Axatilimab + Pembrolizumab + Radiotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments, including pembrolizumab (a drug that helps the immune system fight cancer), axatilimab (an experimental treatment), and radiotherapy, for individuals with triple-negative breast cancer (TNBC). The goal is to determine how these treatments work together to slow or stop the growth of cancer that has spread or recurred after other treatments. Ideal participants have TNBC that has spread to other parts of the body, excluding the liver and bones, and have previously undergone immunotherapy. The trial aims to assess whether this treatment combination can better manage or reduce cancer in these patients. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroid therapy or certain cancer treatments, you may need to stop or adjust them before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have tested axatilimab at various doses. Some lab tests showed changes, mostly due to the drug's mechanism in the body, and these were not severe in most cases. Research has shown that axatilimab is generally well-tolerated.
Pembrolizumab has been widely studied and used in cancer treatment, with its safety well-known. Studies indicate that about 78% of patients experience significant side effects, which can vary depending on other treatments used alongside it. As a well-established treatment for certain cancers, its risks are well-documented.
Radiotherapy for breast cancer has improved quality of life, although it can sometimes cause skin issues or long-term changes in breast tissue. Most of these side effects can be managed.
Overall, each part of this treatment has undergone prior testing. While risks exist, especially when treatments are combined, they are known and monitored closely.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment combination because it brings together pembrolizumab, axatilimab, and radiotherapy to target breast cancer in a novel way. Pembrolizumab, an immunotherapy, helps the immune system recognize and attack cancer cells more effectively. Axatilimab adds a new angle by targeting a specific receptor involved in immune response, potentially boosting the effects of pembrolizumab. The use of radiotherapy aims to further weaken the cancer cells and make them more vulnerable to these treatments. This multi-faceted approach could offer a more powerful attack against breast cancer compared to standard treatments like chemotherapy or single-agent immunotherapies.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will evaluate the combination of pembrolizumab, radiotherapy, and axatilimab for breast cancer. Research has shown that combining pembrolizumab with radiotherapy is feasible and has manageable side effects. Although this combination has been studied before, limited information exists on its effectiveness for breast cancer. Pembrolizumab alone has a 4.7% success rate in treating a specific type of breast cancer called mTNBC. Axatilimab is a newer treatment, and researchers are still learning about its role in this combination. The trial aims to determine if using these treatments together can improve outcomes for breast cancer patients.678910
Who Is on the Research Team?
Stephen Shiao, MD
Principal Investigator
Cedars-Sinai Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with metastatic Triple-Negative Breast Cancer (TNBC) who are seeking additional treatment options. Participants should not have had prior immunotherapy and must be able to receive radiation therapy. Specific health conditions that could interfere with the study or pose a risk may exclude someone from participating.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pembrolizumab, Radiotherapy, and Axatilimab. Pembrolizumab is administered 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years. Radiotherapy is given as 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2. Axatilimab is administered 1 mg/kg, IV, Q2W starting 1 week post-RT C1D15/Week 3 until disease progression or treatment intolerance.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and overall survival.
Safety Monitoring
Safety, toxicity, and tolerability of the combination will be assessed by the number of adverse events related to study treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Axatilimab
- Pembrolizumab
- Radiotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stephen Shiao
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University