Fort Belvoir

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Researchers are studying the effects of art therapy on emotional expression, regulation, and brain function in military service members with posttraumatic stress symptoms. This research focuses on understanding how art therapy influences emotional well-being and neurological systems in this population. Participants will be service members or veterans with significant posttraumatic stress symptoms, and the study includes brain imaging to explore these effects. Participants will attend eleven sessions over six to eight months. The first and tenth sessions involve interviews, self-assessment questionnaires, and MRI scans during which participants view neutral and negative images. Sessions two through nine consist of one-hour art therapy sessions guided by a certified art therapist, who supports participants in creating art and discussing their feelings and experiences. The final session includes some questionnaires and a virtual qualitative interview conducted three months after the tenth visit. Throughout the study, participants will complete questionnaires to assess symptoms, experiences, and personality traits. MRI scans will measure brain activity related to emotional processing at the start and near the end of the study. Researchers will monitor changes in emotional regulation and neurological function. The total duration of participation is about six to eight months, with follow-up interviews to understand long-term effects. Safety monitoring includes awareness of potential emotional distress during therapy or assessments.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled adaptive platform trial to study treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This trial focuses on evaluating the safety, tolerability, and effectiveness of multiple potential drug treatments using a shared control group to compare interventions. One group in this trial is studying fluoxetine, a medication used to treat PTSD symptoms. Participants in the fluoxetine group will be randomly assigned to receive either fluoxetine or a placebo in a 5:3 ratio during a 12-week treatment period. Fluoxetine dosing starts at 10 mg daily for one week, then increases to 20 mg daily for two weeks, followed by 40 mg daily for two weeks, and then 60 mg daily for the remainder of the trial. Dose reductions are allowed once if needed for tolerability, but doses will not be increased after a reduction. The study includes a 30-day screening period before treatment and a 4-week safety follow-up after treatment. Participants will undergo evaluations including the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) to measure PTSD symptoms and the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor suicidal thoughts or behaviors. These measures will be assessed at the end of the 12-week treatment or at early termination. Safety and tolerability will be closely monitored throughout the study. Total participation involves screening, treatment, and follow-up lasting approximately 16 weeks.

Researchers are conducting a Phase 2 adaptive platform trial to evaluate several potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This part of the trial focuses on studying daridorexant, assessing its safety and effectiveness compared to a placebo. The study design allows participants to be randomly assigned to different treatment groups, sharing a common placebo control for comparison. Participants who qualify under the Master Protocol undergo a 30-day screening period before being randomized into the daridorexant group or placebo group in a 5:3 ratio. Those receiving daridorexant take a 50 mg dose once daily, at least two hours after their last meal and within 30 minutes of going to bed. The treatment phase lasts 12 weeks, followed by a 4-week safety follow-up to monitor participants after treatment. Throughout the study, researchers measure changes in PTSD symptoms using the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) over 12 weeks. They also track any new or worsening suicidal thoughts or behaviors via the Columbia Suicide Severity Rating Scale (C-SSRS). The total study participation spans about 16 weeks, including screening, treatment, and safety monitoring periods.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled trial to evaluate multiple potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This adaptive platform trial allows multiple treatment groups to be compared to a shared placebo control group, enabling efficient assessment of safety, tolerability, and effectiveness. The study also incorporates biomarker assessments to help define future participant groups based on biological markers, allowing a multi-stage testing approach including both non-biomarker and biomarker-defined cohorts. Participants will undergo a 30-day screening period, followed by a 12-week treatment period, and then a 4-week safety follow-up. The study includes up to five treatment arms, each testing a different drug or its matching placebo. Treatments include Fluoxetine hydrochloride, Vilazodone hydrochloride, Daridorexant, and SLS-002 administered according to specific dosing schedules ranging from daily oral doses to twice-weekly intranasal sprays. Dose adjustments for tolerability are permitted within predefined limits. New treatment cohorts can be added during the trial, and safety monitoring is overseen by an independent board. Throughout the study, participants will be assessed for changes in PTSD symptoms using standardized clinical scales and monitored for any new or worsening suicidal thoughts or behaviors. Procedures include blood draws, MRI scans, and various clinical evaluations. Data will be reviewed regularly to decide on continuing or stopping treatment arms. The total participant involvement spans approximately 16 weeks, including screening, treatment, and follow-up, with ongoing safety and biomarker analyses to guide future research directions.

Researchers are evaluating the safety and effectiveness of Lacripep, an eyedrop medication, as a treatment for healing superficial corneal injuries that occur after Photorefractive keratectomy (PRK) or trauma. The study focuses on active-duty military service members or their dependents to determine if Lacripep can help speed up corneal wound healing and visual recovery. This is a Phase 2 clinical trial assessing Lacripep's role in ocular surface healing. Participants will receive 0.00025% Lacripep ophthalmic solution in one eye and a placebo in the other eye simultaneously. The study involves bilateral PRK surgery followed by treatment with the eyedrops. Corneal epithelial thickness will be measured at various time points: 4 and 7 days post-surgery, then at 1, 3, and 6 months to evaluate healing progress. During the study, participants will be monitored through follow-up visits for up to six months after surgery. Researchers will assess corneal healing by measuring epithelial thickness and observing ocular surface health. The study includes safety evaluations and careful tracking of visual acuity and any adverse effects. Participation requires multiple postoperative assessments to understand Lacripep's impact on corneal wound healing over time.

Researchers are evaluating the effectiveness and safety of osimertinib tablets combined with Datopotamab Deruxtecan (Dato-DXd) intravenous infusion compared to osimertinib alone as a first treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Ex19del and/or L858R). This global Phase III, open-label, randomized study focuses on participants who have not received prior therapy for advanced disease. The goal is to show that the combination therapy improves progression-free survival compared to osimertinib alone. Participants will be randomly assigned to receive either osimertinib 80 mg orally once daily or osimertinib plus Dato-DXd at 6 mg/kg given by intravenous infusion every three weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or other reasons require stopping. Visits for assessments will occur every three weeks during treatment. For those on osimertinib alone or who discontinued Dato-DXd but continue osimertinib, visits will be every six weeks from cycle 7 to cycle 17, then every 12 weeks until disease progression or treatment stops. Participants receiving both drugs will have visits every three weeks. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their condition and treatment effects. Researchers will track progression-free survival through independent review about three years after the first participant is enrolled. The study is expected to last about eight years, with ongoing monitoring of safety and treatment tolerance throughout. Participants must attend scheduled visits for evaluations and treatment administration as outlined in the study plan.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with Rilvegostomig or Rilvegostomig alone compared to Pembrolizumab alone as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Participants must have high PD-L1 expression (tumor cells 50% or greater) and no actionable genetic changes. This Phase III, randomized, open-label global study focuses on this specific group of lung cancer patients without known targetable mutations. The trial includes three treatment groups: one receiving Dato-DXd plus Rilvegostomig intravenously, one receiving Rilvegostomig alone intravenously, and one receiving Pembrolizumab alone intravenously. Treatments are given as first-line therapy, meaning participants have not received prior systemic treatment for advanced disease. The study compares these treatments to assess their effect on cancer progression and survival. Participants will be closely monitored throughout the study, which includes assessments of progression-free survival over about four years and overall survival over about six years. Researchers will collect tumor samples to confirm PD-L1 and TROP2 status, perform scans to measure tumor response, and evaluate organ function and performance status. Safety and side effects will be tracked to understand treatment tolerability. The entire participation duration may extend up to several years to capture long-term outcomes.

Researchers are evaluating the safety, effectiveness, and tolerability of two repetitive transcranial magnetic stimulation (rTMS) treatments targeting the dorsolateral prefrontal cortex to reduce depression symptoms in U.S. military service members and veterans with a history of concussion or mild traumatic brain injury (TBI). This randomized, double-blind, Bayesian adaptive trial focuses on current and former service members who experience depressive symptoms following concussion, a condition common in this population. Participants will receive either individualized connectome targeted accelerated intermittent Theta Burst Stimulation (aiTBS) or scalp-targeted aiTBS using active rTMS devices, with a sham rTMS group for comparison. The study involves multiple sessions where these treatments are applied to assess their therapeutic potential for depression related to concussion. During the study, participants will be monitored through clinical assessments including the Montgomery-Asberg Depression Rating Scale (MADRS) to measure changes in depression severity from baseline to post-intervention and up to six months follow-up. Researchers will track treatment response, remission duration, and adverse events. The total time commitment includes baseline screening, treatment sessions, and follow-up visits to evaluate long-term outcomes and safety.