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

NCT ID: NCT02559024

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-14
• Study Completion Date: 2018-10-31

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).

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

21 Days

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

Group Type: EXPERIMENTAL

MEDI6469

Intervention Type: DRUG

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

14 Days

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

Group Type: EXPERIMENTAL

MEDI6469

Intervention Type: DRUG

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

7 Days

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

Group Type: EXPERIMENTAL

MEDI6469

Intervention Type: DRUG

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

Interventions

MEDI6469

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

Intervention Type: DRUG

Other Intervention Names

anti-OX40 antibody; CD134

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pippa Newell, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

Portland Providence Medical Center

Portland, Oregon, United States

Countries

United States

Related Links

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

Providence Cancer Center

Other Identifiers

14-102A

Identifier Type: -

Identifier Source: org_study_id