Regina

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

There are very limited data on HPV vaccination among the 18 million women living with HIV (WLWH) worldwide, who face a higher risk of HPV infection and cervical cancer. This study focuses on evaluating the nonavalent HPV (9vHPV) vaccine in WLWH aged 18 to 45 in Canada, especially investigating reduced-dose schedules since the previously used quadrivalent HPV vaccine has been discontinued. The goal is to understand how different HPV vaccination strategies, including fewer doses, could help meet the World Health Organization's aim to eliminate cervical cancer globally. Participants will be randomly assigned to receive either three doses of the 9vHPV vaccine at months 0, 2, and 6, or two doses at months 0 and 6 followed by a third dose at month 12. This design follows current recommendations for WLWH and allows comparison of immune responses between the two dosing schedules. The vaccine is given as an injection to help protect against HPV types that can cause cervical cancer. During the study, participants will be followed for two years to monitor their immune response to the vaccine over time. Researchers will assess antibody levels against HPV types 16 and 18 at month 7 as the primary outcome. They will also evaluate vaccine safety, effectiveness, and participants' attitudes towards self-collected HPV samples. The findings aim to guide public health policies and improve HPV prevention for WLWH worldwide.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are evaluating the effectiveness and safety of subcutaneous amlitelimab compared with placebo in people aged 12 years and older who have moderate-to-severe atopic dermatitis (AD) and have not responded well to prior biologic or oral Janus kinase inhibitor (JAKi) therapies. This Phase 3, multinational, randomized, double-blind, placebo-controlled study includes participants who are also using background topical corticosteroids (TCS). The goal is to see how well amlitelimab works in improving AD symptoms in this group. Participants will be randomly assigned to one of three groups receiving either amlitelimab or placebo by subcutaneous injection while continuing their topical treatments, which may include corticosteroids, tacrolimus, or pimecrolimus. The total treatment period lasts up to 36 weeks during a double-blind phase. After the treatment phase, participants can choose to join a long-term safety study. The full study duration is up to 56 weeks for those not entering the safety study and up to 40 weeks for those who do, including screening, treatment, and safety follow-up periods. During the study, participants will attend up to 13 visits (or 12 for those continuing into the long-term safety study) for assessments including the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and symptom scoring. Safety monitoring and follow-up visits will track progress, side effects, and treatment response. The primary outcomes focus on improvements in skin clearing and reduction of AD severity at Week 36.

Researchers are evaluating the safety and effectiveness of SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This multinational, randomized, double-blind, placebo-controlled Phase 2 study aims to compare two doses of SAR445399 against a placebo to find the best dosing. The study involves participants who have had symptoms of hidradenitis suppurativa for at least six months and have lesions in multiple areas of their body. Participants will receive SAR445399 or a placebo as an injection. The treatment period lasts 32 weeks, split into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. The study includes 16 visits over a total duration of up to 46 weeks per participant, during which doses and responses will be carefully monitored. During the study, researchers will assess how many participants achieve significant clinical improvement in their condition by Week 16, using a measure called HiSCR75. Participants will undergo regular evaluations including physical exams and monitoring for safety. The study tracks efficacy and side effects throughout the treatment and extension periods to understand the impact of SAR445399 on hidradenitis suppurativa over time.

This research aims to evaluate the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis. This global Phase 3 study focuses on infants and toddlers with this skin condition, assessing improvements in their skin from baseline through up to 56 weeks. The study compares tapinarof cream with a vehicle cream (placebo) to better understand its effects. Participants will be randomly assigned to receive either tapinarof cream, 1%, or a vehicle cream applied once daily to affected skin areas during the initial Double-Blind period lasting up to 8 weeks. Following this, all participants may enter an Open-Label Period lasting up to 56 weeks, where tapinarof cream will be applied once daily as needed to skin lesions. This design allows researchers to monitor responses to the medication over time and assess longer-term safety and efficacy. Throughout the study, caregivers and researchers will monitor the children's skin condition using a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, focusing on the proportion of participants achieving clear or almost clear skin and a significant improvement from baseline. Safety assessments and adherence to treatment protocols will be observed. The total study duration includes both the Double-Blind and Open-Label periods, with evaluations spanning up to 56 weeks to gather comprehensive data on treatment outcomes.