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MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer

NCT02536794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-17

Study results available
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Summary

The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.

Conditions

  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer

Interventions

BIOLOGICAL

Anti-B7H1 Monoclonal Antibody MEDI4736

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

BIOLOGICAL

Tremelimumab

Given IV

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Avon Breast Cancer Foundation

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • Cesar Santa-Maria, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-14
Primary Completion
2020-02-06
Completion
2021-01-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02536794 on ClinicalTrials.gov