Expired Study
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Portland, Oregon 97213


Purpose:

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.


Study summary:

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).


Criteria:

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 prior to the first dose of MEDI6469.


Study is Available At:


Original ID:

14-102A


NCT ID:

NCT02559024


Secondary ID:


Study Acronym:


Brief Title:

Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Providence Health & Services


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

4


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pippa Newell, MD
Principal Investigator
Providence Health & Services

Study Dates

Start Date:March 14, 2016
Completion Date:September 2021
Completion Type:Anticipated
Primary Completion Date:September 2020
Primary Completion Type:Anticipated
Verification Date:October 2019
Last Changed Date:October 25, 2019
First Received Date:September 22, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Immune Score
Time Frame:27 Days
Safety Issues:False
Description:The number of CD8 effector T cells, CD4 regulatory T cells, the expression of activation markers OX40, CD38 and HLA-DR.
Outcome Type:Primary Outcome
Measure:Safety (side-effects or complications related to the study drug)
Time Frame:48 Days
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:MEDI6469
Description:MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days
Arm Name:21 Days
Other Name:anti-OX40 antibody

Study Arms

Study Arm Type:Experimental
Arm Name:7 Days
Description:MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery
Study Arm Type:Experimental
Arm Name:14 Days
Description:MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery
Study Arm Type:Experimental
Arm Name:21 Days
Description:MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Providence Health & Services
Agency Class:Industry
Agency Type:Collaborator
Agency Name:MedImmune LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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