Track topics on Twitter Track topics that are important to you
The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.
The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs Overall Survival (OS) compared to placebo and chemotherapy in all participants and in participants with PD-L1 positive tumors.
Prior treatment with chemotherapy in the (neo)adjuvant setting is allowed. For such participants, the period between completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence must be ≥6 months. Participants who received taxane, gemcitabine, or platinum agents in the (neo)adjuvant setting can be treated with same class anticancer drug (taxane, gemcitabine, or carboplatin, respectively), if ≥12 months have elapsed between completion of treatment with curative intent and the first documented local or distant disease recurrence.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Triple Negative Breast Cancer (TNBC)
Pembrolizumab, Nab-paclitaxel, Paclitaxel, Gemcitabine, Carboplatin, Normale Saline Solution
Not yet recruiting
Merck Sharp & Dohme Corp.
Published on BioPortfolio: 2016-06-30T21:08:26-0400
This is a multi-center, open-label, Phase II clinical trial evaluating pembrolizumab in combination with carboplatin/paclitaxel as a treatment in unresectable locally advanced or metastati...
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/ENGOT-ov43)
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithe...
The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab. Pembrolizum...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not ye...
The investigators hypothesize that tumor cell killing by cytotoxic chemotherapy exposes the immune system to high levels of tumor antigens.The combination of Paclitaxel/Carboplatin and Pem...
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor, has demonstrated clinical efficacy in the treatment of advanced non-small cell lung cancer (NSCLC) either as monotherap...
The carboplatin/paclitaxel doublet remains the chemotherapy backbone for the initial treatment of ovarian cancer. This two-drug regimen, with carboplatin dosed using the Calvert formula, yielded convi...
The objectives of this study were to assess the feasibility of preoperative gemcitabine/nab-paclitaxel-based chemoradiation therapy (CRT) for patients with borderline resectable pancreatic cancer (BRP...
We present a patient with metastatic melanoma who had a complete response to second line chemotherapy with paclitaxel and carboplatin.
An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.
Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
A cyclodecane isolated from the bark of the Pacific yew tree, TAXUS BREVIFOLIA. It stabilizes MICROTUBULES in their polymerized form leading to cell death.
A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES).
Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL).
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Track and monitor developments in breast cancer research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...