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

NCT02559024 | Terminated Phase 1

• 1 other identifier: 14-102A
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  48 Days

• Immune Score

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

  27 Days

Study Arms (3)

21 Days

EXPERIMENTAL

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

Drug: MEDI6469

14 Days

EXPERIMENTAL

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

Drug: MEDI6469

7 Days

EXPERIMENTAL

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

Drug: MEDI6469

Interventions

MEDI6469 DRUG

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

Also known as: anti-OX40 antibody, CD134

14 Days; 21 Days; 7 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• MedImmune LLC: collaborator

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pippa Newell, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 24, 2015
• Study Start: March 14, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)