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.
Willing and able to provide written informed consent for the trial.
Be ≥18 years of age on the date of signing informed consent.
ECOG performance status of 0 or 1.
Histologically confirmed locally advanced solid tumor (Cohorts 1 & 2)
Presence of metastatic or recurrent disease
Prior radiation therapy, chemotherapy, or surgery for tumor
For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.
Parallel
TSR-042 or Dostarlimab
DrugPatients will be given TSR-042/Dostarlimab at a dose of 500mg IV, over 30 minutes Q 3 weeks.
capecitabine or 5-FU
DrugCapecitabine 825mg/m2 BID concurrently with radiation per standard radiation guidelines. If patient is unable to tolerate oral medication, infusional 5-FU is an acceptable alternative.
Intensity Modulated Radiation Therapy (IMRT)
RadiationThe radiation dose is 5400 cGy to the tumor and surrounding nodes 4700 cGy to the pelvis, with an integrated boost to the primary tumor and involved nodes of receiving 5400cGy in 27fx.
Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months
To determine the pathologic complete response rate (pCR) or complete clinical response (cCR) rate at 12 months, after PD-1 blockade and with or without chemoradiation in subjects with mismatch repair deficient locally advanced adenocarcinoma.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Tesaro, Inc.
Collaborator
