Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers
Summary
This is a Phase II, single arm study looking at the rate of major clinical response and non-operative management in Stage II and III colon cancer after 18 weeks (up to 6 cycles) of neoadjuvant dostarlimab.
Detailed description
The purpose of this research study is to look at the effects of the immunotherapy drug dostarlimab on dMMR colon cancer tumors and to see if these patients can avoid surgical resection, with the option to go to surgery only if the tumor does not respond.
Arms & interventions
- DrugDostarlimab
Participants will receive Dostarlimab 500 mg IV every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for 8 cycles until 1.5 years
Outcome measures
Primary
Major Clinical Response (MCR) Rate
MCR rate is defined as the proportion of patients meeting the following criteria at 18 weeks: 1) ctDNA is stable or declining, 2) a clinically asymptomatic primary tumor, and 3) no metastatic disease.
Time frame: From Dostarlimab initiation to 18 weeks.
Secondary
Metastasis-Free Survival (MFS) Prior to Surgery
Time frame: From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.
Progression-Free Survival (PFS)
Time frame: From treatment Dostarlimab until study completion, up to 5 years.
Overall Response Rate (ORR)
Time frame: From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.
Eligibility criteria
Study locations (2)
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53792