MK-3475 for Metastatic Inflammatory Breast Cancer (MIBC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02411656|
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : June 25, 2018
You are being asked to take part in this study because you have inflammatory breast cancer (IBC) or triple negative breast cancer (TNBC) that is metastatic (has spread to other parts of the body).
The goal of this clinical research study is to learn if pembrolizumab (also called MK-3475 and Keytruda) can help to control metastatic IBC and TNBC. The safety of this drug will also be studied.
This is an investigational study. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. Its use in patients with metastatic IBC and TNBC is investigational. The study doctor can describe how the study drug is designed to work.
Up to 35 participants will be enrolled in this study. All will take part in at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: MK-3475 Behavioral: Follow Up/Phone Call||Phase 2|
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive pembrolizumab by vein over about 30 minutes on Day 1 (+/- 3 days) of each 21-day cycle.
On Day 1 of each cycle:
- You will have a physical exam.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
At Cycles 3, every 3rd cycle after that (Cycles 6, 9, 12, and so on), and if the disease gets worse, blood (about 10 tablespoons) will be drawn for biomarker and immune system testing.
About every 2 Cycles, you will have imaging scans to check the status of the disease as part of standard of care. .
Length of Study:
You may continue taking the study drug for up to 24 months, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
After you stop receiving the study drug:
- You will have a physical exam.
- Blood (about 10 tablespoons) will be drawn for routine tests.
- You will have the same imaging scans you had at screening to check the status of the disease.
About 1 and 3 months after the last dose of study drug, you will be asked about your health and any side effects you may have had. You may be asked during a routine clinic visit or you may be called. If you are called, each call should last about 2 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer (IBC) or Non-IBC Triple Negative Breast Cancer (TNBC) Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
MK-3475 200 mg administered on Day 1 of each 21 day cycle as a 30 minute infusion by vein for up up to 24 months.
Follow up or phone call about 1-3 months after last dose of study drug.
200 mg administered on Day 1 of each 21 day cycle as a 30 minute infusion by vein.
Behavioral: Follow Up/Phone Call
About 1 and 3 months after last dose of study drug, participant to have follow up or phone call. If participant is called, each call should last about 2 minutes.
- Disease Control Rate [ Time Frame: 4 months ]Disease control rate defined as the percentage of patients either 1) with measurable disease that maintain complete response (CR) or partial response (PR), or upgrade from PR to CR, or 2) with non-measurable disease that remain CR or stable disease (SD), or upgrade from SD to CR, by 4 months or more in all evaluable patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411656
|Contact: Naoto Ueno, MD, PHD||713-792-2817|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PHD||M.D. Anderson Cancer Center|