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

Primary Purpose

Colorectal Neoplasms

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MEDI6469

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Metastatic colorectal cancer, liver lesion, anti-OX40 antibody, MEDI6469, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Portland Providence Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

21 Days

14 Days

7 Days

Arm Description

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery

Outcomes

Primary Outcome Measures

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.

Immune Score

The number of CD8 effector T cells, CD4 regulatory T cells, the expression of activation markers OX40, CD38 and HLA-DR.

Secondary Outcome Measures

Full Information

NCT ID

NCT02559024

First Posted

September 22, 2015

Last Updated

January 31, 2022

Sponsor

Providence Health & Services

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT02559024

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why 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.

Study Start Date

March 14, 2016 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Providence Health & Services

Collaborators

MedImmune LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

Keywords

Metastatic colorectal cancer, liver lesion, anti-OX40 antibody, MEDI6469, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

21 Days

Arm Type

Experimental

Arm Description

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery

Arm Title

14 Days

Arm Type

Experimental

Arm Description

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery

Arm Title

7 Days

Arm Type

Experimental

Arm Description

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery

Intervention Type

Drug

Intervention Name(s)

MEDI6469

Other Intervention Name(s)

anti-OX40 antibody, CD134

Intervention Description

MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days

Primary Outcome Measure Information:

Title

Safety (side-effects or complications related to the study drug)

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.

Time Frame

48 Days

Title

Immune Score

Description

The number of CD8 effector T cells, CD4 regulatory T cells, the expression of activation markers OX40, CD38 and HLA-DR.

Time Frame

27 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pippa Newell, MD

Organizational Affiliation

Providence Health & Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Portland Providence Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://oregon.providence.org/our-services/p/providence-cancer-center/

Description

Providence Cancer Center

Learn more about this trial

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

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