Pembrolizumab breast cancer trial

pembrolizumab breast cancer trial The purpose of this study is to examine the effectiveness and safety of pembrolizumab as first line or above treatment in patients with metastatic triple-negative breast cancer. Yuan Yuan, M. KEYNOTE-012 was a multicentre, open-label, phase 1b trial that included cohorts of patients with advanced gastric cancer, urothelial cancer, triple-negative breast cancer, and head and neck cancer. “The idea behind the trial is to use two drugs to try and increase the immune A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy About Metastatic Breast Cancer Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Subjects With Advanced Melanoma Failing Front-line Treatment With Checkpoint Inhibitors (CPI) or Triple Negative Breast Cancer (TNBC) Failing Front-line Chemotherapy for Metastatic Disease Pembrolizumab has shown some efficacy in metastatic breast cancer, but a new study experiments with its use in high-risk, early-stage breast cancers. It is a monoclonal antibody, a protein that binds to specific ligands, which increases the ability of the immune system to help detect and fight tumor cells. A combination of Keytruda (pembrolizumab) and Zejula (niraparib) has shown promising and durable response rates in triple-negative breast cancer patients, regardless of their BRCA mutational status, Phase 1/2 trial data show. The PD-1 inhibitor Keytruda (pembrolizumab) has demonstrated promising clinical activity with an acceptable safety profile in heavily pretreated patients with recurrent metastatic triple-negative breast cancer (TNBC). Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. Pembrolizumab is also being studied in the treatment of other types of cancer. A breast cancer specialist who was not involved in the study told Medscape Medical News that the results are encouraging, given that the majority of patients in the study had been heavily pretreated. This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). The U. 1) To describe the toxicity profile of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. This patient received the treatment in a clinical trial led by Steven A. Pembrolizumab Plus Standard Neoadjuvant Therapy for High-Risk Breast Cancer: Results From the I-SPY 2 Trial 1 Rita Nanda, Minetta C. This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy before surgery (neoadjuvant phase), followed by pembrolizumab alone after surgery (adjuvant phase) in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). 36 protocol(s) meet the specified criteria. A phase I trial testing MGA271, a B7-H3 antibody, and ipilimumab in patients with melanoma (NCT02381314), and a phase I study testing MGA217 and pembrolizumab in patients with refractory cancer, including melanoma (NCT02475213). Pembrolizumab (Keytruda) produced a “modest but durable” response in heavily pretreated women with PD-L1–positive, estrogen receptor (ER)-positive, HER2-negative advanced breast cancer, according to results from the KEYNOTE-028 trial which were recently published in Clinical Cancer Research. I. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. The goal of this optional sub-study is to collect leftover DNA and/or tissue samples for use in future research related to cancer. It is an IgG4 isotype antibody that blocks a protective mechanism of cancer cells, and allows the immune system to destroy those cancer cells. Dickler, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses an ongoing clinical trial of the CDK4/6 inhibitor abemaciclib combined with the PD-L1 inhibitor pembrolizumab (Keytruda) for patients with hormone receptor (HR)-positive, HER2-negative breast cancer. Keytruda is an anti-PD-1 human monoclonal antibody (mAb) designed to stop PD-1 from interacting with its ligands PD-L1 and PD-L2. Presented at the Oral Abstract Session at the 2018 ASCO Annual Meeting on Monday, June 4, 2018. Roy Herbst, MD, PhD of Yale School of Medicine, New Haven, CT talks about immunotherapy for lung cancer and early results of the trial of ramucirumab plus pembrolizumab in non-small cell lung cancer (NSCLC) (NCT02443324). Please see the links below for current open trials at UC San Francisco. In metastatic breast cancer, single-agent activity of pembrolizumab was observed but was higher in certain subsets, according to the results of the KEYNOTE-086 trial presented at the ASCO Meeting by Sylvia Adams, MD, of New York University School of Medicine. The researchers found that the patients receiving pembrolizumab medications have a better survival rate than chemotherapy alone at 12 months. Doctors may then treat them with pembrolizumab. According to Merck, pembrolizumab’s indication for recurrent metastatic cervical cancer is based on the KEYNOTE-158 trial, which investigated the efficacy of pembrolizumab in 98 patients with recurrent or metastatic cervical cancer, excluding patients with autoimmune disease or a medical condition that required immunosuppression. Our Keynote Oncology Clinical Trials are studying a way to treat cancer through immunotherapy – an approach that may help the body’s immune system fight cancer. An additional trial, KEYNOTE-355, is examining the use of chemotherapy with or without pembrolizumab in patients with previously untreated, locally recurrent NCTN Breast Cancer Trials (Open as of 9/17/2018) Protocol Number Phase Protocol Title A011106 III ALTernate Approaches for Clinical Stage II and III Estrogen Receptor Positive Breast Cancer NeoAdjuvant TrEatment (ALTERNATE) in S1418/BR006: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemotherapy. This research may include genetic research, biomarker testing (which may include genetic biomarkers), and pharmacogenetic (PGt) testing. There will be an initial safety run-in with 12 subjects from the TNBC and HR-positive cohort (~ 6 patients from each cohort). Phase 3 (phase III) trials study how well a new treatment (including surgical procedures) works compared to the standard treatment (standard of care). Photo by Scott Morgan. gov #NCT03200847). CHICAGO—Pembrolizumab led to superior overall survival (OS) among patients with previously untreated advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR or ALK mutations and PD This phase 2 trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple-negative breast cancer that has spread to other places in the body. The immunotherapy drug is already approved by the FDA for other forms of cancer. None of the breast cancer patients included in the initial pembrolizumab (anti-PD-1) trial showed any response to treatment and the combination of tremelimumab (anti-CTLA4) and exemestane in HR metastatic breast cancer demonstrated development of stable disease as best response in 42 % of patients [30, 31]. Of 25 participants who received pembrolizumab for their advanced disease, 12 percent saw tumors shrink by more than 30 percent, while the treatment stabilized disease in another 16 percent of patients. You may be offered the opportunity to take part in a clinical trial at some point during your treatment for breast cancer. Fueled by our improved understanding of the human genome, CTEP leads NCI’s effort to conduct innovative precision medicine treatment trials. Comment. 10, at the 2014 San Antonio Breast Cancer Symposium. More About Pembrolizumab Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. D. At the 2017 San Antonio Breast Cancer Symposium (SABCS), Sherene Loi, MD, PhD (Peter MacCallum Cancer Center, Melbourne, Australia), presented results from the phase Ib/II PANACEA study, which evaluated the combination of pembrolizumab and trastuzumab in 58 patients with HER2-positive metastatic breast cancer who had progressed on a prior This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy before surgery (neoadjuvant phase), followed by pembrolizumab alone after surgery (adjuvant phase) in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). Cyclin-dependent kinases play a key role in regulating cell cycle progression. Rexahn Pharmaceuticals Announces Clinical Collaboration with Merck to Evaluate RX-5902 (Supinoxin™) in combination with KEYTRUDA® (pembrolizumab) for Triple Negative Breast Cancer By Pembrolizumab (Keytruda) showed durable antitumor activity in patients with heavily pretreated metastatic triple-negative breast cancer (TNBC), according to findings from cohort A of the phase II Rexahn Pharmaceuticals Announces Clinical Collaboration with Merck to Evaluate RX-5902 (Supinoxin™) in combination with KEYTRUDA® (pembrolizumab) for Triple Negative Breast Cancer Key clinical point: Pembrolizumab appears safe and modestly active for treatment of ER-positive, HER2-negative advanced breast cancer that expresses PD-L1. Triple-negative breast cancer (TNBC) is a clinically heterogeneous and molecularly diverse disease. Patients with ER+ breast cancer to be enrolled in the pembro and vinorelbine arm. It is for people who have completed their main treatment for triple negative breast cancer (TNBC). Both pembrolizumab 2 mg/kg and pembrolizumab 10 mg/kg every 3 weeks provided superior overall survival compared with docetaxel, with similar outcomes for each pembrolizumab dose. The I-SPY 2 TRIAL (NCT01042379), sponsored by QuantumLeap Healthcare Collaborative, is a standing Phase 2 randomized, controlled, multi-center trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III), and is designed to screen promising new treatments and identify which therapies are most effective in specific patient The purpose of this study is to assess the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab for treating patients with stage IV triple negative breast cancer that has spread to other places in the body. However, in the subset receiving concurrent chemotherapy and In this trial, HIV-positive patients receiving combination antiretroviral therapy who have cancer that has recurred after or has not responded to previous treatment will receive intravenous pembrolizumab every 3 weeks until either their disease progresses or they experience unacceptable side effects. Rita Nanda, MD, speaks about a phase I trial of pembrolizumab in patients with advanced triple-negative breast cancer during a news conference Dec. Precision Cancer Medicine Precision medicine enables cancer specialists to identify and target cancer cells. The investigational immunotherapy used in the Keynote Oncology Clinical Trials is called pembrolizumab (MK-3475). A large clinical trial found that the immunotherapy drug pembrolizumab (Keytruda) is a more effective initial treatment and has less severe side effects than chemotherapy for most people with non-small cell lung cancer (NSCLC). triple-negative breast cancer (mTNBC). S. As an example, based on evidence that trastuzumab is synergistic with anti-PD-1 therapy, there is an ongoing international phase Ib/II trial (PANACEA) in which patients with HER2-positive breast cancer that has progressed on trastuzumab will receive trastuzumab in combination with pembrolizumab. In the trial, pembrolizumab was studied in The phase Ib/II trial - called PANACEA - will be conducted with the assistance of the International Breast Cancer Study Group (IBCSG) and will test the combination of Keytruda and Herceptin in HER2-positive breast cancer patients whose cancer has spread despite Herceptin therapy. Cancer clinical trials may open new doors of cancer screening, diagnosis and treatment options for you and your loved ones. The investiational agent will be tested in combination with pembrolizumab (Keytruda®, an anti-PD-1 therapy marketed by Merck**, in a phase Ib/II clinical trial as first line treatment for locally advanced and metastatic triple negative breast cancer or TNBC. They This content is made available for your personal use, educational advancement, or professional development. Results of the KEYNOTE-042 study – the largest clinical trial of the immunotherapy drug pembrolizumab as a standalone therapy, have demonstrated pembrolizumab to be more effective in most patients with the most common form of lung cancer, in comparison to the current standard-of-care, namely, chemotherapy. It may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “ nonsquamous ” and your tumor does not have an abnormal “EGFR” or “ALK” gene. Find a Clinical Trial Learn more about clinical trials at the OSUCCC – James and how you can participate. Major finding: The overall response rate was 12%, and the rate of grade 3 or 4 adverse events was 16%. The meeting dealt with the preliminary results of a Phase 1 trial (NCT01837095) showing that balixafortide is the first CXCR4 inhibitor to display signs of effectiveness against solid tumors. To compare invasive disease-free survival (IDFS) of The study will consist of two parts. . The FDA granted regular approval to pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following chemotherapy. KEYNOTE-012, which recruited patients with ≥1 % PD-L1 tumor cell positivity to receive pembrolizumab 10 mg/kg Q2W for up to 24 months, included head and neck cancer , gastric carcinoma , urothelial carcinoma , and triple-negative breast cancer (Table 1). , breast surgeon at the University of Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Approval was based on data from OlympiAD (NCT02000622), an open-label, multi-center clinical trial that randomized 302 patients with gBRCAm, HER2-negative metastatic breast cancer (2:1) to In the PERSEPHONE trial, among 4100 patients with HER2-positive early breast cancer, those randomly assigned to six months of adjuvant trastuzumab experienced noninferior four-year disease-free survival (DFS) rates relative to those receiving one year, with fewer cardiac events . Breast Cancer, Triple-Negative Breast Cancer Results from a phase Ib trial suggest that the programmed death 1 (PD-1) inhibitor pembrolizumab has activity and an acceptable toxicity profile as single-agent therapy in heavily pretreated, advanced triple-negative breast cancer (TNBC). 9–13. In Phase 1b Pembrolizumab will be used. , a breast oncologist who was the study’s lead author, is leading the triple-negative breast cancer accrual effort of that clinical trial. In this report, we describe the results of the cohort with advanced gastric cancer. Abstract 6016 - A phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with It has been odd to watch the CDK4/6 inhibitors succeed so well in a specific form of breast cancer, and yet Condition(s): Triple Negative Breast Cancer; Inflammatory Breast Cancer Stage IV Last Updated: May 3, 2018 Recruiting 48 A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors Furthermore, based on Bayesian predictive probability of success in a confirmatory Phase III trial, pembrolizumab graduated from the I-SPY 2 TRIAL for all subtypes in which it was tested, including triple negative breast cancer, all HER2-, and HR+/HER2-. Data from KEYNOTE-158 on pembrolizumab in advanced small-cell lung cancer (SCLC) from ASCO 2018 reported by Clinical Care Options (CCO). Patients with metastatic TNBC (ER/PR/HER2 negative) to be enrolled in the pembro plus gemcitabine arm. Unauthorized reproduction is prohibited. trial of single-agent pembrolizumab given intr avenously at 10 mg/kg every 2 weeks to patients with advanced PD-L1–positive (expression in stroma or $ 1% of tumor cells by immunohistochemistry) TNBC, gastric cancer, urothelial cancer, and hea d and neck cancer. Mark Robson, presented new data on OlympiAD study, a Phase III clinical trial comparing the single agent PARP inhibitor olaparib (Lynparza) to standard-of-care chemotherapy in patients harboring inherited mutations in BRCA1 or BRCA2 with HER2-negative metastatic breast cancer. It is important to note that irAEs can present after cessation of immunotherapy. " IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer (TNBC), an aggressive disease with limited treatment options," said Roche's Chief Medial Officer Sandra Horning in a July 2 statement, noting the drugmaker was "highly encouraged" by the results. Excerpt: “A phase I trial found promising activity and good tolerability with the combination of pembrolizumab and a stimulant of Toll-like receptor 9 (TLR9) known as SD-101 in patients with unresectable or metastatic melanoma, particularly in those who had not received prior anti–programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) therapy. Liu, Christina Yau, Smita Asare, Nola Hylton, Laura Van’t Veer, Jane Perlmutter, Anne M. investigator sponsored clinical trial in metastatic triple negative breast cancer and to be working A clinical trial is defined as a research study that evaluates new approaches to the prevention, diagnosis and treatment of cancer. The treatment paradigm of breast cancer has celebrated the successes of targeted therapy for decades. This is an open-label, single-arm, phase II study designed to investigate the pharmacodynamic and antitumor effects of denosumab alone and in combination with pembrolizumab in patients with unresectable PD-1/PD-L1 inhibitor-naïve regional and distant metastatic melanoma (AJCC stage III/IV) by performing translational research on peripheral blood and tumor tissue collected before and during As a cancer patient, you may take part in a clinical trial. Fulvestrant (also known as Faslodex®) is approved by the FDA to treat hormone receptor positive metastatic breast cancer. Niraparib administered orally, once-daily, at a dose of 200 milligrams is being evaluated in combination with 200 In patients with metastatic triple-negative breast cancer–a disease with no approved targeted therapies–infusion of pembrolizumab produced durable responses in almost one out of five patients enrolled in a phase-Ib clinical trial, according to data presented Dec. In patients with HR+/HER2- breast cancer, an absolute increase in the estimated pCR rate of 21 percent was observed in the KEYTRUDA (pembrolizumab) arm (based on the estimated pCR rate of 34% with Pembrolizumab was investigated in 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort (Cohort E) in Study KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label, multi-cohort trial. ” Maura N. Note that this phase 1b study of pembrolizumab, an immune-checkpoint inhibitor, showed some promise for the treatment of advanced, triple-negative breast cancer. At present, chemotherapy is the standard treatment for early-stage and metastatic TNBC. The results from the phase 1b KEYNOTE-012 trial were presented at the 2014 San The immunotherapy drug, Pembrolizumab, is effective in shrinking tumors among metastatic triple negative breast cancer patients as found in a clinical trial led by NYU Langone's Perlmutter Cancer This phase Ib /IIa trial studies the side effects and best dose of stereotactic body radiation therapy when given together with pembrolizumab in treating patients with melanoma or non-small cell lung cancer that has spread to other places in the body. Pembrolizumab has been found to be effective for metastatic triple negative breast cancer (mTNBC), according to an international clinical trial led by NYU Langone’s Perlmutter Cancer Center. In the combination setting, data for KEYTRUDA in NSCLC, TNBC and endometrial cancer, among others, will be presented. 5%) had an overall response including 1 complete response (3. The results mark the second early-stage trial to show antitumor activity with pembrolizumab in breast cancer. The vaccine is made separately for each patient. However, the immune checkpoint inhibitor pembrolizumab (Keytruda; Merck) may be effective in some patients, according to a report from the The goal of this clinical research study is to learn about the safety of giving the combination of pembrolizumab, carboplatin, and paclitaxel to patients with high-grade epithelial non-mucinous ovarian, primary peritoneal, or Fallopian tube cancer. But presence of immune cells in the tumor is a major additional This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Tumor cells are removed during surgery. Several lines of evidence support the study of immunotherapy in triple-negative breast cancer (TNBC). Keytruda (pembrolizumab) is a drug developed by Merck used in cancer therapy. This case study and other results from the ongoing trial show the potential of immunotherapy to target diverse tumors based on their DNA Most breast cancer patients do not die from their initial tumour, but from secondary malignant growths (metastases), where cancer cells are able to enter the blood and survive to invade new sites. Abstract. Methods a kind of lung cancer called non–small cell lung cancer (NSCLC). These trials can also include the study of patient quality of life/comfort, behavioral, psychosocial (the impact of cancer) and genetic questions that researchers would like to answer. Hershman DL, Unger JM, Greenlee H, et al. And the improvement appears to be lasting longer than would be expected with In a new clinical trial, his team is exploring the possibility of combining pembrolizumab with another therapy: a personalized vaccine. Usually, the FDA approves medicines to treat certain kinds of cancer, identified by their location in the body. . Pembrolizumab is an investigational immunotherapy that may help the body’s immune system attack cancer cells. , Ph. The trial investigated the drug in two The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. To compare the effects of MK-3475 (pembrolizumab) on Keytruda (pembrolizumab) was effective in treating triple-negative breast cancer regardless of whether women had received previous treatment, according to data presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. In a late breaking abstract presentation, Dr. Pembrolizumab has Abemaciclib is in Phase III development with two trials in HR+ breast cancer patients, as well as a Phase III trial in lung cancer. Back to Adult Cancers Cancer Type: Breast. The pembrolizumab clinical development programme includes patients with more than 30 tumour types in more than 160 clinical trials, including more than 80 trials that combine pembrolizumab with other cancer treatments. One of the 27 patients had a complete response During a press cast hosted by the American Society of Clinical Oncology ahead of the annual meeting, women with HER2-positive early-stage breast cancer who were treated with trastuzumab (Herceptin Pembrolizumab has been found effective for; 1) Melanoma (Skin Cancer), 2) Non-Small-Cell Lung Cancer (NSCLC), and 3) a certain type of head and neck cancer. Currently, the hormone receptor and HER2 statuses of a breast tumor continue to drive the selection of therapy for patients with early-stage breast cancer and metastatic breast cancer (mBC). In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. We assessed the safety and antitumor activity of the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab in patients with advanced TNBC. This is a two-part study of pembrolizumab monotherapy in participants with metastatic. Monoclonal antibodies, like pembrolizumab, may block specific proteins which may strengthen the immune system and control tumor growth. 10 at the San Antonio Breast Cancer Symposium. Phase 3 Clinical Development in Metastatic Breast Cancer During the third quarter of 2015, we initiated SOPHIA, a Phase 3 potential registration clinical trial of margetuximab in patients with metastatic breast cancer. The I-SPY 2 trial (NCT01042379) is a standing phase II randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (stage II/III), and is designed to screen promising new treatments and identify which therapies are most effective in specific patient subgroups based on molecular characteristics A trial of pembrolizumab and chemotherapy for triple negative breast cancer (KEYNOTE-355) We would like your feedback, please fill in our survey Please note - this trial is no longer recruiting patients. D This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can or cannot be removed by surgery. (May 31 issue) 1 compared pembrolizumab plus chemotherapy with chemotherapy alone in patients with untreated metastasic non–small-cell lung cancer. Please click on the protocol number to get more information about the trial. Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer Clinical Trial Details The patient population for this study will have had intensive treatments with chemotherapy and surgery prior to entry and randomization on this study. Several studies have shown a modest The Cancer Therapy Evaluation Program (CTEP) coordinates the clinical therapeutics development program of the Division of Cancer Treatment and Diagnosis (DCTD), NCI. The multi-center, non-randomized trial was designed to evaluate the safety, tolerability and antitumor activity of bi-weekly infusions of pembrolizumab (MK-3475, marketed as Keytruda®). gov, [NCT02447003][1]). The purpose of the Keynote breast cancer clinical trials is to see if the investigational drug, pembrolizumab, will slow down or stop the growth of breast cancer cells. Non-small cell lung cancer (NSCLC) patients with PD-L1 protein in their tumors lived significantly longer when treated with the immunotherapy Keytruda (pembrolizumab) than standard platinum-based chemotherapy, a Phase 3 clinical trial shows. Immune profiling of pre- and post-treatment breast cancer tissues from the S0800 randomized neoadjuvant trial of weekly nab-paclitaxel with or without bevacizumab and dose dense doxorubicin and cyclophosphamide. This is the first time the agency Pembrolizumab previously received accelerated approval for this indication in May 2017, based on the results of the KEYNOTE-021 clinical trial, which demonstrated improvements in overall response rate and progression-free survival (PFS) for patients being treated with pembrolizumab plus chemotherapy. The FDA has approved Trastuzumab emtansine (T-DM1) as a treatment option for this type of breast cancer In patients with metastatic triple-negative breast cancer -- a disease with no approved targeted therapies -- infusion of pembrolizumab produced durable responses in almost one out of five patients enrolled in a phase-Ib clinical trial, according to data presented Dec. A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments. The I-SPY 2 trial (NCT01042379), sponsored by QuantumLeap Healthcare Collaborative, is a standing Phase 2 randomized, controlled, multi-center trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III), and is designed to screen promising new treatments and identify which therapies are most effective in specific patient subgroups based on molecular characteristics The purpose of this clinical trial is to investigate the combination of CV301 (an experimental cancer vaccine) with Anti-PD-1 Therapy (Pembrolizumab) for treatment of non-small cell lung cancer. 7%) to pembrolizumab. Pembrolizumab will be administered every three weeks intravenously starting with Week 1. Oftentimes, these innovative studies can offer better options for specific circumstances than the current standard of care. A Multicenter, Open-label, Phase 2 Study of Imprime PGG and Pembrolizumab in Subjects With Advanced Melanoma Failing Front-line Treatment With Checkpoint Inhibitors (CPI) or Triple Negative Breast Cancer (TNBC) Failing Front-line Chemotherapy for Metastatic Disease Pembrolizumab (Keytruda) is an anti-PD-1 immunotherapy medicine that uses the body’s immune system to attack cancer cells. SAN ANTONIO —A phase Ib clinical trial to evaluate the efficacy and tolerability of pembrolizumab in patients with metastatic triple-negative breast cancer showed the drug was well tolerated and yielded durable responses, according to data presented at the 2014 San Antonio Breast Cancer Symposium, held Dec. Sylvia Adams, MD, medical oncologist, and associate professor at the NYU School of Medicine, discusses the latest research including the role of immunology in the treatment of triple negative metastatic breast cancer. Currently only recommended after tumor cell recurrence despite other treatments. The Clinical trial to study the efficacy and safety of Eribulin Mesylate taken with Pembrolizumab in patients with Triple-Negative Breast Cancer that has spread Polyphor is planning a pivotal clinical trial of its metastatic breast cancer therapy balixafortide (POL6326) after an encouraging meeting with U. The results of this “signal-seeking” trial suggest that some patients with heavily pretreated ER+/HER2− metastatic breast cancer may achieve sustained responses to monotherapy with pembrolizumab. 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. The planned clinical trial will evaluate the safety and efficacy of the combination in patients with inoperable locally advanced or metastatic triple negative breast cancer (TNBC) who have “We found that pembrolizumab essentially more than tripled the rate of pathologic complete responses in HER2- patients in the I-SPY 2 TRIAL,” said Andres Forero, MD, professor, division of hematology and oncology, and head of the breast cancer program, at University of Alabama at Birmingham. The new phase III clinical trial demonstrated that adding the immunotherapy drug pembrolizumab to chemotherapy doubled survival in people with metastatic nonsquamous non-small cell lung cancer 2 Department Of Breast And Medical Oncology, National Cancer Center Hospital, Tokyo/JP 3 Department Of Breast And Medical Oncology, National Cancer Center Hospital East, Chiba/JP 4 Department Of Surgery, Division Of Breast And Endocrine Surgery, Hyogo College of Medicine, Nishinomiya/JP In this international, double-blind, phase 3 trial, adults with newly diagnosed ES-SCLC, ECOG PS ≤ 1, and no previous systemic therapy for SCLC are randomized 1:1 to receive either EP plus a 200-mg fixed dose of pembrolizumab intravenously (IV) once every 3 weeks (Q3W) or EP plus pbo IV Q3W. 2) To estimate the progression free survival of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. In patients with metastatic triple-negative breast cancer, infusion of pembrolizumab produced durable responses in almost one out of five patients. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). A Phase II randomized trial of pembrolizumab with carboplatin and gemcitabine for treatment of patients with metastatic triple-negative breast cancer (mTNBC) [abstract]. CHICAGO — First-line pembrolizumab conferred longer median OS than chemotherapy among patients with non-small cell lung cancer and PD-L1 expression, according to results of the phase 3 KEYNOTE Breast, CB-1-17 (MK3475-522) A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC). The immunotherapy drug, Pembrolizumab, is effective in shrinking tumors among metastatic triple negative breast cancer patients as found in a clinical trial. Pembrolizumab (also known as Keytruda®) is approved the FDA to treat multiple cancers, but not approved to treat breast cancer. Chemotherapy with carboplatin plus paclitaxel or pemetrexed is currently the standard of care for treating NSCLC. In preclinical studies, RX-5902 has been shown to inhibit the growth and proliferation of multiple human cancer cell lines (including triple negative breast cancer), decrease tumor growth in patient derived xenograft models and potentiate the activity of immune checkpoint inhibitors and other anti-tumor agents. There will be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with 30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. Wallace, Amy Jo Chien, Andres Forero-Torres, Erin Ellis, Heather Han, Amy Sanders Clark, Kathy S. SAN ANTONIO —A combination of pembrolizumab (Keytruda) and trastuzumab, tested in patients with trastuzumab-resistant advanced HER2-positive breast cancer, was well tolerated and had clinical benefit in patients whose tumors were positive for a biomarker for pembrolizumab, according to data This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. REFERENCES. In a clinical trial sponsored by the makers of pembrolizumab, researchers administered 200 mg of pembrolizumab every three weeks to patients with triple negative breast cancer that had spread to This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Non-Small Cell Lung Cancer Question Is pembrolizumab monotherapy safe and effective in patients with previously treated gastric and gastroesophageal junction cancer?. This is a two-part study of pembrolizumab monotherapy in participants with metastatic triple-negative breast cancer (mTNBC). A Phase 1/2, Multicenter, Open-Label Trial of MG1 Maraba Expressing MAGEA3 (MG1-MAGEA3), with Adenovirus Vaccine Expressing MAGE-A3 (Ad-MAGEA3), in Combination with Pembrolizumab in Patients with Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With >= 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy Trial Design: KEYNOTE-086 is a 2-part, multicohort, nonrandomized, phase 2 trial of pembrolizumab monotherapy for women and men with mTNBC (ClinicalTrials. She also CHICAGO — Monotherapy with pembrolizumab safely led to durable responses in patients with heavily pretreated triple-negative breast cancer, according to results from a cohort of the KEYNOTE-086 The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). The planned clinical trial will evaluate the safety and efficacy of the combination in patients with inoperable locally advanced or metastatic triple negative breast cancer (TNBC) who have Combining pembrolizumab with conventional chemotherapy in the first-line setting significantly prolongs median overall survival (OS) in patients with metastatic squamous non–small cell lung cancer (NSCLC), according to data from the global phase III KEYNOTE-407 trial presented during the “Compelling Combinations: Raising the Bar With In the KEYNOTE-189 trial, Gandhi et al. These trials test novel medical, surgical and radiation treatments for Breast Cancer and to improve quality of life for patients. 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. Patients with ovarian cancer to be enrolled in the pembroplus liposomal doxorubicin arm. Participation eligibility With no approved targeted agents for triple-negative breast cancer (TNBC), women diagnosed with this disease have few treatment options besides chemotherapy. The KEYNOTE-012 study was a phase Ib multi-cohort study of pembrolizumab in patients with PD-L1-positive advanced solid tumours: triple-negative breast cancer, head and neck cancer, urothelial cancer, and gastric cancer. NCI Community Oncology Research Program - Protocol Summary SWOG S1418 - "Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy" In the first large, randomized trial to look at immunotherapy as a first-line cancer treatment, researchers found that adding the immunotherapy drug pembrolizumab to chemotherapy for advanced lung cancer led to better tumor control and overall survival than chemotherapy followed by pembrolizumab This clinical research study will evaluate the investigational study drug, pembrolizumab, or MK-3475, as a treatment in prostate cancer. Pembrolizumab was approved by the FDA in 2014 for the treatment of melanoma, a form of skin cancer. A multi-centre, open-label, randomized clinical trial comparing the efficacy and safety of the antibody-drug conjugate SYD985 to physician's choice in patients with HER2-positive unresectable locally advanced or metastatic breast cancer [BRE 299] Theraclion to Host Conference Call to Discuss First Immuno-Oncology Metastatic Breast Cancer Trial Combining Pembrolizumab and Echotherapy David Brenin, M. Pembrolizumab immunotherapy can help extend life in patients with non-small-cell lung cancer (NSCLC) when added to standard chemotherapy, according to an industry-conducted study presented at the American Association for Cancer Research meeting and published in the New England Journal of Medicine. Pembrolizumab (Keytruda) monotherapy as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) met its primary endpoint of overall survival in the Phase 3 TOPACIO is a Phase 1/2 clinical trial designed to evaluate the safety and efficacy of niraparib plus KEYTRUDA ® (pembrolizumab) in patients with recurrent, platinum-resistant ovarian cancer or triple negative breast cancer. A phase Ib clinical trial to evaluate the efficacy and tolerability of pembrolizumab in patients with metastatic triple-negative breast cancer showed the drug was well tolerated and yielded In monotherapy, data for KEYTRUDA (pembrolizumab) will be presented in NSCLC, melanoma, urothelial carcinoma, gastric cancer and triple-negative breast cancer (TNBC), among others. Pembrolizumab was also associated with fewer high-grade toxic effects than was docetaxel. These data establish pembrolizumab as a new treatment option for this population and validate the use of PD-L1 selection. Margetuximab is currently being studied as a potential treatment for metastatic breast cancer and gastroesophageal cancer. Findings Among 259 patients with previously treated gastric and gastroesophageal junction cancer enrolled in the phase 2 KEYNOTE-059 single-arm, multicohort trial, pembrolizumab demonstrated manageable safety. The Abramson Cancer Center is leading a new trial investigating pembrolizumab in head and neck cancer patients who are at high risk for recurrence or those with low-volume residual disease. This trial will evaluate the use of the immunotherapy agent, Pembrolizumab, (Keytruda) in people with advanced breast cancer associated with a BRCA mutation. The immunotherapy pembrolizumab (Keytruda) demonstrated on overall response rate (ORR) of 12% in patients with ER-positive, HER2-negative advanced breast cancer in the phase 1b KEYNOTE-028 trial, marking the second early-stage trial to show antitumor activity with this agent in breast cancer. gov identifier: NCT01848834) was a nonrandomized, multicohort, phase Ib study designed to evaluate the safety, tolerability, and antitumor activity of pembrolizumab in patients with advanced TNBC, gastric cancer, urothelial cancer, and head and neck cancer. Rexahn Pharmaceuticals Announces Clinical Collaboration with Merck to Evaluate RX-5902 (Supinoxin™) in combination with KEYTRUDA® (pembrolizumab) for Triple Negative Breast Cancer Results from another trial, KEYNOTE-028, showed that pembrolizumab was active in ER-positive, HER2-negative metastatic breast cancer. In previously reported data from the phase Ib KEYNOTE-012 trial, pembrolizumab LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial) (NCT03018080) Summary To take part in this study, you must have HER2-negative metastatic (stage IV) breast cancer. This trial is looking at the best time to introduce the immunotherapy drug pembrolizumab (Keytruda®)—cycle 2 or cycle 4—to stage IV breast cancer patients started on a regimen of tamoxifen and vorinostat (Zolinza®). KEYTRUDA may be used with the chemotherapy medicines pemetrexed and carboplatin as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type of lung cancer called “nonsquamous. The combo treatment of the two drugs, Pembrolizumab and Decitabine, is given four weeks before chemotherapy begins. Description. In 2017, an estimated 252,710 women will be diagnosed with breast cancer in the United States and an estimated 40,610 women will die from the disease. It was particularly heartening for City of Hope doctors and researchers that the treatment approach showed such a dramatic response in a triple-negative breast cancer patient. A randomized, Phase III trial to evaluate the efficacy and safety of MK-3475 (Pembrolizumab) as adjuvant therapy for triple receptor-negative breast cancer with ≥ 1 CM residual invasive cancer or positive lymph nodes (ypN+) after neoadjuvant chemotherapy; 2016 Nov 15 [cited 2017 Nov 12], [about 4 screens]. Earlier this year, the The APHINITY trial is a randomized controlled trial testing the addition of pertuzumab (Perjeta®) to standard adjuvant therapy –trastuzumab(Herceptin®) plus chemotherapy– in patients with HER2-positive breast cancer. After a drug (or other therapy) is found to be effective in treating breast cancer in a phase 2 trial, a phase 3 trial will study it further. Clinical trials are research studies that evaluate the safety and effectiveness of new treatment approaches for diseases. Excerpt: “The combination of abemaciclib (Verzenio) and pembrolizumab (Keytruda) showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer, according to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium (SABCS). Part 1 of the study will examine the efficacy and This study is the first phase-3 trial to examine pembrolizumab in combination with chemotherapy in treating non-small-cell lung cancer. In the I-SPY 2 clinical trial, adding the checkpoint blocker pembrolizumab (KeytrudaTM) to standard therapy dramatically improved response rates for patients with invasive triple-negative breast cancer (TNBC), tumors that lack estrogen and progesterone receptors as well as HER2. Rosenberg, M. 2 KEYNOTE-012 (ClinicalTrials. Summary. It is being tested now, and with promising early results, for the potential treatment of numerous other diseases. For example, patients with breast cancer enrolled in KEYNOTE 012 developed irAEs over a year after halting Pembrolizumab, an anti-PD-1 antibody, showed an acceptable safety profile and some efficacy in patients with heavily pretreated PD-L1-positive, advanced triple-negative breast cancer. Merck presented early-study data for Keytruda (pembrolizumab) in the treatment of advanced triple-negative breast cancer at the 2014 San Antonio Breast Cancer Symposium (SABCS) held this week. regulators. This trial is looking at finding circulating tumour DNA (ctDNA) from breast cancer. A new trial of pembrolizumab with and without ATRA offered at the UCHealth University of Colorado Hospital to adult patients with stage III or IV melanoma has started enrollment and is recruiting patients (ClinicalTrials. In this phase II trial, consolidation pembrolizumab improved time to metastatic disease or death and PFS compared with historical outcomes. Eisai today announced updated results of ENHANCE 1, a Phase 1b/2 trial investigating eribulin mesylate, in combination with pembrolizumab, in patients with metastatic triple-negative breast cancer . Acute Care Surgery, Trauma and Surgical Critical Care AIDS Malignancy Program Allergy and Inflammation Anesthesia, Critical Care and Pain Medicine Aortic Center Arthritis Center Beth Israel Deaconess HealthCare Biologic Therapy Program Blood Cancer Program Bone and Soft Tissue Sarcomas Program Brain Aneurysm Institute Brain Fit Club Brain Tumor PembroMab is a phase Ib/II trial evaluating the safety and efficacy of pembrolizumab and trastuzumab or ado-trastuzumab emtansine in patients with metastatic HER2+ breast cancer, regardless of PD KEYNOTE-012, which recruited patients with ≥1 % PD-L1 tumor cell positivity to receive pembrolizumab 10 mg/kg Q2W for up to 24 months, included head and neck cancer , gastric carcinoma , urothelial carcinoma , and triple-negative breast cancer (Table 1). With its state of art equipment, and nationally-ranked cancer specialists including top oncologists, surgeons, plastic surgeons, radiation oncologists, pathologists and radiologists (subspecialized in breast imaging), Jefferson Breast Care Center provides a wide range of breast care services for women and men. Part 1 of the study will examine the efficacy and safety of pembrolizumab monotherapy as first line or above treatment. The main objective is to examine overall response rate of pembrolizumab single agent therapy in advanced BRCA-mutated breast cancer. Results of a small clinical trial show that more than half the patients with Merkel cell carcinoma, a rare but aggressive type of skin cancer, improved when they took the immunotherapy drug Keytruda (pembrolizumab). Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a mid-clinical stage cancer immunotherapy that orchestrates an integrated anti-cancer immune response in combination with checkpoint inhibitors, as well as tumor-targeting or anti-angiogenesis monoclonal antibodies. Pembrolizumab (formerly MK-3475 and lambrolizumab, trade name Keytruda) is a humanized antibody used in cancer immunotherapy. Researchers designed a novel approach to immunotherapy that led to the complete regression of breast cancer in a patient for whom all other treatments failed. Of the 27 advanced triple-negative breast cancer patients in the Keynote-012 trial who could be evaluated, 5 patients (18. Phase II trial of concurrent chemoradiation with consolidation pembrolizumab in patients with unresectable stage III non-small cell lung cancer: Hoosier Cancer Research Network LUN 14-179. In December of 2014, Rita Nanda, MD, assistant professor of medicine at the University of Chicago, presented results at a conference from the phase-1b, multi-center KEYNOTE-012 trial, which assessed treatment with 10 milligrams per kilogram of pembrolizumab every two weeks for triple-negative breast cancer. Pembrolizumab has been FDA-approved for use in certain types of cancer. SAN ANTONIO – The immune checkpoint inhibitor pembrolizumab overcomes trastuzumab resistance in HER2-positive advanced breast cancer provided that the tumor expresses programmed death ligand 1 (PD-L1), a trial reported at the San Antonio Breast Cancer Symposium suggests. Find a Breast Cancer Trial at the University of Chicago Medicine Comprehensive Cancer Center. pembrolizumab breast cancer trial