CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Anti-B7H1 Monoclonal Antibody MEDI4736 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02536794
NCT02536794Phase 2Completed

A Single Arm Phase II Study Evaluating the Efficacy and Safety of MEDI4736 in Combination With Tremelimumab in Patients With Metastatic Her2 Negative Breast Cancer

Northwestern University·interventional·Posted Sep 1, 2015·Updated May 17, 2022

In Brief

A Phase 2 clinical trial evaluating Anti-B7H1 Monoclonal Antibody MEDI4736, Laboratory Biomarker Analysis, and 2 other interventions for Estrogen Receptor Negative and 4 related conditions. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 1, 2015
Enrollment StartJan 14, 2016
Primary CompletionFeb 6, 2020
Study CompletionJan 22, 2021
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.8 years ago

Interventions

Anti-B7H1 Monoclonal Antibody MEDI4736biological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Tremelimumabbiological

Given IV