Metastatic Breast CancerPhase 1OX40 BreastNCT01862900
Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions
A Phase 1 study testing MEDI6469 in people with Metastatic Breast Cancer and Lung Metastases, run by Providence Health & Services at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Lung Metastases, Liver Metastases
- What is being tested?
- MEDI6469
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2012to 15 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Portland Providence Medical Center
Portland, Oregon, 97213
About this study
Official title: Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy.
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.
Read the detailed description
Patients will receive one of three different doses of SBRT depending on which cohort they are in. The doses are:
Cohort 1: 15 Gy (central tumors 10 Gy); Cohort 2: 20 Gy (central tumors 15 Gy); Cohort 3: 20 Gy x 2 (central tumors 15 Gy x 2).
In addition, all patients will receive three doses of MEDI6469. MEDI6469 is administered at 0.4 mg/kg IV over 60 minutes using in-line filter on Days 1, 3, and 5.
- Conditions
- Metastatic Breast Cancer, Lung Metastases, Liver Metastases
- Being tested
- MEDI6469
- Keywords
- Breast Cancer, Metastatic, Lung metastases, Liver metastases, Stereotactic body radiation, anti-OX40 antibody, MEDI6469, Immunotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI6469Biological
Patients receive 3 doses of MEDI6469; one on Days 1, 3, and 5
| Study group | Role | What they receive |
|---|---|---|
| 15 Gy | Experimental | Patients receive a radiation dose of 15 Gy to their liver or lung metastases. Patients receive a dose of MEDI6469 following radiation and on Days 3, and 5. Receives: Biological: MEDI6469 |
| 20 Gy | Experimental | Patients receive a radiation dose of 20 Gy to their liver or lung metastases. Patients receive a dose of MEDI6469 following radiation and on Days 3, and 5. Receives: Biological: MEDI6469 |
| 25 Gy | Experimental | Patients receive a radiation dose of 25 Gy to their liver or lung metastases. Patients receive a dose of MEDI6469 following radiation and on Days 3, and 5. Receives: Biological: MEDI6469 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose and safety profile of radiation administered in combination with anti-OX40 in patients with metastatic breast cancer.
A dose limiting toxicity (DLT) is defined as any greater than or equal to grade 3 non-hematologic toxicity (except hypothyroidism or vitiligo) that in the opinion of the investigator is considered at least possibly related to treatment. Grade 3 or 4 hematologic toxicities that take longer than 10 days to resolve will be considered DLTs. Patients will have 8 clinic visits over 36 days to identify toxicities.
Measured: From Day 1 to Day 36
Secondary outcomes (1)
Estimate the response rate of combined modality treatment in both irradiated and non-irradiated tumors.
Patients will have CT scans for tumor measurements at Day 36. Patients achieving a radiographic response, or are stable, will be followed monthly with physical exam and laboratory studies with CT (or other imaging as deemed appropriate) scans obtained every 3 months (± 2 weeks) for up to 24 months and then ever 6 months (± 2 weeks) for up to 4 years.
Measured: Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study start27 Apr 2012
- Primary completion17 May 2016
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Robert W. Franz Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute, MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Marka R Crittenden, MD, PhD, Principal investigator, Providence Cancer Center, Earle A. Chiles Research InstituteBrendan Curti, MD, Principal investigator, Providence Cancer Center, Earle A. Chiles Research InstituteSteven Seung, MD, Principal investigator, Providence Cancer Center, Earle A. Chiles Research InstituteAlison Conlin, MD, Principal investigator, Providence Cancer Center, Earle A. Chiles Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862900
- Sponsor's protocol ID
- 12-017A
- Acronym
- OX40 Breast
- Status last verified
- Aug 2018
- First submitted
- 22 May 2013
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy.
- ClinicalTrials.gov ID
- NCT01862900
- Acronym / sponsor ID
- OX40 Breast / 12-017A
- Conditions
- Metastatic Breast Cancer, Lung Metastases, Liver Metastases
- Keywords
- Breast Cancer, Metastatic, Lung metastases, Liver metastases, Stereotactic body radiation, anti-OX40 antibody, MEDI6469, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Robert W. Franz Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute, MedImmune LLC
- Study start
- 27 Apr 2012 (actual)
- Primary completion
- 17 May 2016 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will receive one of three different doses of SBRT depending on which cohort they are in. The doses are:
Cohort 1: 15 Gy (central tumors 10 Gy); Cohort 2: 20 Gy (central tumors 15 Gy); Cohort 3: 20 Gy x 2 (central tumors 15 Gy x 2).
In addition, all patients will receive three doses of MEDI6469. MEDI6469 is administered at 0.4 mg/kg IV over 60 minutes using in-line filter on Days 1, 3, and 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 Gy | Experimental | Biological: MEDI6469Patients receive a radiation dose of 15 Gy to their liver or lung metastases. Patients receive a dose of MEDI6469 following radiation and on Days 3, and 5. |
| 20 Gy | Experimental | Biological: MEDI6469Patients receive a radiation dose of 20 Gy to their liver or lung metastases. Patients receive a dose of MEDI6469 following radiation and on Days 3, and 5. |
| 25 Gy | Experimental | Biological: MEDI6469Patients receive a radiation dose of 25 Gy to their liver or lung metastases. Patients receive a dose of MEDI6469 following radiation and on Days 3, and 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI6469Patients receive 3 doses of MEDI6469; one on Days 1, 3, and 5 | Biological | 15 Gy, 20 Gy, 25 Gy |
Primary outcome
Determine the maximum tolerated dose and safety profile of radiation administered in combination with anti-OX40 in patients with metastatic breast cancer.
Time frame: From Day 1 to Day 36
A dose limiting toxicity (DLT) is defined as any greater than or equal to grade 3 non-hematologic toxicity (except hypothyroidism or vitiligo) that in the opinion of the investigator is considered at least possibly related to treatment. Grade 3 or 4 hematologic toxicities that take longer than 10 days to resolve will be considered DLTs. Patients will have 8 clinic visits over 36 days to identify toxicities.
1 secondary outcome
Estimate the response rate of combined modality treatment in both irradiated and non-irradiated tumors.
Time frame: Day 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marka R Crittenden, MD, PhD principal investigator
Providence Cancer Center, Earle A. Chiles Research Institute
Brendan Curti, MD principal investigator
Providence Cancer Center, Earle A. Chiles Research Institute
Steven Seung, MD principal investigator
Providence Cancer Center, Earle A. Chiles Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI6469 in people with Metastatic Breast Cancer and Lung Metastases, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose and safety profile of radiation administered in combination with anti-OX40 in patients with metastatic breast cancer. (time frame: From Day 1 to Day 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.