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OncoMatch/Clinical Trials/NCT04165772

Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

Is NCT04165772 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TSR-042 or Dostarlimab and capecitabine or 5-FU for rectal adenocarcinoma.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT04165772Data as of May 2026

Treatment: TSR-042 or Dostarlimab · capecitabine or 5-FU — The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Tumor Agnostic

Disease stage

Required: Stage STAGE II (T3-4, N-), STAGE III (ANY T, N+)

Clinical Stage: Stage II (T3-4, N-); Stage III (Any T, N+); No evidence of distant metastases.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

Prior radiation therapy, chemotherapy, or surgery for tumor

Cannot have received: chemotherapy

Prior radiation therapy, chemotherapy, or surgery for tumor

Cannot have received: surgery

Prior radiation therapy, chemotherapy, or surgery for tumor

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin >9 g/dL or ≥5.6 mmol/L

Kidney function

Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥60 mL/min for subject with creatinine levels > 1.5 × institutional ULN

Liver function

Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN

Cardiac function

QTcF ≤ 450 msec, or ≤ 480 msec for participants with bundle branch block

Demonstrate adequate organ function as defined below within 14 days of Cycle 1, Day 1, all screening labs should be performed within 14 days of treatment initiation. Hematological: ANC ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin >9 g/dL or ≥5.6 mmol/L. Renal: Serum creatinine OR Measured or calculated(a) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥60 mL/min for subject with creatinine levels > 1.5 × institutional ULN. Hepatic: Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN. Cardiac: QTcF ≤ 450 msec, or ≤ 480 msec for participants with bundle branch block.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Hartford Healthcare (Data Collection) · Hartford, Connecticut
  • Baptist Alliance MCI (Data Collection Only) · Miami, Florida
  • Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities · Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth - Limited Protocol Activities · Middletown, New Jersey
  • Memorial Sloan Kettering Bergen - Limited Protocol Activities · Montvale, New Jersey

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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