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

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ClinicalTrials.gov Identifier: NCT02559024
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Providence Health & Services

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: MEDI6469 Phase 1

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 14, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 21 Days
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery
Drug: MEDI6469
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days
Other Names:
  • anti-OX40 antibody
  • CD134

Experimental: 14 Days
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery
Drug: MEDI6469
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days
Other Names:
  • anti-OX40 antibody
  • CD134

Experimental: 7 Days
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery
Drug: MEDI6469
MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days
Other Names:
  • anti-OX40 antibody
  • CD134




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559024


Locations
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United States, Oregon
Portland Providence Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
MedImmune LLC
Investigators
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Principal Investigator: Pippa Newell, MD Providence Health & Services

Additional Information:
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02559024     History of Changes
Other Study ID Numbers: 14-102A
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Providence Health & Services:
Metastatic colorectal cancer
liver lesion
anti-OX40 antibody
MEDI6469
Immunotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Physiological Effects of Drugs
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Immunoglobulins
Immunologic Factors