Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Summary

This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system.

This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.

Conditions

• Stage III Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer
• Invasive Breast Carcinoma
• Recurrent Breast Carcinoma
• Triple-Negative Breast Carcinoma
• Unresectable Breast Carcinoma

Interventions

BIOLOGICAL

Anti-OX40 Antibody PF-04518600

Given IV

DRUG

Avelumab

Given IV

DRUG

Binimetinib

Given PO

BIOLOGICAL

Utomilumab

Given IV

DRUG

Liposomal Doxorubicin

Given IV

DRUG

Sacituzumab Govitecan

Given IV

Sponsors & Collaborators

• Translational Breast Cancer Research Consortium

  collaborator OTHER

• Hoosier Cancer Research Network

  collaborator OTHER

• Array BioPharma

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• Breast Cancer Research Foundation

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Gilead Sciences

  collaborator INDUSTRY

• Laura Huppert, MD, BA

  lead OTHER

Principal Investigators

• Laura Huppert, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-08

Primary Completion

2027-01-31

Completion

2027-01-31

FDA Drug

Yes

Countries

• United States

Study Locations