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

212 Participants
are divided into 3 treatment groups

Locations

10
Hartford Healthcare (Data Collection)06102, HartfordConnecticut, United States
Baptist Alliance MCI (Data Collection Only)33143, MiamiFlorida, United States
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth - Limited Protocol Activities07748, MiddletownNew Jersey, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Tesaro, Inc.

Collaborator