RecruitingPhase 2NCT05239546

Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers


Sponsor

University of Iowa

Enrollment

25 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving the immunotherapy drug dostarlimab before surgery can shrink — or even eliminate — stage II and III colon cancer tumors that have a specific genetic feature called dMMR (deficient mismatch repair). If the tumor disappears completely, surgery might be avoided. **You may be eligible if...** - You are 18 or older with a biopsy-confirmed diagnosis of stage II or III dMMR colon cancer - Your cancer can be surgically removed - You are willing to possibly skip surgery if the cancer disappears after treatment - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have more than one primary colon tumor at the same time - Your tumor is causing a life-threatening blockage or severe bleeding - You have had a prior organ transplant - You have an active autoimmune disease or immunodeficiency - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

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NCT05239546


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