Mayville, South Africa

A Simple Intervention to Increase Persistence on PrEP in MSM to Improve Decision Making

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC. The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI > 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no). This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.

First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Study for Subjects with Relapsed/Refractory Non-Hodgkin Lymphoma

This is a phase 1, first-in-human (FIH), open-label study to evaluate the safety of CD19 t-haNK as a single agent and the safety and preliminary efficacy of CD19 t haNK in combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities. Subjects will initially receive a single 3 week cycle of the CD19 t haNK as a single-agent regimen. Following a 1-week safety pause, subjects will then receive a 3 week cycle of CD19 t-haNK in combination with rituximab. Subjects will then undergo the first tumor assessment. Subjects with no evidence of progressive disease (PD) will be eligible to receive up to 2 additional 3 week cycles of CD19 t haNK in combination with rituximab.

Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer