Bristol

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating the feasibility and acceptability of completing patient-reported outcomes (PROs) among adolescents and young adults (AYAs) aged 18 to 39 with various types of cancer. This pilot randomized controlled trial compares two approaches: allowing AYAs to choose five health-related quality of life (HRQOL) domains to report on (Choice PRO) versus assigning five fixed domains (Fixed PRO). The study aims to improve how PRO data is collected and used to better address patient needs in clinical and supportive care settings. Participants will be randomly assigned to either the Choice PRO group, where they select five of 15 PRO domains to complete at each assessment, or the Fixed PRO group, where they complete the same five predetermined domains at each time point. Assessments will be completed online using the EASEE-PRO platform at baseline and 1, 3, 6, and 12 months. Reminder calls and text messages will be used to encourage adherence and reduce missing data. The study will also explore how AYAs want their PRO data shared with themselves, their families, and healthcare providers. During the study, participants will complete questionnaires combining computerized adaptive tests and fixed short forms. Researchers will measure the completion rates and acceptability of the PROs at one month and baseline, respectively, and compare these between groups. The study requires participants to have internet access and the ability to provide informed consent and accurate self-reports. The total participation time includes follow-up over one year with multiple assessments to capture patient experiences and preferences.

Researchers are evaluating a connected customized treatment platform called CONCURxP to help patients with metastatic breast cancer adhere to their CDK4/6 inhibitor medication schedules. The study compares CONCURxP, which combines a WiseBag medication monitoring device with personalized text message reminders and healthcare provider follow-ups, to enhanced usual care where patients only use the WiseBag and receive educational materials. This research aims to improve medication adherence, symptom management, quality of life, and communication between patients and providers over a 12-month period. Participants are randomly assigned to one of two groups: Arm A uses the WiseBag and receives educational materials every four weeks for 12 months, while Arm B uses the WiseBag along with personalized text message reminders and healthcare provider follow-ups as part of the CONCURxP program. Patients in Arm B may also complete an interview within six months after study completion. A separate group, Arm C, includes non-patient participants who complete an interview 15 to 39 months after the first patient enrollment. After the intervention period, patients may be monitored for an additional six months. During the study, participants' medication adherence is tracked electronically using the WiseBag at 12 months after starting medication. Researchers also assess self-reported adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, financial worry, healthcare use, and survival outcomes. Patient interviews and electronic health record reviews support the collection of these data. The study involves surveys, text messaging, medication tracking, and follow-ups to understand and improve adherence and overall patient experience.

Researchers are evaluating a phase III trial to compare a text-based smoking cessation intervention with a printed manual to help rural cancer survivors who smoke quit smoking. The study focuses on patients diagnosed with cancer in the past 10 years who currently smoke at least five cigarettes daily and live in rural areas. The trial aims to assess the effectiveness of a scheduled gradual reduction program paired with support messages versus an informational booklet for quitting smoking. Participants are randomly assigned to one of two groups. One group follows an eight-week personalized schedule to gradually reduce cigarette use and receives cessation support messages via text for 12 weeks. The other group receives the National Cancer Institute's Clearing the Air booklet to guide gradual quitting. After completing the intervention, patients are followed up at six months to evaluate outcomes. During the study, participants complete questionnaires and provide urine samples to biochemically validate smoking cessation. Researchers measure smoking cessation success up to six months after the quit date and assess quality of life at 30 days and six months post-quit. The study includes ongoing monitoring through text messages and patient-completed measures, ensuring comprehensive data collection over the follow-up period.

Researchers are evaluating whether starting treatment early with venetoclax and obinutuzumab improves overall survival compared to delayed treatment in patients newly diagnosed with high-risk chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase III trial focuses on patients who have asymptomatic disease but high-risk factors such as a high CLL-International Prognostic Index score or complex cytogenetics. Venetoclax is a drug that blocks a protein needed for cancer cell survival, while obinutuzumab is an immunotherapy that may help the immune system attack cancer cells and prevent tumor growth. Participants are randomly assigned to one of two groups: early treatment or delayed treatment. Both groups receive obinutuzumab intravenously on specific days in cycles and venetoclax orally daily during treatment cycles, with each cycle lasting 28 days for up to 12 cycles unless the disease progresses or unacceptable side effects occur. The early treatment group starts therapy as soon as they meet eligibility, while the delayed group begins once standard criteria for active treatment are met. Throughout the study, participants undergo procedures including CT scans, blood sample collection, and bone marrow aspiration and biopsy. During the study, participants are monitored closely through various tests and questionnaires to assess overall survival, quality of life using the FACT-Leukemia scale, response to treatment, and disease progression. The trial also studies measurable residual disease and various biomarkers to understand treatment impact. After treatment, participants are followed for up to 10 years to observe long-term outcomes and safety.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the effectiveness of neratinib alone compared to a combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors, including gynecologic cancers. This phase II trial focuses on slowing or stopping tumor growth by blocking abnormal proteins that signal cancer cells to multiply. It aims to assess progression-free survival as the primary outcome and also evaluates response rates, overall survival, and treatment-related side effects. The study further explores genetic markers and tumor profiles to understand treatment response and resistance. Participants are randomly assigned to one of two treatment arms. In Arm I, patients take neratinib orally once daily on days 1-14 of an initial cycle, then continuously on days 1-28 of each subsequent 28-day cycle. Arm II follows the same initial neratinib schedule, but adds palbociclib orally once daily on days 1-21 of each subsequent cycle. Treatment continues until disease progression or unacceptable side effects occur. Patients experiencing progression on neratinib alone may switch to the combination therapy. Both arms include various scans and blood tests, with optional tumor biopsies before and during treatment. During the study, participants undergo monitoring with echocardiograms or MUGA scans, CT or MRI scans, and blood sample collections to track tumor status and treatment effects. Researchers collect tissue samples to study tumor genetics and blood-based DNA markers at baseline and follow-up. After completing treatment, patients are followed every three months for up to two years to observe long-term outcomes and safety. The total participation duration includes treatment cycles and extended follow-up for disease progression or survival assessment.

Researchers are evaluating high-dose vitamin D supplementation as a treatment for bone loss caused by androgen-deprivation therapy (ADT) in men with prostate cancer stages I to IVA. This phase III trial aims to see if vitamin D helps keep bones strong, reduces the number of falls, lowers fatigue, and improves quality of life in these patients. The study focuses on men aged 50 years or older who are undergoing or starting ADT. Participants are randomly assigned to one of two groups: one receives high-dose vitamin D orally once a week for 52 weeks, and the other receives a placebo with the same schedule. Both groups undergo blood collection and dual-energy x-ray absorptiometry (DXA) scans to measure bone mineral density (BMD) at the total hip, femoral neck, distal radius, and lumbar spine at the start and during the study. Additional assessments include questionnaires on falls, fractures, quality of life, pain, fatigue, sleep, and daily activities. Throughout the 52-week study, participants provide blood samples and complete DXA scans to monitor changes in bone density. Researchers evaluate the reduction in bone loss at various sites, track falls and fractures, and assess quality of life and symptoms reported by patients. Safety and adherence are monitored to understand the effects of vitamin D supplementation during ADT treatment in prostate cancer patients.