Purpose of this Study
We are doing this study to see if a pair of experimental drugs called botensilimab and balstilimab are safe and effective options for colorectal cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with unresectable or metastatic colorectal cancer
- Do not have metastases to the liver, bone, or brain
- Have not received prior therapy for their current cancer
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Get the study drug balstilimab by IV once every 2 weeks for up to 2 years
- Get the study drug botensilimab by IV on weeks 1, 7, 13, and 19 while you are getting balstilimab
- Receive standard anti-cancer drugs if your cancer does not improve on the study regimen
- Have your tumor biopsied
- Have blood draws
- Have regular CT or MRI scans
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Botensilimab and Balstilimab Optimization in Colorectal Cancer (BBOpCo)
Principal Investigator
Nicholas
DeVito
Protocol Number
PRO00115311
NCT ID
NCT06268015
Phase
II
Enrollment Status
Open to Enrollment