INNATE: Immunotherapy During Pre-Surgery Treatment for Rectal Cancer

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04130854

Provider View

This clinical trial is exploring whether adding an immunotherapy drug to the standard pre-surgery treatment can improve outcomes for patients with locally advanced rectal cancer.

Patient Parameters

Program Overview

The study aims to find out if combining an immunotherapy drug with standard treatments before surgery can increase the rate of complete cancer disappearance in patients with locally advanced rectal cancer. The trial involves using short-course radiation therapy followed by chemotherapy, with or without an additional immunotherapy drug called APX005M, before surgery.

Description

This Phase II trial is testing a new approach for treating rectal cancer before surgery. Patients will be randomly assigned to receive either standard treatment or standard treatment plus an immunotherapy drug called APX005M. The standard treatment includes short-course radiation therapy and chemotherapy (mFOLFOX) before surgery. The study will enroll 58 patients, and an interim analysis will be conducted after 30 patients have completed treatment to assess the effectiveness and safety of the approach. Patients receiving APX005M will have one infusion during radiation therapy, followed by a break, and then continue with chemotherapy and APX005M for most of the chemotherapy cycles. After treatment, patients will be restaged and undergo surgery to remove the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, including all genders and ethnic groups.
  • Willing to provide written consent to participate.
  • Diagnosed with rectal adenocarcinoma.
  • Cancer must be at Stage III or Stage II with certain high-risk features, such as being very close to the anal ring or having specific tumor characteristics.
  • No previous treatment for rectal cancer.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Blood tests showing adequate organ and bone marrow function within 21 days before joining the study.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after.
  • Men must agree to use contraception during the study and for 90 days after.

Exclusion Criteria

  • Cancer has spread to distant lymph nodes or other parts of the body.
  • Previous radiation therapy to the pelvis.
  • Uncontrolled health conditions or infections that could interfere with the study.
  • Previous treatment with certain immune-targeting drugs.
  • Positive history for HIV/AIDS, HTLV, hepatitis B, or hepatitis C.
  • Active autoimmune diseases, except for certain stable conditions.
  • Need for systemic steroids or immunosuppressive drugs within 14 days before starting the study.
  • History of other cancers requiring treatment in the past 3 years, except for certain localized cancers.
  • Participation in other clinical trials or receiving investigational drugs.
  • History of lung disease or recent live vaccinations.
  • Psychiatric or social issues that could affect participation.
  • Pregnant or nursing women.
  • Not suitable for the full treatment plan.

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