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

Project: Research project

Project Details

Description

Hypothesis:
1. PDL1 and CTLA-4 inhibition will result in clinical benefit (stable disease, partial or complete response) in patients with metastatic HER2-negative breast cancer.
2. PDL1 and CTLA-4 inhibition will result in prolonged progression-free survival (PFS) and overall survival (OS).
3. PDL1 and CTLA-4 inhibition will be safe with a favorable side effect profile.
4. Tissue and serum based biomarkers will act as predictors of response to PDL1 and CTLA-4 blockade and result in pharmacodynamic modulation.

Objectives:
1. To evaluate clinical benefit rate in patients with metastatic HER2-negative breast cancer treated with PDL1 and CTLA-4 inhibition.
2. To evaluate the PFS and OS.
3. To evaluate safety and toxicity.
4. To evaluate if tissue-based biomarkers (IHC expression of PDL1; tumor infiltrating lymphocytes (TILs); T cell subpopulations; changes in tissue and peripheral T-cell receptor genotype; human leukocyte antigen (HLA) genotype; and immune-related candidate gene signatures) predict response to treatment and demonstrate pharmacodynamic effects.
StatusFinished
Effective start/end date1/1/1612/31/18

Funding

  • Avon Products Foundation, Inc. (Avon Grant No. 02-2015-036)

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