A Study Of Pembrolizumab In Combination With Trastuzumab-DM1
Brief description of study
This research study is studying a combination of drugs as a possible treatment for metastatic
The interventions involved in this study are:
- Trastuzumab emtansine (also called T-DM1)
Clinical Study Identifier: NCT03032107
Detailed Study Description
This research study is a Phase I clinical trial, which tests the safety of an investigational
intervention and also tries to define the appropriate dose of the investigational
intervention to use for further studies. "Investigational" means that the intervention is
being studied. It also means that the FDA (U.S. Food and Drug Administration) has not
approved the combination of Pembrolizumab and T-DM1 for use in patients, including people
with your type of cancer.
This study will determine what amount (or dose) of Pembrolizumab and of T-DM1 is safe for
people to take and what effects, good or bad, this combination may have on participants and
The FDA has not approved Pembrolizumab for this specific disease but it has been approved in
the United Sates for the treatment of other types of cancer.
The FDA has approved Trastuzumab emtansine (T-DM1) as a treatment option for this type of
The combination of Pembrolizumab and T-DM1 is investigational. It is thought that together
these drugs to help get the immune system to attack tumor cells and kill cancer cells that
have the HER2 protein. However, it is not known if giving the two study drugs at the same
time will have a better anti-cancer effect than giving each treatment on its own.