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NCT ID: NCT03635567 Active, not recruiting - Cervical Cancer Clinical Trials

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

Start date: October 25, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).

NCT ID: NCT03635216 Active, not recruiting - Clinical trials for Uterine Cervical Neoplasms

The Biomarker Analysis in Locally Advanced Cervical Cancer

Start date: May 21, 2018
Phase:
Study type: Observational

Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. For optimizing cervical cancer treatment, the pathological prognostic factors determine whether to administer adjuvant therapy. However, the majority of clinical results was from squamous cell carcinoma, rendering conclusions for adenocarcinoma less convincing. We aimed to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery.

NCT ID: NCT03631706 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

NCT ID: NCT03631199 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

CANOPY-1
Start date: December 21, 2018
Phase: Phase 3
Study type: Interventional

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

NCT ID: NCT03618485 Active, not recruiting - Clinical trials for Myeloproliferative Neoplasms

Registry of Patients With MPNs in Taiwan

Start date: April 1, 2017
Phase:
Study type: Observational [Patient Registry]

Myeloproliferative neoplasms (MPNs) are a group of clonal hematologic malignancies with great variation in reported patient life expectancy and are characterized by a relatively indolent course which can be complicated by thromboembolic events and transformation to acute myeloid leukemia (AML). The MPNs in the 2016 World Health Organization (WHO) classification of myeloid neoplasms consist of polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) including prefibrotic/early stage and over fibrotic stage, chronic myeloid leukemia, other (rare) disorders such as chronic neutrophilic leukemia and chronic eosinophilic leukemia and MPN unclassifiable (MPN-U). The prevalence and genetic characteristics of patients with MPNs in Taiwan are still unknown. Molecular tests which are required for the diagnosis of MPNs are not available in many hospitals which hamper the accurate diagnosis and subtype classification of MPNs. Moreover, the information of current therapeutic strategy for MPNs in most medical centers in Taiwan is also not available. The purpose of this MPN registry is to collect clinical data, molecular characteristics, treatment details and response to therapy, occurrence of complications during the course, disease progression to secondary myelofibrosis from PV or ET and secondary AML (sAML) transformation as well as survival. The clinical and molecular data including the high molecular risk (HMR) genes will be examined and correlated with treatment outcomes in Taiwanese MPN patients. The Molecular Diagnostic Laboratory at Chang Gung Memorial Hospital-Linkou is a College of American Pathologists (CAP)-accredited lab which provides high quality of molecular genetic tests for hematologic malignancies. The three driver gene mutations are the major criteria for the diagnosis of MPN, the methodologies of mutational analyses have been well set up for the clinical use in this lab. In addition, this lab is also equipped with facilities for the detection of mutated genes which were recently identified as HRM category (presence of any of ASXL1, EZH2, SRSF2, IDH1 or IDH2), and mutations of other epigenetic regulators or splicing factors.

NCT ID: NCT03611712 Active, not recruiting - Survival Clinical Trials

PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT. The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms. The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.

NCT ID: NCT03607422 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

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

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03603184 Active, not recruiting - Endometrial Cancer Clinical Trials

Atezolizumab Trial in Endometrial Cancer - AtTEnd

AtTEnd
Start date: October 2, 2018
Phase: Phase 3
Study type: Interventional

Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Finally, in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Combinations of atezolizumab with chemotherapeutic agents and/or targeted therapies were studied in different solid tumors such as melanoma, NSCLC, renal cell carcinoma and colorectal carcinoma. From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents. Finally, preliminary results of a Phase Ia study of Atezolizumab (NCT01375842) monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017. Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 11.2 months. No G4-5 related AEs occurred. Regarding efficacy ORR was 13% [2/15] by RECIST. Atezolizumab seemed to have a favorable safety profile, with durable clinical benefit in some patients. Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.

NCT ID: NCT03600233 Active, not recruiting - Clinical trials for Neuroendocrine Tumors

Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

Start date: December 15, 2018
Phase: Phase 2
Study type: Interventional

CVM-1118 (TRX-818) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human is evaluated from the phase 1 study. The objectives of the phase 2 study is to further investigate the efficacy of CVM-1118 for patients with advanced neuroendocrine tumors.

NCT ID: NCT03596866 Active, not recruiting - ALK+ Advanced NSCLC Clinical Trials

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

ALTA-3
Start date: April 19, 2019
Phase: Phase 3
Study type: Interventional

Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: - Brigatinib tablets - Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.