Palm Bay

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 evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the effectiveness of NBI-1065845 compared to a placebo as an additional treatment to delay the return of depressive symptoms in adults with Major Depressive Disorder (MDD). This phase 3 study focuses on participants who have had moderate to severe recurrent MDD or persistent depressive disorder and have not responded adequately to oral antidepressant treatments. The goal is to maintain the positive effects of treatment and prevent relapse over a period of up to approximately 32 months. Participants receive either the study drug NBI-1065845 or a placebo in oral tablet form, both given alongside their ongoing oral antidepressant medications. They must continue their current antidepressant treatment at the same dose and frequency throughout the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatments. During the study, participants are monitored from the time of randomization until relapse or the study end, which may last up to 32 months. Researchers assess the time it takes for depressive symptoms to return, using measures such as the Hamilton Depression Rating Scale. Participants are expected to comply with all study procedures and restrictions, and safety monitoring is conducted throughout the study period.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are evaluating the effectiveness and safety of BMS-986489, a fixed-dose combination of atigotatug and nivolumab, compared to durvalumab in participants with limited-stage small-cell lung cancer (LS-SCLC). This Phase 2, open-label, randomized study focuses on consolidation therapy following standard chemoradiotherapy in participants without disease progression. Atigotatug is a novel antibody targeting fuc-GM1 on tumor cells, and when combined with nivolumab, an immune checkpoint inhibitor, it may enhance antitumor effects. Participants will be randomly assigned to receive either BMS-986489 or durvalumab as consolidation therapy. Both treatments are given as intravenous infusions once every 4 weeks for up to 2 years. Before randomization, participants must have completed concurrent chemotherapy (including platinum and etoposide) and radiotherapy without progression. Prophylactic cranial irradiation may be given before starting study treatment, following institutional guidelines. During the study, participants will be monitored regularly for overall survival up to 5 years from randomization, with assessments every 8 to 12 weeks depending on treatment status. Researchers will evaluate safety and efficacy through clinical examinations, imaging scans, laboratory tests, and adverse event monitoring. Participants are expected to follow contraceptive guidelines and maintain follow-up visits as outlined in the protocol.

Researchers are conducting a Phase 3, randomized, double-blind, multiregional study to compare two treatments for metastatic non-small cell lung cancer (NSCLC). The study includes two separate groups based on NSCLC histology: squamous and non-squamous types. The main goals are to evaluate overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab combined with platinum-doublet chemotherapy or pembrolizumab combined with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. Each histology group will be analyzed separately, with about 600 patients in the squamous group and 1000 in the non-squamous group. During the study, participants will be monitored for survival outcomes over approximately 3 to 4 years. Researchers will assess tumor response and safety through regular evaluations. Eligibility requires confirmed metastatic NSCLC, with specific tumor measurements and no prior systemic treatment for metastatic disease. This study aims to provide important information on these first-line treatment options for metastatic NSCLC.

Researchers are evaluating the safety and effectiveness of an investigational drug called ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with PD-L1-positive recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This study includes both Phase 2 and Phase 3 parts. Ficerafusp alfa targets two cancer-related proteins, EGFR and TGF-beta, which play roles in tumor growth and spread. The goal is to find the best dose and then compare treatment outcomes between groups. In Phase 2, participants will be randomly assigned to one of three groups: ficerafusp alfa 1500 mg weekly plus pembrolizumab every three weeks, ficerafusp alfa 750 mg weekly plus pembrolizumab every three weeks, or placebo weekly plus pembrolizumab every three weeks. Phase 3 will randomize participants to the selected ficerafusp alfa dose plus pembrolizumab or placebo plus pembrolizumab. Treatments will continue as scheduled, and safety, tolerability, and treatment responses will be closely monitored throughout. Participants will undergo assessments including scans to measure tumor response using RECIST 1.1 criteria, safety evaluations for side effects, and survival tracking. Safety monitoring includes checking for treatment-related adverse events up to 30 days after treatment ends and serious events up to 90 days afterward. The study will follow participants for approximately one year in Phase 2 and up to three years in Phase 3 to evaluate treatment effectiveness and overall survival.

This research aims to evaluate the long-term safety and tolerability of NBI-1065845 when added to ongoing antidepressant treatment in adults diagnosed with Major Depressive Disorder (MDD). It focuses on participants who have experienced moderate or severe recurrent MDD or persistent depressive disorder and who have not responded adequately to oral antidepressants during their current depressive episode. This is a Phase 3, open-label study designed to monitor the effects of this adjunctive treatment over an extended period. Participants will receive NBI-1065845 tablets alongside their current oral antidepressant therapy. The study will observe treatment effects and monitor any adverse events that emerge during the course of therapy. There is no mention of a comparator or placebo group, indicating all enrolled individuals will be treated with NBI-1065845 in addition to their existing medication. The treatment and observation period extends through 52 weeks, allowing for comprehensive long-term safety assessment. During the study, participants will be regularly evaluated for treatment-emergent adverse events from the start through week 52. Researchers will track safety and tolerability through clinical assessments and monitoring. Participants must be willing and able to follow all study procedures and restrictions as determined by the investigators. The overall duration and detailed assessments ensure thorough monitoring of how well participants tolerate the adjunctive treatment over the course of one year.