Colorectal NeoplasmsPhase 1NCT02559024
Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer
A Phase 1 study testing MEDI6469 in people with Colorectal Neoplasms, run by Providence Health & Services at 1 site in United States.
Trial summary
This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the immune cell environment within colorectal cancer metastases. The drug will be administered to patients before surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- MEDI6469
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2016to Oct 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
- Patients who will undergo staged liver resections are included in this study. In these cases, preoperative MEDI6469 will be given prior to the initial procedure.
- Patients with small <3 cm tumors located >2 cm away from central bile ducts will be considered for either radiofrequency ablation or resection, the choice of which will be determined at the time of surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Laboratory values during preoperative assessment within the protocol specified range
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
- No active gastrointestinal bleeding.
- No clinical or laboratory coagulopathy
- Anticipated lifespan greater than 12 weeks
Who cannot join
- Metastatic disease outside of the liver that is not considered surgically resectable or curable.
- Active infection.
- Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire.
- Previous treatment with mouse monoclonal antibodies.
- Need for chronic maintenance oral steroids.
- Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
- Enrollment in a clinical trial in which a different investigational agent is administered within 4 weeks prior to the first dose of MEDI6469.
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/Ib Study of Surgical Resection or Radiofrequency Ablation (RFA) of Metastatic Lesions in the Liver in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Metastatic Colorectal Cancer
This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the immune cell environment within colorectal cancer metastases. The drug will be administered to patients before surgical treatment.
Read the detailed description
There will be three distinct cohorts of patients which will vary the timing of the MEDI6469 dose, starting three weeks before surgery and decreasing the interval before surgery by one week with each cohort, as long as no dose-limiting toxicity attributable to the anti-OX40 are observed.
Immunohistochemistry will be used to measure the immune cells within primary and metastatic tumors when resected tissue is available, and surgically ablated tumors, giving each specimen an "immune score". The primary endpoint of the study will be the difference in immune scores of patients treated with anti-OX40 compared to historical controls (immune scores of untreated patients). Secondary endpoints will include both clinical (survival) and immunological data (specific measurements of immune cell populations based on flow cytometry and immunohistochemistry).
- Conditions
- Colorectal Neoplasms
- Being tested
- MEDI6469
- Keywords
- Metastatic colorectal cancer, liver lesion, anti-OX40 antibody, MEDI6469, Immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI6469Drug
Also called anti-OX40 antibody, CD134
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days
| Study group | Role | What they receive |
|---|---|---|
| 21 Days | Experimental | MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery Receives: Drug: MEDI6469 |
| 14 Days | Experimental | MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery Receives: Drug: MEDI6469 |
| 7 Days | Experimental | MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery Receives: Drug: MEDI6469 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (side-effects or complications related to the study drug)
Patients are seen at least 7 times in clinic and have 3 physical exams and provide interim medical history four times to identify potential side-effects or complications related to the study drug.
Measured: 48 Days
Immune Score
The number of CD8 effector T cells, CD4 regulatory T cells, the expression of activation markers OX40, CD38 and HLA-DR.
Measured: 27 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start14 Mar 2016
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: Drug expired and access to additional supply ended. PI left the institution shortly afterwards and the study will not be re-activated. Only 4 patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Pippa Newell, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559024
- Sponsor's protocol ID
- 14-102A
- Status last verified
- Jan 2022
- First submitted
- 22 Sep 2015
- Last updated
- 14 Feb 2022
- 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 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/Ib Study of Surgical Resection or Radiofrequency Ablation (RFA) of Metastatic Lesions in the Liver in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02559024
- Acronym / sponsor ID
- 14-102A
- Conditions
- Colorectal Neoplasms
- Keywords
- Metastatic colorectal cancer, liver lesion, anti-OX40 antibody, MEDI6469, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug expired and access to additional supply ended. PI left the institution shortly afterwards and the study will not be re-activated. Only 4 patients were enrolled.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 24 Sep 2015 (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 ability of an immune modulator, anti-OX40 (MEDI6469) to alter the immune cell environment within colorectal cancer metastases. The drug will be administered to patients before surgical treatment.
Detailed description
There will be three distinct cohorts of patients which will vary the timing of the MEDI6469 dose, starting three weeks before surgery and decreasing the interval before surgery by one week with each cohort, as long as no dose-limiting toxicity attributable to the anti-OX40 are observed.
Immunohistochemistry will be used to measure the immune cells within primary and metastatic tumors when resected tissue is available, and surgically ablated tumors, giving each specimen an "immune score". The primary endpoint of the study will be the difference in immune scores of patients treated with anti-OX40 compared to historical controls (immune scores of untreated patients). Secondary endpoints will include both clinical (survival) and immunological data (specific measurements of immune cell populations based on flow cytometry and immunohistochemistry).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 21 Days | Experimental | Drug: MEDI6469MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery |
| 14 Days | Experimental | Drug: MEDI6469MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery |
| 7 Days | Experimental | Drug: MEDI6469MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who will undergo staged liver resections are included in this study. In these cases, preoperative MEDI6469 will be given prior to the initial procedure.
- Patients with small <3 cm tumors located >2 cm away from central bile ducts will be considered for either radiofrequency ablation or resection, the choice of which will be determined at the time of surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Laboratory values during preoperative assessment within the protocol specified range
- Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
Key exclusion criteria (7 listed)
- Metastatic disease outside of the liver that is not considered surgically resectable or curable.
- Active infection.
- Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire.
- Previous treatment with mouse monoclonal antibodies.
- Need for chronic maintenance oral steroids.
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 |
|---|---|---|
| MEDI6469Also: anti-OX40 antibody, CD134MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days | Drug | 14 Days, 21 Days, 7 Days |
Primary outcome
Safety (side-effects or complications related to the study drug)
Time frame: 48 Days
Patients are seen at least 7 times in clinic and have 3 physical exams and provide interim medical history four times to identify potential side-effects or complications related to the study drug.
Immune Score
Time frame: 27 Days
The number of CD8 effector T cells, CD4 regulatory T cells, the expression of activation markers OX40, CD38 and HLA-DR.
Results and safety
The study was stopped early (reason given: Drug expired and access to additional supply ended. PI left the institution shortly afterwards and the study will not be re-activated. Only 4 patients were enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- 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.
Pippa Newell, MD principal investigator
Providence Health & Services
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 Colorectal Neoplasms, 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Feb 2022. 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 was stopped early (reason given: Drug expired and access to additional supply ended. PI left the institution shortly afterwards and the study will not be re-activated. Only 4 patients were enrolled.). Results are not available in the source record.
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?
Safety (side-effects or complications related to the study drug) (time frame: 48 Days). The study lists 2 primary outcomes in all. 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 14 Feb 2022.