrence, evaluating survival, and exploring Signatera’s impact on patient quality of life.2

In the prospective, multi-center BESPOKE CRC study, treatment arm will consist of patients who have undergone surgery for stage I to IV CRC. Patients will receive Signatera test results, and patients’ physicians may recommend adjuvant chemotherapy. Patients will be followed for up to 2 years with periodic whole blood collection. The control arm will consist of patients with matched stage I to Stage IV CRC using the following criteria: sex, age of diagnosis and ECOG performance prior to adjuvant chemotherapy and a minimum of 3 evaluations per year. Control arm patients will have a minimum of 2 years follow-up data and received treatment no more than 3 years prior to study start date.2

"After the positive interim results from the CIRCULATE-Japan trial,3 we are eagerly awaiting results from BESPOKE CRC," said Scott Kopetz, MD, PhD, FACP, chair of the Colon Cancer Task Force at the National Cancer Institute, deputy department chair at the MD Anderson Cancer Center and coordinating investigator in the BESPOKE CRC trial, in a press release. "This study will give us important real-world insight into the implementation and utility of personalized MRD assessment in clinical practice."

"We are pleased to reach this milestone as patient recruitment continues to accelerate," said Adham Jurdi, MD, medical director of oncology at Natera, in the press release "This momentum speaks to the growing interest of Signatera among the oncology community, as a highly accurate tool to inform decision-making in the adjuvant and surveillance settings."

Signatera is a custom-built circulating tumor DNA test for treatment monitoring and molecular residual disease assessment in patients previously diagnosed with cancer. The Signatera test is personalized and tumor-informed, providing a customized blood test tailored to fit the unique signature of clonal mutations found in the patient’s tumor. The FDA granted Signatera 3 breakthrough device designations for multiple cancer types. The test is available for clinical and research use.

References

1. Natera achieves milestone of enrolling first 1,000 patients in its BESPOKE CRC study. PRNewswire. March 11, 2022. Accessed March 14, 2022. https://prn.to/3w4X4ss

2. BESPOKE study of ctDNA guided therapy in colorectal cancer. ClinicalTrials.gov. Updated September 22, 2021. Accessed March 14, 2022. https://clinicaltrials.gov/ct2/show/record/NCT04264702?term=BESPOKE&cond=CRC&draw=2&rank=1