Study on Using PD-1 Blockade for Treating Locally Advanced Mismatch Repair Deficient Solid Tumors

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04165772

Provider View

This clinical trial is testing a new drug, TSR-042, to see if it can effectively treat advanced solid tumors with a specific genetic feature called mismatch repair deficiency. The study will also assess the safety of the drug when used with standard chemotherapy and radiation therapy, followed by surgery.

Patient Parameters

Program Overview

The aim of this study is to determine if the drug TSR-042, when used before standard chemotherapy and radiation therapy, followed by surgery, can effectively treat solid tumors that have a genetic feature known as mismatch repair deficiency. The study will also evaluate the safety of TSR-042 in this treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Must be willing and able to provide written consent to participate.
  • Must be 18 years or older.
  • Must have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a confirmed diagnosis of a locally advanced solid tumor.
  • Tumors should typically be treated with therapy before surgery.
  • No evidence of cancer spread to distant parts of the body.
  • Must have a tumor that can be measured or evaluated by doctors.
  • Tumor must show mismatch repair deficiency through specific tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for 150 days after the last dose.
  • Must have stable corticosteroid use if applicable.
  • Must have a heart rhythm within normal limits.
  • Must have adequate organ function based on blood tests, including:
    • Sufficient white blood cells, platelets, and hemoglobin levels.
    • Normal kidney and liver function.
    • Normal blood clotting times unless on stable anticoagulation therapy.

Exclusion Criteria

  • Cancer that has spread or returned.
  • Previous treatment with radiation, chemotherapy, or surgery for the tumor.
  • For colorectal cancer patients, tumors causing bowel obstruction unless a temporary ostomy is in place.
  • Other invasive cancers within the last 5 years, except for certain skin or cervical cancers.
  • Immune system deficiencies or recent use of high-dose steroids or other immune-suppressing drugs.
  • Active autoimmune diseases needing treatment in the past 2 years.
  • Active infections needing treatment.
  • Previous treatment with drugs targeting T-cell pathways.
  • Severe immune-related side effects from past immunotherapy.
  • Use of other cancer treatments or experimental therapies during the study.
  • Known HIV or active Hepatitis B or C infections.
  • Pregnant or breastfeeding women, or men planning to father children during the study and for 150 days after.
  • Medical or psychiatric conditions that could interfere with participation.
  • Recent live vaccinations.
  • Recent major surgery or significant injury.
  • History of lung disease.
  • Allergies to TSR-042 or its components.

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