Repair Deficient Solid Tumors

Phase II Study of Induction PD-1 Blockade in Subjects with Locally Advanced Mismatch Repair Deficient Solid Tumors. Attached to this email is the protocol and the SIV presentation materials. Additional documents can be found in iRIS.

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.

Key Inclusion Criteria:

• 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
• Solid tumors that in standard practice would be treated with neoadjuvant therapy
• No evidence of distant metastases.
  •    Radiologically measurable or clinically evaluable disease
• Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.

Available at the following locations: Hartford Hospital, Hospital of Central Connecticut and Midstate Medical Center