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NCT ID: NCT03302234 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)

Start date: December 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.

NCT ID: NCT03301857 Completed - Clinical trials for Giant Cell Tumor of Bone

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Start date: November 13, 2017
Phase: Phase 4
Study type: Interventional

Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.

NCT ID: NCT03301597 Terminated - Clinical trials for Leukemia, Myeloid, Acute

NLA101 in Adults Receiving High Dose Chemotherapy for AML

LAUNCH
Start date: January 24, 2018
Phase: Phase 2
Study type: Interventional

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.

NCT ID: NCT03301506 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Start date: December 12, 2017
Phase: Phase 3
Study type: Interventional

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

NCT ID: NCT03301220 Active, not recruiting - Clinical trials for Smoldering Multiple Myeloma

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

NCT ID: NCT03300687 Completed - Hearing Loss Clinical Trials

First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation

Start date: May 30, 2017
Phase: Early Phase 1
Study type: Interventional

This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.

NCT ID: NCT03299660 Completed - Rectal Cancer Clinical Trials

Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

This trial is investigating the inclusion of avelumab post long-course chemo-radiotherapy in patients with resectable locally advanced rectal cancer. It is hypothesised that this may enhance the pathological and imaging response rates whilst potentially reducing the relapse rates. Participants will receive standard long course chemoradiotherapy (LCCRT) treatment with radiotherapy and 5-fluorouracil (5 FU)/Capecitabine for 6 weeks, this then followed by 4 cycles of Avelumab and then surgical resection. The trial will measure disease response just prior to surgery and participants will be followed up for a minimum of 18 months (from study entry) and up to 42 months.

NCT ID: NCT03299049 Active, not recruiting - HIV Infections Clinical Trials

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

ATLAS-2M
Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.

NCT ID: NCT03298412 Terminated - Clinical trials for High-risk Diffuse Large B-cell Lymphoma

Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT)

Start date: May 23, 2018
Phase: Phase 2
Study type: Interventional

The study will estimate the MRD-negative response rate after treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following aHSCT. The clinical hypothesis is that the MRD-negative response rate will be greater than 10%. Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.

NCT ID: NCT03297411 Recruiting - Depression Clinical Trials

Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

Start date: October 10, 2017
Phase: Phase 2
Study type: Interventional

This study will generate new information on how to optimise brain targets with ECT stimulation.