Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Soli⦠(NCT04165772) | Clinical Trial Compass
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
United States200 participantsStarted 2019-12-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Willing and able to provide written informed consent for the trial.
* Be ā„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 with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Nonchildbearing potential is defined as follows (by other than medical reasons):
* ā„45 years of age and has not had menses for \>1 year
* Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in theā¦
What they're measuring
1
Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months