Colchester

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating whether less frequent dosing of pembrolizumab after six months of standard treatment is safe and effective for patients with advanced non-small cell lung cancer NSCLC. Pembrolizumab, an immunotherapy targeting the PD-1 receptor, has improved outcomes in NSCLC, but current dosing every six weeks for up to two years may result in overtreatment. This UK phase III trial aims to find if reducing dose frequency can maintain effectiveness while improving quality of life and lowering costs. Participants who have received six months of pembrolizumab, with or without chemotherapy, and plan to continue treatment will be randomized to receive pembrolizumab intravenously every six weeks control or every twelve weeks initially. If the 12-week dosing is found to be not less effective, additional groups receiving doses every nine, fifteen, and eighteen weeks will be included. Patients who experience disease progression while on reduced frequency dosing can return to the standard six-week schedule. Throughout the study, participants will be monitored for overall survival at 18 months from randomization, along with other outcomes such as progression-free survival, response rate, duration of response, and adverse events over two years. The study involves regular hospital visits for treatment and assessments, and the results may lead to safer, more convenient treatment options for NSCLC patients. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor CDK46i and letrozole compared to placebo plus CDK46i and letrozole in adults with endocrine-sensitive PIK3CA-mutated hormone receptor-positive HR, HER2-negative advanced breast cancer. This phase III, randomized, double-blind study focuses on participants who have measurable disease and meet specific hormone receptor and HER2 status criteria. Participants are randomly assigned to receive either oral inavolisib once daily along with letrozole and CDK46i or placebo once daily with letrozole and CDK46i. The CDK46i is given on a schedule of either Days 1-21 or Days 1-28 of each 28-day cycle. The study includes parallel groups to compare these treatment combinations over time. During the study, participants will be monitored for progression-free survival, overall survival, response rates, duration of response, clinical benefit, and changes in pain, physical function, and global health status. Safety will be assessed by tracking adverse events and patient-reported treatment side effects using questionnaires. The study will follow participants for up to seven years, with regular evaluations to track disease status and quality of life.

Researchers are evaluating the safety, usability, implantation accuracy, and effectiveness of the MINIject S device in adults with open angle glaucoma. This study involves multiple centers across several countries and includes a first-in-man phase to identify the best insertion tool for the device. The trial also assesses the chosen tool in patients who have both glaucoma and operable cataracts undergoing combined surgery. The study is divided into two parts. Part 1 compares three different versions of the insertion tool to implant the MINIject S device into the supraciliary space, with participants and evaluators unaware of which tool is used. Part 2 expands the study to a larger group using the selected insertion tool during combined glaucoma and cataract surgery with intraocular lens implantation. Each participant receives one version of the investigational device. Participants will undergo assessments including checking device placement accuracy one week after surgery and evaluating ease of use during the procedure. Additional follow-up visits at 6, 12, and 24 months will measure changes in visual acuity, intraocular pressure, medication use, endothelial cell density, and rates of secondary surgeries and adverse events. Participants must be able to follow study instructions and attend scheduled visits. The study lasts until July 2028, with primary outcome data expected by August 2026.

Researchers are evaluating the combination of bleximenib, venetoclax VEN, and azacitidine AZA compared to placebo with VEN and AZA in treating adults with newly diagnosed Acute Myeloid Leukemia AML who have mutations in the NPM1 or KMT2A genes. This Phase 3 study focuses on participants who are not eligible for intensive chemotherapy due to age or other health conditions. The goal is to understand how these treatments work in this specific AML population. Participants receive treatment in 28-day cycles, either with bleximenib plus VEN and AZA or placebo plus VEN and AZA. Bleximenib, VEN, and placebo are taken orally, while AZA is given intravenously or under the skin. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for response to treatment including complete remission and overall survival for up to over four years. Researchers will track event-free survival, duration and timing of remission, transfusion independence, and other health outcomes. Safety is also closely observed through adverse events and lab tests. Participation involves regular visits for treatment and assessments over the study period.

This trial focuses on people with relapsed or refractory multiple myeloma who have previously received specific treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies. It aims to study preventive treatments to reduce the occurrence, severity, and duration of taste changes caused by talquetamab, and to better understand the symptoms related to both talquetamab and ramantamig therapies. The study is a Phase 2 trial designed to improve management of oral side effects during treatment. Participants receive talquetamab or ramantamig drugs administered subcutaneously. Some groups receive talquetamab alone, while others receive talquetamab combined with different preventive treatments prophylaxes A, B, C, or D starting before talquetamab therapy. Prophylaxes A, B, and C are given orally, while prophylaxis D is applied topically. Treatment continues until disease progression, unacceptable side effects, withdrawal, or end of study, with prophylaxis lasting up to 12 months but possibly longer based on clinical benefit and doctor decision. During the study, participants will undergo various assessments including taste tests and questionnaires about oral symptoms, quality of life, and body measurements. Researchers will monitor the occurrence and severity of taste changes and other oral toxicities over time, dose adjustments, treatment responses, and safety events. This comprehensive monitoring may last up to 36 months, helping to better characterize the side effects and treatment outcomes for multiple myeloma patients receiving these therapies.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. Participants will be randomly assigned to receive either ABVD chemotherapy doxorubicin, bleomycin, vinblastine, and dacarbazine or A2VD chemotherapy doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support. After two 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.

Researchers are evaluating surgical options for patients with low risk differentiated thyroid cancer. This phase III study aims to determine if hemithyroidectomy, which removes part of the thyroid gland, is an acceptable and cost-effective alternative to total thyroidectomy, which removes the entire gland. The trial includes two groups of patients based on their prior surgery status and diagnosis method, focusing on recurrence risk and prognosis. Participants are randomly assigned to different surgical treatments depending on their group. Group 1 patients who have had prior thyroid surgery will either have a second operation to remove the remaining thyroid tissue or undergo surveillance without further surgery. Group 2 patients who have not had surgery will be randomized to receive either hemithyroidectomy or total thyroidectomy in a single operation. The trial plans to recruit 456 participants and follow them regularly for six years after surgery. During the study, patients will attend follow-up visits post-surgery and then annually for six years. Researchers will monitor cancer recurrence rates at three and five years, assess the site and risk of recurrence, and record additional investigations and procedures after surgery. They will also evaluate surgical complications, voice function, hormone replacement needs, quality of life, and healthcare resource use at multiple time points. This comprehensive monitoring aims to compare outcomes between the different surgical approaches and understand their impact on patients health and well-being over time.