A Phase 3 Multi-center Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
To evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH compared with placebo as measured by the OHSA composite score over a double-blind, RW period of 8 weeks following an OL period of 12 weeks.This study includes 4 periods: Screening, OL, RW, and Long-Term Treatment Extension (LTE). Screening is approximately 14 days. The OL and RW periods of the study are a Phase 3, multi-center, RW study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. Approximately 102 participants will be enrolled such that at least 72 participants continue into the RW period. The LTE period is to evaluate the safety and tolerability of ampreloxetine in participants with MSA and symptomatic nOH over 104 weeks.
A Phase 3 Multicenter Randomized Open-Label Trial of Epcoritamab in Combination with R-CHOP compared to R-CHOP in Subjects with High-Risk Diffuse Large B-Cell Lymphoma
The purpose of this trial is to evaluate whether the addition of epcoritamab to R-CHOPcan improve outcomes versus R-CHOP alone in first-line therapy of high-risk DLBCLpatients.
A Phase 3 Open-Label Randomized Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safetyof DZD9008 versus platinum-based doublet chemotherapy in participants with locally advancedor metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have notreceived prior systemic therapy in advanced stage.
A Phase 3 Randomized Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with BCG in Participants with HR NMIBC that is either Persistent or Recurrent Following BCG Induction or that is Na ve to BCG Treatment (KEYNOTE-676)
This is a randomized, comparator-controlled, parallel-group, multi-site, open-label study of pembrolizumab in combination with BCG in participants with HR NMIBC that is persistent or recurrent following BCG induction.Specific procedures to be performed during the study, as well as their prescribed times and associated visit windows, are outlined in the Schedule of Activities (SoA), Section 1.3.Details of each procedure are provided in Section 8. Approximately 550 participants with HR NMIBC that have persistent or recurrent disease after receiving adequate BCG induction (Section 5.1) will be randomized in a 1:1 ratio to receive BCG + pembrolizumab (Arm 1) or BCG alone (Arm 2). Participants with persistent T1 disease after induction BCG are not eligible. Participants will be stratified based on the presence or absence of CIS in tissue submitted during screening, PD-L1 combined positive score (CPS) =10 or 6 months to =12 months or recurrent NMIBC at >12 months to =24 months). To ensure approximately 368 of the planned 550 participants enrolled in the study have CIS, enrollment of non-CIS participants will be capped at approximately 182.
A Phase 3 Randomized Double-blind Matching Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
This is a Phase 3, randomized, placebo-controlled, parallel-group, multi-site, double-blind (with in-house blinding) study of pembrolizumab + CRT versus placebo + CRT in participants with MIBC (T2-T4aN0M0) who are deemed eligible for and have elected to be treated with CRT (Section 5.1).Approximately 636 participants with previously untreated MIBC who have elected to be treated with CRT will be randomized. A biopsy demonstrating MIBC must have been performed within 60 days prior to enrolling into the study (signing the ICF), and tumor tissue must be available for central pathology review (to confirm histology and the presence of muscle invasion, and for evaluation of PD-L1 status) prior to randomization. A maximal TURBT to remove all resectable/visible disease must occur prior to randomization; this may have occurred prior to enrollment (within 60 days prior to signing the ICF), or may be performed during Screening prior to randomization after confirmation of eligibility. All participants will also undergo baseline screening imaging (CTU or MRU of the abdomen and pelvis and a CT of the chest) for clinical staging (reviewed by BICR) prior to randomization to confirm eligibility. The radiation treatment plan must also be submitted for central review prior to randomization.Eligible participants will be randomized in a 1:1 ratio to receive CRT with either pembrolizumab (Arm A) or placebo (Arm B). Randomization will be stratified based on the following factors:- ECOG PS of 0 & 1 versus 2- PD-L1 CPS
A Phase 3 Randomized Double-blind Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with Resected Stage II IIIA IIIB (N2) Non-small Cell Lung Cancer
This clinical study will evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II to IIIB (N2) NSCLC.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POETYK-SLE-2)
The 52-week double-blinded study is divided into 3 separate periods that will take about 60 weeks to complete:• Screening Period (4 weeks), • Treatment Period (52 weeks), and • Safety Follow-Up (4 weeks). • The Treatment Period is called a “Double-Blinded” or “Blinded” Treatment Period because neither you nor your study team will know whether you are getting deucravacitinib or placebo. There is a 50% chance of being on deucravacitinib and a 50% chance of being on placebo during this 52-week Treatment Period.Participants who complete the Treatment Period (either on deucravacitinib or placebo), may be able to enter into an optional Long-Term Extension (LTE) Period of up to 2 years (104 weeks). -
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POTEYK-SLE-1)
This is a Phase 3, randomized, parallel-arm, double-blind, PBO-controlled, multicenter 52-week clinical trial to evaluate the efficacy and safety of deucravacitinib in adult participants with active SLE while receiving stable background standard of care treatment. There is an optional 104-week open-label long-term-extension (LTE) period.
A Phase 3 Randomized Multicenter Double-Blind Placebo-Controlled Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis
This is a multicenter, global, randomized, double-blind, placebocontrolled, efficacy and safety study in Mayo Stage IV subjects with AL amyloidosis. Newly diagnosed Mayo Stage IV subjects with AL amyloidosis will be randomized in a 2:1 ratio to birtamimab or placebo. The initial first-line chemotherapy regimen must include bortezomib.
A Phase 3 Randomized Placebo-Controlled Double-Blind Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients with P53 Wild-Type Advanced or Recurrent Endometrial Carcinoma (GOG 3083)
The purpose of this research study is to further evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer.