Avelumab Combinations for Triple Negative Breast Cancer
(InCITe Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there are specific 'washout' periods (time without taking certain medications) required for prior therapies, such as chemotherapy and radiation, before starting the trial. It's best to discuss your current medications with the study team to understand any necessary adjustments.
What data supports the effectiveness of the drug Sacituzumab Govitecan for treating triple-negative breast cancer?
Is sacituzumab govitecan safe for humans?
How is the drug combination of Avelumab, Liposomal Doxorubicin, and Sacituzumab Govitecan unique for treating triple-negative breast cancer?
This drug combination is unique because it includes sacituzumab govitecan, an antibody-drug conjugate that targets a specific protein (Trop-2) on cancer cells, delivering a potent chemotherapy agent (SN-38) directly to the tumor, which can improve survival outcomes compared to standard chemotherapy.13458
What is the purpose of this trial?
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.
Research Team
Laura Huppert, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for adults with stage IV or unresectable, recurrent triple negative breast cancer. Participants must be over 18, have an ECOG status of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. They should not have had more than two chemotherapy treatments in the metastatic setting nor more than one prior checkpoint inhibitor therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive a lead-in period of medications to stimulate the immune system
Treatment
Participants receive avelumab in combination with other therapeutic agents in cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Avelumab
- Binimetinib
- Liposomal Doxorubicin
- Sacituzumab Govitecan
Avelumab is already approved in European Union, United States, Japan for the following indications:
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laura Huppert, MD, BA
Lead Sponsor
Hope Rugo, MD
Lead Sponsor
Translational Breast Cancer Research Consortium
Collaborator
Hoosier Cancer Research Network
Collaborator
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Breast Cancer Research Foundation
Collaborator
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Array BioPharma
Industry Sponsor
Johns Hopkins University
Collaborator