St. Louis Park

Researchers are evaluating a new medicine called ifinatamab deruxtecan (I-DXd) for treating men with metastatic castration-resistant prostate cancer (mCRPC). The study aims to find out if people receiving I-DXd live longer overall and have longer periods without cancer growth or spread compared to those receiving chemotherapy. This is a Phase 3, open-label trial sponsored by Merck Sharp & Dohme LLC. Participants in the study will be randomly assigned to receive either I-DXd at a dose of 12 mg/kg every 3 weeks or a combination of docetaxel chemotherapy (75 mg/m² every 3 weeks) with daily prednisone. I-DXd is given by intravenous infusion every 3 weeks until the disease progresses or side effects prevent continued treatment. Premedication is given before I-DXd to help prevent nausea and vomiting. During the study, participants will be closely monitored for overall survival and radiographic progression-free survival for up to about 36 months. Researchers will also assess several other outcomes including response rates, time to progression, pain progression, prostate-specific antigen changes, and side effects. Safety and treatment tolerability will be tracked throughout, and participants’ health will be regularly evaluated with scans and other tests.

This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation (MESI). This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments: KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity (BCVA) over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation (MESI). The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments: an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have previously received at least one line of systemic anticancer therapy. This proof-of-concept Phase 2 study includes multiple cancer types such as melanoma, head and neck cancer, gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The study also examines the relationship between HER3 protein expression in tumors and the treatment's efficacy. Participants will receive HER3-DXd, an intravenous infusion given at a dose of 5.6 mg/kg every three weeks (Q3W). This monotherapy treatment continues through repeated 21-day cycles. The study is open-label and multicohort, allowing enrollment of different tumor types in separate groups. HER3-DXd pharmacokinetics and safety will also be monitored throughout the study. During the trial, participants will undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, and safety assessments. Researchers will assess objective response rates, progression-free survival, overall survival, and other clinical outcomes over approximately 27 months. Pharmacokinetic data will be collected at multiple timepoints during treatment cycles. The study will also track treatment-emergent adverse events and monitor participants until disease progression, withdrawal, or death.

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not previously received treatment. The study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate, and whether it is better in progression-free survival according to specific criteria. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either nemtabrutinib or the investigator’s choice of ibrutinib or acalabrutinib, all given orally at specified doses. Treatments continue until the disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. This study compares these treatments directly to assess their effects in first-line therapy for CLL/SLL. During the trial, participants will be regularly monitored for treatment response and disease progression using standardized criteria assessed by independent reviewers, over periods up to approximately 33 months for response and up to 104 months for progression-free survival. Researchers will also evaluate overall survival, duration of response, adverse events, and reasons for treatment discontinuation. Careful safety monitoring will be conducted throughout the study, which may last up to several years from treatment start.

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 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.

Researchers are evaluating whether adding tucatinib to trastuzumab and mFOLFOX6 works better than the current standard treatments for people with HER2 positive metastatic colorectal cancer. This study focuses on participants whose cancer has spread or cannot be removed by surgery. The trial also monitors side effects that might occur from taking these drug combinations. Participants are randomly assigned to one of two groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every three weeks and mFOLFOX6 chemotherapy every two weeks. The other group receives standard care, which includes mFOLFOX6 alone or combined with bevacizumab or cetuximab given by intravenous infusion. The study treatments continue as per the assigned schedule. During the study, participants undergo regular scans and evaluations to measure progression-free survival and other outcomes up to approximately three years. Researchers also assess overall survival, response rates, duration of response, quality of life, and side effects for up to about six years. Safety monitoring continues for around one year after the last treatment. Participants are closely followed to understand the impact of these treatments on their cancer and well-being.