Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono Research & Development Institute, Inc.
With
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Study participants have histologically or cytologically confirmed TNBC
Absence of human epidermal growth factor receptor 2 (HER2), estrogen receptor, and progesterone receptor expression must be documented (criteria for defining TNBC are outlined in the protocol)
Participants must have received at least one line of systemic therapy for metastatic disease and have progressed on the line of therapy immediately prior to study entry. There is no limit to the number of prior therapies
Participants may prescreen for HMGA2 expression while on preceding treatment, however screening should only occur if in the opinion of the Investigator, the participant would likely be eligible for study within 6 months
Participants must have measurable disease
Availability of either archival tumor tissue or fresh core or excisional biopsy of a tumor lesion (primary or metastatic, excluding bone biopsies) is mandatory to determine HMGA2 expression level prior to enrollment
HMGA2 high tumor expression is required and will be determined by a central lab
Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
Participants have a life expectancy greater than or equal to (\>=) 12 weeks as judged by the Investigator at study start
Participants have adequate hematological, hepatic and renal and coagulation function as defined in the protocol
You may not be if
Participants must not have received prior cancer treatment with any other immunotherapy or checkpoint inhibitors, or any other immune-modulating monoclonal antibody
Participants that received any organ transplantation, including stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
Participants with significant acute or chronic infections
Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
