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Merck 3475 Pembrolizumab · 1 trial · 1 indication
This outcome measure is designed to determine if immune modulation therapy with MK-3475 will increase TILs in newly diagnosed TNBC tumors. The mean percent change in TILS in tumor tissue from initial core biopsy samples will be compared with pathology samples from definitive surgery after two cycles of MK-3475.
| Arm | Type | Description |
|---|---|---|
| Single Arm open label | EXPERIMENTAL | Participants receive 'Merck 3475 Pembrolizumab' by vein one to two times before Intraoperative radiation therapy (IORT). The Intrabeam® Photon Radiosurgery System is a miniature electron beam-driven X-ray source which provides a point source of low energy X-rays (50 kV maximum) at the tip of a 3.2 mm diameter tube. The radiation source can be inserted into the area of interest immediately after excision of the tumor and switched on for 20-35 minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and early clinical applications of this device have been well studied and this is the device which was utilized in the international TARGIT trial. |
| Name | Type | Description |
|---|---|---|
| Merck 3475 Pembrolizumab | DRUG | Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of one to two cycles. |
| Intraoperative radiation therapy (IORT) | RADIATION | Participants will receive Intraoperative radiation therapy (IORT) on the day of surgery. |
Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be ≥ 21 years of age on day of signing informed consent. 3. Histologically proven invasive breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2...
Merck 3475 Pembrolizumab is being studied for use in triple negative breast cancer. It is an investigational oncology therapy currently in Phase 1 clinical development. The drug is being evaluated for its effects on the breast tumor microenvironment in patients with this condition.
Merck 3475 Pembrolizumab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational drug for the treatment of triple negative breast cancer.
Merck 3475 Pembrolizumab is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in an active clinical trial for triple negative breast cancer.
Merck 3475 Pembrolizumab is being studied in clinical trial NCT02977468, titled "Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer." This Phase 1 trial is recruiting female participants aged 21 years and older in the United States, with a planned enrollment of 15 patients.
Yes, Merck 3475 Pembrolizumab has been granted Priority Review designation by the U.S. Food and Drug Administration. This designation is intended to expedite the review process for drugs that may offer significant improvements in the treatment of serious conditions.