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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 (May 2026). This Phase 2 trial studies Dostarlimab for colon cancer.

Phase 2RecruitingUniversity of IowaNCT05239546Data as of May 2026

Treatment: DostarlimabThis 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.

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Extracted eligibility criteria

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

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