Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Trial Parameters
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Brief Summary
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
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. * Negative pregnancy test done 72 hours prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception, for the course of the study starting wit