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NCT ID: NCT04546009 Active, not recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Start date: October 9, 2020
Phase: Phase 3
Study type: Interventional

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

NCT ID: NCT04544449 Active, not recruiting - Clinical trials for Multiple Sclerosis, Primary Progressive

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

FENtrepid
Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

NCT ID: NCT04544436 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Start date: November 26, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.

NCT ID: NCT04515186 Active, not recruiting - Clinical trials for Cutaneous Leishmaniases

Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World

Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.

NCT ID: NCT04493853 Active, not recruiting - Clinical trials for Hormone-Sensitive Prostate Cancer

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

CAPItello-281
Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

NCT ID: NCT04475939 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

ZEAL-1L
Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

NCT ID: NCT04456673 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

NOTUS
Start date: July 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

NCT ID: NCT04447755 Active, not recruiting - Clinical trials for Relapsed or Refractory Solid Tumors

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)

E7080-G000-231
Start date: July 30, 2020
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response.

NCT ID: NCT04380636 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

Start date: July 6, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

NCT ID: NCT04305496 Active, not recruiting - Clinical trials for Locally Advanced (Inoperable) or Metastatic Breast Cancer

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

CAPItello-291
Start date: April 16, 2020
Phase: Phase 3
Study type: Interventional

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.