Actively Recruiting
Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
Led by University of Iowa · Updated on 2025-05-25
25
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow study procedures and provide informed consent (or have a representative consent if mild cognitive impairment).
- 18 years or older.
- Biopsy confirmed dMMR Stage II or III colon cancer suitable for surgical removal.
- Biopsy tissue available for specific immune marker testing or willing to have repeat biopsy.
- Willing to delay surgery if study treatment shows response.
- ECOG performance status of 0 or 1.
- No metastatic disease on recent CT scan.
- Adequate blood counts: neutrophils ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL.
- Kidney and liver function within specified limits.
- For those who can become pregnant, negative pregnancy test and agreement to use contraception during and after treatment.
- For males, use of contraception during and after treatment.
You will not qualify if you...
- More than one primary tumor present.
- Bowel obstruction, perforation, or severe bleeding needing urgent surgery or transfusion.
- Tumors classified as Clinical T4b.
- Allergy to dostarlimab or its components.
- Major surgery within 3 weeks before starting treatment.
- Recent use of investigational therapies.
- Active or severe bleeding from tumor requiring surgery.
- Other active cancers within past two years.
- Uncontrolled illnesses such as infections, heart conditions, or psychiatric issues.
- Active autoimmune diseases treated systemically in past 2 years.
- Immunodeficiency or recent immunosuppressive therapy.
- Severe immune-related side effects from prior immunotherapy.
- HIV infection with recent opportunistic infections.
- Organ transplant recipients.
- Active hepatitis B or untreated hepatitis C infections.
- History of interstitial lung disease.
- Recent live vaccine within 30 days.
- Insufficient biopsy tissue for testing.
- Severe cognitive impairment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
S
Saima Sharif, MD, MS
CONTACT
A
Alisha Demsky
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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