Wayne County

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.

Vitiligo is a long-term autoimmune condition where the body's immune system attacks skin cells that produce pigment, causing patches without color. This study is focused on adults with nonsegmental vitiligo, where patches appear symmetrically on both sides of the body. Researchers aim to learn how safe and tolerable the drug zasocitinib is, and how well it works for this condition. Participants will be randomly assigned to receive different doses of zasocitinib capsules or a placebo. Those initially on placebo will switch to a medium or high dose of zasocitinib after about six months. The treatment period lasts up to 52 weeks with several dosage groups including low, medium, and high doses of zasocitinib. During the study, participants will visit the clinic 11 times for assessments. Researchers will measure improvements using the Facial Vitiligo Area Scoring Index (F-VASI) and the Total Vitiligo Area Scoring Index (T-VASI). Safety, tolerability, and effectiveness will be monitored throughout the study, with the main outcome assessed at week 24. Participants will be closely followed to track treatment responses and any side effects.

Researchers are evaluating the safety and effectiveness of upadacitinib, an oral medication, in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded well or are intolerant to anti-tumor necrosis factor (TNF) therapy. HS is a painful inflammatory skin disease affecting areas such as the underarms, groin, and anal/genital regions. This phase 3 study is double-blinded, meaning neither participants nor doctors know who receives upadacitinib or placebo. The trial includes three periods and involves about 1328 participants worldwide. Participants will take oral tablets of upadacitinib or placebo once daily for 36 weeks during the first two periods. In Period 1, they are randomly assigned to receive either upadacitinib Dose A or placebo for 16 weeks. In Period 2, based on their response in Period 1, participants are divided into six groups receiving various combinations of upadacitinib doses or placebo for 20 weeks. Eligible participants continue to Period 3, a long-term extension, taking upadacitinib or placebo daily for 68 weeks, followed by a 30-day follow-up. During the study, participants will have regular outpatient visits for medical assessments, side effect monitoring, and questionnaires to track changes in disease activity and adverse events. The main outcomes include the percentage achieving clinical response (HiSCR 50) by week 16 and the number of adverse events up to week 108. Secondary outcomes measure changes in draining fistula count, symptom assessments, skin pain, odor, quality of life, and flare occurrence. This thorough monitoring helps evaluate treatment impact and safety over time.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage (stage I and II) classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments: some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Alopecia areata (AA) is a condition where the immune system attacks hair follicles causing hair loss, typically on the head and face but possibly anywhere on the body. This research aims to evaluate how safe, effective, and tolerable the drug upadacitinib is for adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled trial involving about 1500 participants worldwide with severe AA, sponsored by AbbVie. Participants will be randomly assigned to one of three groups receiving either one of two doses of upadacitinib or a placebo. In the initial period, some participants receive placebo for 24 weeks, then based on their hair loss severity measured by the Severity of Alopecia Tool (SALT) score, they may be re-randomized to continue placebo or start one of the upadacitinib doses. Those on upadacitinib continue their assigned dose. Participants who complete the first studies can join an extension study with upadacitinib treatment for up to 108 weeks. Tablets are taken orally once daily for up to 160 weeks. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in hair loss using the SALT score and track any adverse events during treatment and up to 30 days after the last dose. The study also evaluates other patient-reported outcomes related to hair growth and quality of life over time.

Researchers are evaluating the safety, side effects, and optimal dose of the drug cabozantinib when added to standard chemotherapy for patients newly diagnosed with osteosarcoma, a type of bone cancer. This phase II/III trial compares the effects of standard chemotherapy alone versus chemotherapy combined with cabozantinib, which is a kinase inhibitor that may slow tumor growth by blocking signals needed for blood vessel formation and tumor cell growth. The study also aims to assess whether adding cabozantinib improves survival and event-free survival rates. Participants receive a combination of chemotherapy drugs including methotrexate, doxorubicin, and cisplatin, known as MAP chemotherapy. In different study groups, some patients receive MAP alone, while others receive MAP plus cabozantinib taken orally. Treatment is divided into induction, consolidation, and maintenance phases lasting several 35-day and 28-day cycles, depending on the risk group and treatment arm. Some patients also undergo surgery or other local control methods as part of their care. During the study, participants undergo various scans such as X-rays, CT, MRI, PET, or bone scans at diagnosis and at set times to monitor disease status. Blood samples are collected regularly for tumor profiling and biomarker studies. Researchers measure outcomes including dose-limiting toxicities, event-free survival, overall survival, symptom burden, and treatment tolerability. Participants are followed up for up to five years after completing treatment to assess long-term effects and outcomes.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase II/III trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase II/III trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating an Internet-based pain coping skills program combined with enhanced usual care to see if it improves pain severity and pain interference in adult cancer survivors with persistent cancer-related pain. This study also looks at other effects such as opioid medication use, quality of life, pain management confidence, fatigue, sleep, emotional distress, positive feelings, pain impact, cognitive problems, and cognitive performance. The study enrolls 250 participants who have been treated for invasive cancer and are experiencing ongoing pain. Participants are randomly assigned to one of two groups. One group receives access to an 8-session online pain coping program plus pain education alongside their usual care, which they complete within 10 weeks and can revisit during that time. After the study ends, they retain access to the program. The other group receives pain education only at their initial clinic visit and will be offered access to the online program after completing the 6-month follow-up assessment. Each participant is involved in the study for about 9 months, from randomization through final follow-up at week 34. Researchers will assess changes in pain severity and interference primarily from baseline to 10 weeks, with additional follow-ups at 22 and 34 weeks. They will also monitor opioid use, quality of life, and pain management self-efficacy. Participants complete various questionnaires and assessments throughout, and adherence to the online program is tracked. The study aims to better understand how this Internet-based approach may help manage cancer-related pain.