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 (Sep 2026). This Phase 2 trial studies multiple treatments including TSR-042 or Dostarlimab and capecitabine or 5-FU for rectal adenocarcinoma.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Colorectal Cancer
Tumor Agnostic
Biomarker criteria
Required: MLH1 loss
Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry
Required: MSH2 loss
Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry
Required: MSH6 loss
Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry
Required: PMS2 loss
Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry
Disease stage
Required: Stage III, FIGO 2009 STAGE I, FIGO 2009 STAGE II (other)
Excluded: Stage IV
Histologically confirmed locally advanced solid tumor (Cohorts 1 & 2); Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3); No evidence of distant metastases
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: Cohort 3: prior hormonal therapy for endometrial hyperplasia and/or endometrial cancer allowed if discontinued ≥1 week before first dose
Prior radiation therapy, chemotherapy, or surgery for tumor
Cannot have received: chemotherapy
Exception: Cohort 3: prior hormonal therapy for endometrial hyperplasia and/or endometrial cancer allowed if discontinued ≥1 week before first dose
Prior radiation therapy, chemotherapy, or surgery for tumor
Cannot have received: surgery for tumor
Exception: Cohort 3: prior hormonal therapy for endometrial hyperplasia and/or endometrial cancer allowed if discontinued ≥1 week before first dose
Prior radiation therapy, chemotherapy, or surgery for tumor
Cannot have received: antibody or drug targeting T-cell co-stimulation or checkpoint pathways
Cohort 1 & 3: Received prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
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 ≤1.5 × ULN OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥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: Hematological: ANC ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin >9 g/dL or ≥5.6 mmol/L. Renal: Serum creatinine ≤1.5 × ULN OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥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 →Frequently asked questions
Is NCT04165772 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MLH1?
Yes, MLH1 loss is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 loss is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or FIGO 2009 STAGE I or FIGO 2009 STAGE II 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 qualify