Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions
This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor immune system response. This amplified and directed immune response could result in anti-tumor responses.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 21, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Providence Health & Services
- Interventions being studied
- Biological: MEDI6469
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically confirmed breast cancer with clinical evidence of stage 4 disease
- Measurable disease and at least one lesion in either liver or lung that is amenable to stereotactic body radiation
- One site of disease that will not receive radiation
- Patients with hormone receptor positive breast cancer must have received prior anti-hormonal therapy for metastatic disease and have progressed and patients with hormone receptor negative breast cancer must have received at least one prior chemotherapy regimen and progressed.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Women of childbearing potential must have a negative pregnancy test on the day treatment starts and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.
- Patients must have blood test results within pre-specified range
- No active bleeding
- No clinical coagulopathy (INR \<1.5, PT \<16 seconds, PTT \< 38 seconds) within 28 days
- Anticipated lifespan greater than 12 weeks
- Active infection requiring systemic antibiotics.
- Active autoimmune disease as defined by the autoimmune disease assessment tool.
- Previous treatment with mouse monoclonal antibodies
- At least 28 days since prior chemotherapy or monoclonal antibody therapy (trastuzumab or bevacizumab). Patients who have been on hormonal therapy can continue on therapy at the discretion of the investigator. Bisphosphonate therapy is acceptable during study participation.
- Diagnosis of a solid tumor malignancy (excluding non-melanoma skin cancer) within 3 years of enrollment.
- Need for chronic maintenance oral steroids.
- Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery or radiation and stable for at least 4 weeks and off steroids are eligible.
- No metastatic site amenable to SBRT
- Pregnant or lactating women, as treatment involves risks to the embryo or fetus.
- Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Portland Providence Medical CenterPortland, Oregon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 21, 2019. Always confirm current availability with the study team.