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NCT ID: NCT03765918 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

NCT ID: NCT03755791 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

COSMIC-312
Start date: June 10, 2018
Phase: Phase 3
Study type: Interventional

This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

NCT ID: NCT03754790 Active, not recruiting - Hemophilia Clinical Trials

Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

ATLAS-OLE
Start date: January 9, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: - To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: - Bleeding episodes - Spontaneous bleeding episodes - Joint bleeding episodes - To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age

NCT ID: NCT03748641 Active, not recruiting - Clinical trials for Castration-Resistant Prostatic Cancer

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

MAGNITUDE
Start date: January 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

NCT ID: NCT03740165 Active, not recruiting - Ovarian Cancer Clinical Trials

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/KEYLYNK-001/ENGOT-ov43/GOG-3036)

Start date: December 18, 2018
Phase: Phase 3
Study type: Interventional

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 epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

NCT ID: NCT03737643 Active, not recruiting - Clinical trials for Advanced Ovarian Cancer

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

DUO-O
Start date: January 4, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

NCT ID: NCT03736499 Active, not recruiting - Quality of Life Clinical Trials

Endocrine Changes in Adults Undergoing Cardiac Surgery

Start date: July 1, 2018
Phase:
Study type: Observational

In this prospective study the investigators want to measure the serum level changes of the thyroid hormones (thyroid-stimulating hormone, reverse triiodothyronine, serum free T4), brain natriuretic peptide (BNP), testosterone and sexual hormone binding protein (SHBG) in adults undergoing cardiac surgery and search for correlations different psychosocial factors and analyze the influence on the survival and the length of ICU/hospital stay.

NCT ID: NCT03735121 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

NCT ID: NCT03734029 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body

NCT ID: NCT03725202 Active, not recruiting - Clinical trials for Giant Cell Arteritis (GCA)

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

SELECT-GCA
Start date: January 24, 2019
Phase: Phase 3
Study type: Interventional

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.