Alternative Drug Names:
MK-3475 is now Pembrolizumab (Keytruda brand in the US)
Purpose of Trial:
This is a phase 2 trial to determine the safety and efficacy of MK-3475 as a single drug in the setting of prior chemotherapy for metastatic IBC. MK-3475 has been FDA approved in other tumor types such as melanoma and non small cell lung cancer. MK-3475 is an antibody that is an immunotherapy drug belonging to the PD-1 class. Inhibiting PD-1 removes the brakes on T cells, so that they may kill tumor cells.
Why this study is relevant for IBC patients:
IBC tumors are known to frequently express PD-L1 (~38% are positive), a protein that binds to PD-1 and actively turns off T cells so the tumor cells can hide from the immune system. This drug can disrupt this loop so that the immune system can recognize and kill tumor cells around the body. This drug has produced some nice responses in other metastatic cancers, so this trial seeks to understand whether IBC patients might also benefit from this class of drug. This is the first trial in the world of a direct immunotherapy drug in IBC patients.
There are a number of other studies in adult populations with this drug that have demonstrated the safety profile and shown that it is better than chemotherapy for some patients. It appears tolerable without major serious side effects. An example of the frequency of side effects may be found in this abstract presented at ASCO in 2014. Since this drug is now FDA approved in several disease settings, the drug information website is https://www.keytruda.com
Patients with metastatic IBC that is HER2 negative (TNBC or ER+ is ok) are eligible for this trial if they have received 1 or 2 prior lines of therapy for metastatic disease and had a partial or complete response after 6-8 weeks minimum of treatment. Standard lab tests for organ function and blood cell counts must be within reasonable limits (see clinicaltrials.gov for details). The extent of your symptoms from metastatic IBC must not be too great, such that you must spend significant portion of your day in bed or require assistance with most activities of daily living.
There are a number of exclusion criteria including no prior immunotherapy drugs, and not being/becoming pregnant while on study.
MK-3475 is a liquid that is infused into your vein once every 3 weeks. The infusion is short (30 minutes). Everyone will receive the drug (i.e. no placebo). To participate in this trial, you will need to travel every 3 weeks to MD Anderson. Each cycle lasts 21 days. At each visit you will have a physical exam, and blood draws prior to receiving the infusion – then you will be able to go home. Scans to monitor response will be every 2 cycles, and if the results show that the drug is working, you will continue to receive it. You can stop at any time if the side effects are too intolerable. If you are responding and tolerating it well, you may continue this treatment for up to 24 months. After stopping the drug, you will receive 2 follow up phone calls from the research team that should last about 2 minutes each to document any lasting problems.
Location of Trial:
Only at MD Anderson Cancer Center in Houston, TX (NCI comprehensive cancer center)
For more information:
Contact the principal investigator, Dr Naoto Ueno at 713-792-2817
Is this study NCI Compliant?:
NCT trial number & link:
NCT# 02411656 Click for more info
Poster from scientific meeting: