RecruitingPhase 2NCT04165772

Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Dec 11, 2019

Study Type

INTERVENTIONAL

Conditions

Solid Tumor Solid Tumor, Adult Rectal Adenocarcinoma Clinical Stage: Stage II (T3-4, N-)Stage III (Any T, N+)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (specifically a PD-1 blocker, which releases the brakes on the immune system) before surgery or radiation can improve outcomes for patients with locally advanced solid tumors that have a DNA repair defect called mismatch repair deficiency (MMRd). These tumors tend to respond exceptionally well to immunotherapy. **You may be eligible if...** - You are 18 or older - You have a locally advanced solid tumor (not yet spread to distant organs) - Your tumor has been confirmed to have mismatch repair deficiency (by IHC, NGS, or PCR testing) - Your tumor would normally be treated with chemotherapy or radiation before surgery (neoadjuvant therapy) - You are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - Your tumor does not show mismatch repair deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTSR-042 or Dostarlimab

Patients will be given TSR-042/Dostarlimab at a dose of 500mg IV, over 30 minutes Q 3 weeks.

DRUGcapecitabine or 5-FU

Capecitabine 825mg/m2 BID concurrently with radiation per standard radiation guidelines. If patient is unable to tolerate oral medication, infusional 5-FU is an acceptable alternative.

RADIATIONIntensity Modulated Radiation Therapy (IMRT)

The radiation dose is 5400 cGy to the tumor and surrounding nodes 4700 cGy to the pelvis, with an integrated boost to the primary tumor and involved nodes of receiving 5400cGy in 27fx.