Study on Rintatolimod, Celecoxib, and Interferon Alpha 2b with Pembrolizumab for Treating Advanced Triple Negative Breast Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05756166

Provider View

This clinical trial is testing a new combination of treatments for patients with triple negative breast cancer that has spread or cannot be removed by surgery. The study aims to find the safest and most effective dose of these treatments and see if they can help the immune system fight the cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with triple negative breast cancer that has either spread to other parts of the body or cannot be surgically removed. The treatment combines three drugs—rintatolimod, celecoxib, and interferon alpha 2b—with pembrolizumab, an immunotherapy drug. The goal is to see if this combination can safely and effectively help the immune system target and attack cancer cells, potentially improving outcomes for patients.

Description

The main goal of this study is to evaluate the safety of a new treatment combination for patients with advanced triple negative breast cancer. This combination includes rintatolimod, celecoxib, and interferon alpha-2b, along with pembrolizumab. Researchers want to determine if this combination is safe and how well it works compared to other treatments.

The study will also look at how long patients live without the cancer getting worse, their overall survival, and how well the cancer responds to the treatment. Additionally, researchers will examine how the treatment affects the immune system and the cancer environment.

The study is divided into two parts. In the first part, researchers will find the best dose of interferon alpha-2b. In the second part, they will test the treatment's effectiveness. Patients will be divided into two groups:

  • Group 1: Patients will receive rintatolimod, celecoxib, and interferon alpha-2b for two weeks, followed by pembrolizumab every three weeks for up to four doses. They will also have scans and blood tests.
  • Group 2: Patients will receive the same initial treatment but will start pembrolizumab earlier and continue every three weeks. They will also have scans, blood tests, and possibly a tumor biopsy.

The study will involve regular monitoring through scans and blood tests to assess the treatment's impact on the cancer and the patient's health.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of triple negative breast cancer that cannot be removed by surgery or has spread.
  • Have been informed about other treatment options.
  • Have a tumor that can be biopsied and agree to the procedure.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Agree to use effective birth control methods if of childbearing potential.
  • Be able to swallow and retain oral medication.
  • Have measurable disease according to standard criteria.
  • Have not received cancer-directed therapy for at least three weeks before starting the study treatment.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Understand the study and agree to sign informed consent.

Exclusion Criteria

  • Currently taking systemic immunosuppressive medications, including high-dose steroids.
  • Have active autoimmune disease or a history of organ transplantation.
  • Are pregnant or breastfeeding.
  • Are unwilling or unable to follow study requirements.
  • Have serious mood disorders, such as major depression.
  • Have recent or severe heart problems, such as a heart attack or heart failure.
  • Have a history of severe gastrointestinal issues, such as ulcers or bleeding.
  • Have had allergic reactions to NSAIDs or any study drugs.
  • Have any condition that makes participation unsafe, according to the investigator.
  • Have a positive test for antinuclear antibodies.
  • Have a known history of HIV infection.
  • Have active hepatitis B or C infections.

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