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

January 31, 2022 updated by: Providence Health & Services

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Portland Providence Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 Days
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.
27 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Collaborators

MedImmune LLC

Investigators

  • Principal Investigator: Pippa Newell, MD, Providence Health & Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-102A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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