Combo Immunotherapy for Triple Negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.
Will I have to stop taking my current medications?
The trial requires that you stop any cancer-directed therapy at least 3 weeks before starting the study treatment. If you are on systemic immunosuppressive agents, including certain steroids, you must stop them 3 weeks before joining the trial. Inhaled steroids are allowed.
Is the combo immunotherapy for triple-negative breast cancer safe?
Pembrolizumab, a part of the combo immunotherapy, can cause immune-related side effects in some patients, such as inflammation in different parts of the body. In studies, these side effects were seen in about 64% of patients, with 20% experiencing more severe reactions. It's important to monitor and manage these side effects during treatment.12345
What makes the Combo Immunotherapy for Triple Negative Breast Cancer unique?
This treatment is unique because it combines multiple immunotherapy agents, including Celecoxib, Interferon Alpha-2, Pembrolizumab, and Rintatolimod, which work together to enhance the body's immune response against cancer cells. Unlike standard chemotherapy, this combination aims to boost the immune system's ability to fight cancer, potentially offering a novel approach for patients with triple-negative breast cancer.26789
What data supports the effectiveness of the drug pembrolizumab in treating triple-negative breast cancer?
Who Is on the Research Team?
Ellis Levine, MD
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with triple negative breast cancer that has spread or can't be surgically removed. They must have normal bilirubin levels, agree to use contraception, and not have had cancer treatment in the last 3 weeks. Patients should be able to take oral meds, have measurable disease, and a performance status indicating they are relatively active.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rintatolimod, celecoxib, and interferon alpha-2b, followed by pembrolizumab. Treatment includes IV and oral administration over a 2-week cycle, with pembrolizumab every 3 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including CT/MRI scans and blood sample collection.
Open-label extension (optional)
Participants may opt into continuation of treatment long-term to assess long-term safety and efficacy.
What Are the Treatments Tested in This Trial?
Interventions
- Celecoxib
- Interferon Alpha-2
- Pembrolizumab
- Rintatolimod
Celecoxib is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
National Cancer Institute (NCI)
Collaborator