OncoMatch/Clinical Trials/NCT05239546
Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
Is NCT05239546 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Dostarlimab for colon cancer.
Treatment: Dostarlimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR deficient mismatch repair (dMMR) by IHC
Biopsy proven dMMR (by IHC)
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational therapy
Received investigational therapy less than or equal to 3 months, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
Cannot have received: major surgery
Major surgery less than or equal to 3 weeks prior to initiating protocol therapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance 60mL/min using Cockcroft-Gault equation
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN; AST and ALT ≤ 3.0 x ULN
Absolute neutrophil count ≥ 1,500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9 g/dL; Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance 60mL/min; Total bilirubin ≤ 1.5 x ULN (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN; AST and ALT ≤ 3.0 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Iowa Hospitals & Clinics · Iowa City, Iowa
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05239546 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational therapy, major surgery disqualifies patients from enrollment.
Does this trial require MMR?
Yes, MMR deficient mismatch repair (dMMR) by IHC is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages