Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions

NCT01862900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-03-21

No results posted yet for this study

Summary

This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor immune system response. This amplified and directed immune response could result in anti-tumor responses.

Conditions

Interventions

BIOLOGICAL

MEDI6469

Patients receive 3 doses of MEDI6469; one on Days 1, 3, and 5

Sponsors & Collaborators

  • Robert W. Franz Cancer Center

    collaborator UNKNOWN
  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER
  • MedImmune LLC

    collaborator INDUSTRY
  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Marka R Crittenden, MD, PhD · Providence Cancer Center, Earle A. Chiles Research Institute

  • Brendan Curti, MD · Providence Cancer Center, Earle A. Chiles Research Institute

  • Steven Seung, MD · Providence Cancer Center, Earle A. Chiles Research Institute

  • Alison Conlin, MD · Providence Cancer Center, Earle A. Chiles Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-27
Primary Completion
2016-05-17
Completion
2018-08-15

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862900 on ClinicalTrials.gov