About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TSR-042 or Dostarlimab
- capecitabine or 5-FU
- Intensity Modulated Radiation Therapy (IMRT)
Treatment groups
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Tesaro, Inc.
Collaborator