Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer (NCT02559024) | Clinical Trial Compass
TerminatedPhase 1
Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer
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.
United States4 participantsStarted 2016-03-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 p…
What they're measuring
1
Safety (side-effects or complications related to the study drug)