Study on Adding Epacadostat to Pre-Surgery Chemoradiation for Locally Advanced Rectal Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03516708

Provider View

This clinical trial is exploring whether adding the drug epacadostat to standard radiation and chemotherapy before surgery can help treat locally advanced rectal cancer. The study is currently in its early stages and has not yet started recruiting for the Phase II portion.

Patient Parameters

Program Overview

The aim of this study is to see if the drug epacadostat, when combined with standard radiation therapy and chemotherapy (capecitabine and oxaliplatin), can improve treatment outcomes for patients with locally advanced rectal cancer before they undergo surgery to remove the tumor. The trial will initially involve 20 patients, who will be divided into two groups: one receiving standard treatment and the other receiving epacadostat along with standard treatment. The study will then expand to include more patients to evaluate the effectiveness of the treatment. Researchers will collect tumor and blood samples to understand how the treatment works and why it might be effective or not.

Description

This study is testing whether adding the drug epacadostat to the usual treatment of radiation and chemotherapy can improve outcomes for patients with locally advanced rectal cancer. The trial will start with 20 patients, who will be randomly assigned to either a group receiving standard treatment or a group receiving epacadostat in addition to standard treatment. The goal is to see if this combination can improve the body's immune response against the cancer and lead to better treatment results. Researchers will collect samples from patients to study how the treatment affects the cancer and the body. Up to 37 patients will participate, and the study will include people of any gender, race, or ethnicity. The trial will measure how well the treatment works by looking at tumor response, control of the disease, side effects, and survival rates.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with locally advanced rectal cancer and planning to receive pre-surgery radiation and chemotherapy.
  • At least 18 years old.
  • In good general health, able to perform daily activities with minimal restrictions.
  • Normal blood and organ function based on specific medical tests.
  • Willing to undergo study-related biopsies if enrolled at certain locations.
  • Women of childbearing age and men must agree to use birth control during the study and for 120 days after the last treatment.
  • Able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have received previous treatment for rectal cancer.
  • Have had certain types of immunotherapy or treatments targeting the IDO pathway.
  • Have had radiation or surgery in the pelvic area recently.
  • Have had another active cancer in the past 3 years, except for certain skin or localized cancers.
  • Currently taking other experimental drugs.
  • Have cancer that has spread to areas making surgery impossible.
  • Have metastatic disease or recurrent rectal cancer.
  • Have certain genetic conditions or active inflammatory bowel diseases.
  • Have allergies to study drugs or similar compounds.
  • Have an active infection requiring treatment.
  • Are taking warfarin (Coumadin) unless stopped and levels are normal.
  • Have a history of serotonin syndrome from certain medications.
  • Have uncontrolled health issues like heart failure or severe heart conditions.
  • Have an autoimmune disease requiring treatment in the past 2 years, with some exceptions.
  • Have an abnormal heart test that is concerning.
  • Have a digestive condition affecting drug absorption.
  • Have received a live vaccine recently.
  • Are pregnant or breastfeeding.
  • Have lung disease or active lung inflammation.
  • Have active tuberculosis.
  • Have active hepatitis B or C infections.
  • Have a specific type of rectal cancer with genetic instability.

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