Phase II Study of Regorafenib and Lorigerlimab for Treating Localized Rectal Cancer That Has Returned or Grown Back

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07223567

Provider View

This clinical trial is testing a combination of two drugs, regorafenib and lorigerlimab, to see if they are safe and effective in treating rectal cancer that has come back or grown after initial treatment. The study focuses on patients whose cancer has not spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining regorafenib and lorigerlimab in patients with rectal cancer that has returned or grown locally after initial treatment. Researchers aim to see how well this combination works in reducing cancer cells before surgery and to assess the overall response to the treatment.

Description

The main goal of this study is to see how well the combination of regorafenib and lorigerlimab works in reducing cancer cells in patients with rectal cancer that has come back or grown locally after initial treatment. Researchers will measure the amount of cancer left after treatment and surgery to determine the effectiveness of the drugs.

Secondary goals include evaluating the overall response rate to the treatment, the rate of complete cancer removal during surgery, and the time it takes to reach surgery after starting the treatment. The study will also look at the need for permanent ostomy and the rate of complete clinical response.

Participants will receive the drug combination and undergo surgery to remove the cancer. The study will monitor the safety and effectiveness of the treatment, as well as any side effects experienced by the participants.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of rectal cancer.
  • Cancer must have specific characteristics (MSS or pMMR) as determined by standard tests.
  • Evidence of cancer regrowth or local recurrence after initial treatment.
  • Potential for complete surgical removal of the cancer.
  • Willing to undergo a biopsy of the cancer.
  • Good overall health with a performance status of 0 or 1.
  • Ability to understand and sign a consent form.
  • Ability to swallow pills.
  • Adequate organ and bone marrow function based on specific blood test results.
  • Adequate heart function.
  • Willing to use effective contraception during and after the study if of childbearing potential.

Exclusion Criteria

  • Cancer has spread to distant parts of the body.
  • Previous re-irradiation for recurrent cancer.
  • Prior treatment with certain immune therapies or regorafenib.
  • Use of other cancer treatments not part of the study.
  • Recent use of investigational drugs.
  • Need for systemic steroids or immunosuppressive medications.
  • Gastrointestinal issues affecting drug absorption.
  • History of certain gastrointestinal or autoimmune diseases.
  • Recent severe allergic reactions to similar treatments.
  • History of organ transplant or recent heart issues.
  • Uncontrolled infections or other serious health conditions.
  • Recent major surgery or injury.
  • Other cancers within the last 3 years, except for certain types.
  • Recent live vaccine administration.
  • Active viral infections like hepatitis or HIV.
  • Use of certain medications that interact with study drugs.
  • Pregnant or nursing women.

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