Bala Cynwyd

Researchers are evaluating new treatment options for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the inner lining of the bladder but has not spread to the muscle or beyond. This includes carcinoma in situ (CIS), a flat form of bladder cancer limited to the bladder's surface. The study aims to find out if adding intismeran autogene, an immune system-targeting treatment, to the standard Bacillus Calmette-Guerin (BCG) therapy can improve outcomes for people with HR NMIBC by helping the immune system attack the cancer more effectively. Participants are assigned to different groups. One group receives both intismeran autogene by intramuscular injection every three weeks for nine doses along with BCG treatment given once weekly for six weeks, followed by additional weekly doses at later weeks. Another group receives BCG alone on the same schedule, while a third group receives only intismeran autogene. The study compares these treatments to see if the combination improves survival without cancer growth, spread, or return. During the study, participants will be monitored for up to approximately five years to track event-free survival, recurrence-free survival, overall survival, and other outcomes. Researchers will also evaluate adverse events and treatment tolerability. Follow-up includes assessments at regular intervals to observe disease status and safety. The total participation time may last several years to gather long-term data on treatment effects.

Researchers are studying PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer, including those whose cancer has returned or not responded to previous treatments. The trial aims to evaluate the safety and tolerability of PRL-02 depot alone or combined with enzalutamide, as well as to determine the appropriate dose. This Phase 1 study is sponsored by Astellas Pharma Global Development, Inc. and focuses on men with metastatic or biochemical relapse forms of prostate cancer. Participants will be divided into groups receiving different doses of PRL-02 depot injected into a muscle every 12 weeks. They will also take daily oral doses of either dexamethasone, prednisone, or enzalutamide depending on their study group and prior treatments. The study has two parts: dose escalation with small groups receiving increasing doses, and dose expansion involving men previously treated with specific hormone therapies. During the trial, men will visit the clinic multiple times for health checks, scans, and blood tests to monitor side effects, disease progression, and testosterone suppression. After the final visit, those whose cancer has not worsened will continue to have periodic health assessments and scans. The main outcomes include tracking dose limiting toxicities and adverse events over up to four years, along with detailed pharmacokinetic and response measurements.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy (HRT) compared to alternative treatments, abiraterone acetate or enzalutamide, in adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one next-generation hormonal agent (NHA). The study aims to determine if opevesostat improves the time participants live without their cancer worsening on scans, considering both those with and without certain androgen receptor mutations. Overall survival was also added as a secondary outcome to be assessed over a longer period. Participants are randomly assigned to one of two treatment groups. One group receives oral opevesostat twice daily along with daily dexamethasone and fludrocortisone acetate, continuing until their disease progresses. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone acetate plus prednisone or enzalutamide daily, also until disease progression. The study is open-label, meaning both researchers and participants know which treatment is given. During the study, participants will have regular assessments including imaging scans to monitor cancer progression, blood tests, and questionnaires evaluating quality of life and symptoms. Researchers will track the time until cancer worsens on imaging, overall survival, response rates, pain progression, and side effects. These evaluations may continue for up to approximately 82 months. Safety monitoring and treatment adherence will be followed throughout the study period.

Researchers are evaluating pasritamig (JNJ-78278343), a T cell redirecting agent targeting human kallikrein 2, combined with best supportive care (BSC) for men with metastatic castration-resistant prostate cancer (mCRPC). This advanced cancer stage has spread beyond the prostate and no longer responds to hormone treatments. The study compares pasritamig plus BSC to a placebo plus BSC to assess overall survival in patients who have exhausted other life-prolonging therapies. Participants receive pasritamig or placebo through intravenous infusions starting with step-up doses on Cycle 1 Day 1 and Day 8, followed by the target dose on Day 15. Subsequent doses occur every 6 weeks in 6-week cycles, except the first cycle which lasts 8 weeks. All participants may receive best supportive care, including palliative radiation, steroids, pain medications, bone agents, and procedures, as determined by their doctors. Treatment continues until disease progression, intolerable side effects, death, withdrawal, or study end. During the study, participants undergo regular assessments to monitor overall survival and other outcomes like progression-free survival, symptom progression, skeletal events, pain, fatigue, and adverse events. These evaluations may include imaging, laboratory tests, and quality of life questionnaires over approximately 2 years and 8 months. Safety and treatment effects will be closely followed throughout the trial.

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time without disease worsening as seen on scans, compared to docetaxel alone, in men with metastatic castrate-resistant prostate cancer (mCRPC). This cancer grows despite low male hormone levels, and the study focuses on improving radiographic progression-free survival. The trial is a phase 3, randomized, open-label study sponsored by Janssen Research & Development, LLC. Participants are randomly assigned to one of two groups: one receives pasritamig plus docetaxel until disease progression or study end, and the other receives docetaxel along with prednisone. Treatments continue until confirmed radiographic progression or other protocol criteria are met. The study compares these two approaches to assess their impact on disease progression and overall outcomes. During the study, participants will be monitored with scans and assessments to measure progression-free survival up to about 1 year and 10 months. Additional outcomes, including overall survival, symptom progression, response rates, prostate-specific antigen (PSA) levels, quality of life, and safety, will be tracked for up to approximately 4 years and 5 months. Researchers will evaluate adverse events, laboratory results, pain, and health-related quality of life using various questionnaires throughout the study.

Glaucoma is the second most common cause of blindness worldwide, after cataracts. This research evaluates the safety and effectiveness of the XEN63 gel stent implanted using two surgical methods: ab interno (inside the eye) and ab externo (outside the eye). The study focuses on measuring eye pressure and monitoring any adverse events in adults with glaucoma that is uncontrolled by medication or previous surgeries. Participants will receive the XEN63 gel stent implanted on Day 1, either through the ab interno or ab externo approach, depending on their assigned group. Each participant will be followed for 12 months to observe how well the device controls their intraocular pressure and to track any side effects. This study is conducted at multiple sites across the United States. During the study, participants will attend regular visits at a hospital or clinic where medical assessments and eye examinations will be performed to monitor the gel stent’s effect on glaucoma. Researchers will measure the percentage of participants achieving at least a 20% reduction in eye pressure while using the same or fewer medications, as well as record any adverse events over the 12-month period.

This trial investigates treatments for high-risk non-muscle-invasive bladder cancer in participants who have previously received Bacillus Calmette-Gue9rin (BCG) treatment. It compares disease-free survival between participants treated with TAR-210, a drug delivered inside the bladder, and those receiving intravesical chemotherapy chosen by their doctor. The study focuses on participants with certain FGFR gene alterations and aims to evaluate the length of time participants remain free of cancer signs or symptoms after treatment. Participants are randomly assigned to one of two groups. Group A receives TAR-210 inserted into the bladder on Day 1 and continues this treatment for about two years. Group B receives intravesical chemotherapy with either mitomycin C or gemcitabine, given once weekly for 4 to 6 doses as induction therapy, followed by monthly maintenance doses for up to one year, with an optional second year of maintenance at the doctor's discretion. Treatments are delivered directly into the bladder through a catheter. During the study, participants will be monitored regularly for up to five years to measure outcomes such as disease-free survival, recurrence-free survival, time to disease worsening, and overall survival. Assessments include safety evaluations using standard criteria, laboratory tests, vital sign checks, and quality-of-life questionnaires at multiple scheduled time points. Researchers will also track adverse events and changes in health status to assess the impact of treatments over time.

The trial investigates intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC) in adults with a specific FGFR mutation or fusion. It aims to compare disease-free survival between two treatments: TAR-210, a drug delivery system for erdafitinib, and intravesical chemotherapy chosen by the investigator. This phase 3 randomized study is sponsored by Janssen Research & Development, LLC and addresses the treatment of bladder cancer with susceptible FGFR alterations. Participants are randomly assigned to one of two groups. Group A will have the TAR-210 device inserted into the bladder every 12 weeks for about one year, with each device removed after 12 weeks. Group B will receive intravesical chemotherapy using either mitomycin C or gemcitabine, given weekly for 4 to 6 doses, followed by a maintenance phase lasting at least 6 months and up to one year. A substudy follows a similar design with Group A receiving TAR-210 and Group B receiving mitomycin C. Participants will undergo multiple cystoscopies and a transurethral resection of bladder tumor (TURBT) procedure to assess recurrence or progression. Researchers will monitor disease-free survival over approximately 4 years and 2 months, along with other outcomes including time to next treatment, progression-free survival, quality of life questionnaires, and adverse events. Safety and overall survival are also tracked throughout the study period, with follow-up evaluations at regular intervals.

Researchers are evaluating the safety and effectiveness of NEXAGON4 (lufepirsen ophthalmic gel) in people with persistent corneal epithelial defects (PCED), a condition where the corneal surface does not heal properly. This randomized, double-masked, vehicle-controlled study aims to understand how well NEXAGON works in treating PCED and its durability after treatment. This Phase 2 trial is sponsored by Glaukos Corporation and is conducted at multiple centers. Participants will be randomly assigned to receive one of three treatments applied topically to the eye once a week for 4 to 8 weeks: a high dose of lufepirsen, a low dose of lufepirsen (available only at EU sites), or a vehicle gel without the active drug. After the treatment period, a 4-week follow-up will monitor the condition. If the corneal defect does not heal or the healing is not maintained for 28 days, participants may enter an open-label treatment phase with NEXAGON for an additional 8 weeks. During the study, participants will undergo screening to confirm eligibility, receive weekly treatment applications, and be monitored for safety and healing progress. Researchers will assess corneal re-epithelialization and its durability as the main outcome. The total study participation includes the screening, up to 8 weeks of treatment, 4 weeks of follow-up, and possibly an 8-week open-label extension. Safety, efficacy, and healing durability will be closely observed throughout these periods.

This research investigates a treatment for adults with muscle-invasive bladder cancer, a condition where cancer has grown into the muscle wall of the bladder. Standard care involves chemotherapy followed by surgery to remove the bladder, which can cause significant long-term changes. This trial studies enfortumab vedotin combined with pembrolizumab as a possible alternative for people who are able to have surgery but may benefit from preserving their bladder. The goal is to see how many participants keep responding well to this treatment and retain their bladder after two years. Participants will receive intravenous infusions of enfortumab vedotin on days 1 and 8 of each 21-day cycle, along with pembrolizumab on day 1 of every cycle. Treatment continues unless the cancer worsens after 9 cycles, side effects prevent continuation, or other treatments begin. If cancer progresses, options such as bladder surgery, radiotherapy, or chemotherapy may be considered. This study is open-label, single-arm, and phase 2, focusing on bladder preservation during treatment. Throughout the study, participants will have safety checks at each visit, including tumor assessments at some visits. After stopping study treatment, participants will attend follow-up visits for health evaluations and medical problem monitoring. Scans will be done every 12 weeks for the first two years, then every 24 weeks for up to five years unless cancer worsens. After progression, participants will have health checks by telephone every three months. The study includes evaluations of clinical response, bladder-intact survival, overall survival, and adverse events.