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NCT ID: NCT05238974 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants

MELODY
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

NCT ID: NCT05226598 Active, not recruiting - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

NCT ID: NCT05179603 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205]

Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

The is a phase 2 multi-cohort, un-controlled, non-randomized, open-label, multi-center study assessing the antitumor activity and safety of non-alpha interleukin (IL-2) SAR444245 with or without other anticancer therapies in participants aged 12 years and older with relapsed or refractory B cell lymphoma. This study is structured as a master protocol with separate sub studies designed to investigate the use of SAR444245 either with or without other anticancer therapies for the treatment of relapsed or refractory B cell lymphoma. Substudy 1-Cohort A aims to establish safety and preliminary anti-tumor activity for non-alpha interleukin (IL-2) SAR444245 combined with the anti-PD1 antibody, pembrolizumab in trial participants with classic Hodgkin lymphoma (cHL) who are anti-PD-(L)1-naive and have received at least 2 or 3 lines of systemic therapy. Substudy 3-Cohort C1 aims to establish safety and preliminary anti-tumor activity for SAR444245 as monotherapy in trial participants with diffuse large B-cell lymphoma (DLBCL). Trial participants in this study must have received at least 2 lines of systemic therapy and have either stable or progressive disease 1-3 months post Health Authority approved Chimeric Antigen Receptor T-cell (CAR-T) treatment when given as last systemic treatment prior to study enrollment.

NCT ID: NCT05173987 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Start date: February 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

NCT ID: NCT05171777 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

Start date: April 4, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

NCT ID: NCT05162586 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

Start date: March 31, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus [SCLE] and/or discoid lupus erythematosus [DLE]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.

NCT ID: NCT05144841 Active, not recruiting - Clinical trials for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

Start date: January 8, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.

NCT ID: NCT05127434 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Start date: November 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

NCT ID: NCT05116189 Active, not recruiting - Ovarian Cancer Clinical Trials

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

NCT ID: NCT05114824 Active, not recruiting - Anxiety Disorders Clinical Trials

Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Mental health problems -particularly depression- are the main cause of morbidity in young people (1), which has a known association with different health and social problems, such as increased alcohol consumption and drug dependence, adolescent pregnancy, school dropouts , criminal behavior, self-harm, and even suicide (2-4). MBCT is an intervention that has been shown to reduce depression, stress and anxiety in the adult and university population; however, its duration and time demands make it difficult to implement. The available evidence of mindfulness interventions in university students is heterogeneous, with various methodological flaws, and is based on self-applied programs such as Mindful Mood Balance (MMB), without the participation of instructors. The current study aim to explore the acceptability and feasibility of an intervention based on a Mindfulness-based Cognitive Therapy (MBCT) program with training in mindfulness strategies for 8 weeks. The adapted MBCT intervention will consist of eight weekly group sessions of 1 hour and 30 minutes, led by a certified instructor, to address the depressive and anxiety symptoms in the university population. In addition, the intervention will be complemented with the inclusion of audiovisual material, aimed at guiding self-applied daily exercises.