Fort Belvoir

Researchers are evaluating the efficacy and safety 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 progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations 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. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are studying how art therapy affects emotional expression and regulation in military service members with posttraumatic stress symptoms. The study aims to understand the neurological systems involved by using brain scans and self-assessment questionnaires. This research is conducted within the Military Health System where art therapy is a common treatment but lacks thorough scientific evaluation. Participants will attend a total of eleven sessions over six to eight months. The first session includes an interview, self-assessment questionnaires, and a brain MRI scan while viewing neutral and negative images. Then, participants take part in eight one-hour individual art therapy sessions with a certified art therapist. The tenth session repeats the questionnaires and MRI scan, and the final session is a virtual interview conducted three months after the tenth visit. Throughout the study, participants will complete various questionnaires measuring symptoms and traits related to posttraumatic stress, anxiety, stress, and emotional regulation. Brain activity during tasks will be assessed through functional neuroimaging. The research also monitors potential emotional distress during sessions and collects qualitative feedback. Overall participation lasts up to eight months with follow-up to evaluate lasting effects.

Researchers are evaluating the safety and effectiveness of Lacripep, an investigational eyedrop medication, for repairing superficial corneal injuries such as those caused by Photorefractive keratectomy PRK, eye trauma, or surgery. This study focuses on active-duty military service members and their dependents to understand if Lacripep can help heal the corneal surface and speed up visual recovery after injury. Participants will receive Lacripep in one eye and a placebo in the other eye simultaneously after undergoing bilateral PRK surgery. The study will follow participants for six months postoperatively to assess the medications effects on corneal healing and ocular surface health. During the study, participants will have their corneal epithelial thickness measured at 4 and 7 days after surgery, then again at 1, 3, and 6 months. Safety monitoring will occur from enrollment through the six-month treatment period. Participants must be able to attend follow-up visits and will be monitored for both healing progress and any side effects related to the treatment.

Researchers are evaluating the effectiveness and safety of palazestrant combined with ribociclib compared to letrozole combined with ribociclib in adults with advanced breast cancer that is estrogen receptor positive ER and human epidermal growth factor receptor 2 negative HER2-. This phase 3 clinical trial includes women and men who have not yet received systemic treatment for their advanced breast cancer, aiming to find improved first-line treatment options. Participants are randomly assigned to one of two groups one group receives palazestrant 90 mg daily with ribociclib 600 mg daily taken on days 1-21 of each 28-day cycle plus a placebo matching letrozole the other group receives letrozole 2.5 mg daily with ribociclib 600 mg daily plus a placebo matching palazestrant. Treatments are given in repeating 28-day cycles. The study is double-blind and active-controlled, meaning neither participants nor researchers know who receives which treatment, and both groups receive active drugs. During the trial, participants will be monitored regularly for disease progression and survival over approximately 3.5 to 5.5 years. Assessments include tumor response evaluations, safety and tolerability checks, pharmacokinetic blood tests every 28 days, and patient-reported health outcomes. The primary outcome is progression-free survival, measuring the time from randomization until disease worsens or death. Safety monitoring continues for up to 42 days after treatment ends, with the study lasting until 2032.

Researchers are evaluating the safety and effectiveness of combining osimertinib tablets with Datopotamab Deruxtecan intravenous infusion compared to using osimertinib tablets alone as a first treatment for participants with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific EGFR mutations Ex19del andor L858R. This global Phase III, open-label, randomized study targets participants who have not yet received treatment for advanced disease and aims to assess how well this combination works and how safe it is over an estimated 8-year event-driven study duration. Participants will be randomly assigned to one of two groups one will receive osimertinib 80 mg orally once daily combined with Datopotamab Deruxtecan 6 mgkg by intravenous infusion every three weeks, while the other will receive osimertinib 80 mg orally once daily alone. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. During treatment, visits occur every three weeks. For those receiving osimertinib alone or who stop Datopotamab Deruxtecan but remain on osimertinib, visits become every six weeks from cycle 7 to cycle 17 and then every twelve weeks until disease progression or stopping treatment. Participants will undergo regular assessments including scans and tests to monitor disease status and treatment effects as per the study schedule. Researchers will measure progression-free survival, overall survival, response rates, and other outcomes related to the cancer and treatment effects. Safety and drug levels will also be monitored. Participants can expect frequent visits and evaluations throughout the study, lasting up to about eight years or until specific stopping criteria are met.

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.

This research aims to evaluate the safety, effectiveness, and tolerability of two repetitive transcranial magnetic stimulation rTMS protocols targeting the dorsolateral prefrontal cortex to reduce depression symptoms in U.S. military members and veterans with a history of concussion or mild traumatic brain injury. The study uses a randomized, double-blind, Bayesian adaptive design to compare individualized connectome targeted accelerated intermittent Theta Burst Stimulation and scalp-targeted stimulation in this specific population. Participants are assigned randomly to one of three groups active rTMS with individualized connectome targeting, active rTMS with resting state functional MRI-based targeting, or a sham placebo rTMS group. These treatments are delivered as device-based brain stimulation therapies designed to assess their impact on depressive symptoms. The study includes an initial treatment phase followed by post-intervention assessments and a 6-month follow-up period. During the study, participants will undergo evaluations using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms from baseline through post-intervention and at 6 months. Additional assessments include self-reported depression scales, quality of life related to brain injury, PTSD symptoms, and brain connectivity via MRI scans. Researchers will monitor treatment compliance, adverse events, and overall safety throughout the trial, which lasts up to 6 months after final treatment.

Researchers are evaluating the safety and effectiveness of sonesitatug vedotin combined with capecitabine, with or without rilvegostomig, as a first-line treatment for people with Claudin18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma. This Phase III study also assesses the performance of investigational in vitro diagnostics used to identify eligible patients. The trial includes two groups based on PD-L1 status and eligibility for immune checkpoint inhibitor therapy. Participants will be assigned to one of several treatment groups. Cohort 1 includes participants who are PD-L1 positive and eligible for immune checkpoint inhibitors, receiving sonesitatug vedotin, rilvegostomig, and capecitabine. Cohort 2 includes PD-L1 negative or ineligible participants receiving sonesitatug vedotin with capecitabine. Other treatment arms involve combinations including nivolumab, zolbetuximab, and chemotherapy regimens such as CAPOX or FOLFOX. During the study, participants will be monitored for up to approximately five years to assess progression-free survival and overall survival. Researchers will also evaluate response rates, duration of response, pharmacokinetics, immunogenicity, safety, and tolerability. Participants will undergo regular assessments, including imaging to measure tumors and laboratory tests to monitor health and treatment effects.