Milford

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the effectiveness, safety, and drug levels of Deucravacitinib BMS-986165 in adolescents aged 12 to less than 18 years who have moderate to severe plaque psoriasis. This phase 3 study is randomized, double-blind, and placebo-controlled to thoroughly assess the treatments impact on this skin condition. The study is sponsored by Bristol-Myers Squibb and aims to provide detailed information on how Deucravacitinib works in this younger population. Participants will receive either Deucravacitinib or a placebo, with doses given on specified days as part of the treatment. The study groups include an active drug group and a placebo group, and the design is parallel to compare these treatments directly. The treatment period includes monitoring drug levels and observing the participants responses over time. During the study, participants will be regularly assessed for improvements in their psoriasis using measures such as the Psoriasis Area and Severity Index PASI and the static Physicians Global Assessment sPGA at week 16. Additional evaluations include body surface area involvement, itch severity, quality of life, and antibody protection. Safety is closely monitored through laboratory tests, physical exams, vital signs, and adverse event tracking for up to five years, with ongoing measurement of growth and sexual maturation during this time.

Researchers are evaluating if the study drugs abemaciclib and letrozole are effective and safe for people with advanced or recurrent estrogen receptor-positive ER endometrial cancer that is mismatch repair proficient and has tumor protein p53 TP53 wild-type. This phase 2, single arm trial focuses on maintenance treatment following chemotherapy with or without anti-PD-L1 blockade. The FDA has not approved these drugs for endometrial cancer but has approved them for other uses. Participants will receive abemaciclib tablets twice daily and letrozole tablets once daily in 21-day cycles. Treatment will continue for up to 2 years. Scans such as X-rays, CT, MRI, or PET will be done every 9 weeks for the first 9 months, then annually. After treatment ends, participants will have assessments and continue follow-up for up to 3 years. The study is supported by Eli Lilly, which provides funding and the abemaciclib drug. During the study, participants will undergo screening and regular evaluations including scans, blood tests, and electrocardiograms EKGs. Researchers will monitor progression-free survival over 2 years as the primary outcome. Secondary outcomes include adverse event rates, overall survival up to 5 years, and objective response rate. Participants must have good performance status and normal organ function to join and will be followed closely throughout treatment and follow-up periods.

Researchers are evaluating a new imaging approach for men with intermediate- or high-risk prostate cancer who plan to receive hormone therapy and radiation treatment. The study aims to see if using a special imaging test during hormone therapy can help doctors better identify where active cancer remains in the prostate. This could allow for more precise radiation targeting, potentially reducing side effects by avoiding unnecessary treatment to healthy areas. All participants will receive standard hormone therapy androgen deprivation therapy or ADT for about six months, combined with stereotactic body radiation therapy SBRT beginning around 10 weeks after starting ADT. Three PSMA PETCT scans and MRI scans will be performed before hormone therapy begins, about eight weeks after ADT starts before radiation planning, and at 24 weeks end of treatment. Based on these scans, some patients may receive an extra focused radiation boost to areas where active cancer remains, while others may not need this boost if the cancer has responded well. Participants will be monitored with imaging, blood tests measuring PSA levels, and patient-reported quality of life questionnaires focusing on urinary, bowel, and sexual symptoms. Researchers will assess how well the imaging guides radiation planning and treatment targeting. The total participation lasts about six months, during which standard treatments are combined with experimental imaging to improve radiation precision and reduce side effects for future patients.

This trial focuses on both women and men diagnosed with Stage I HER2-positive invasive breast cancer. It aims to compare two different combinations of HER2-targeted therapies given after surgery, studying how well each treatment controls the cancer and their side effects. The study is a randomized phase II trial supported by Genentech and led by the Dana-Farber Cancer Institute, evaluating long-term benefits and disease-free survival over several years. Participants are randomly assigned to one of two groups. One group receives six cycles of intravenous trastuzumab-emtansine T-DM1 every three weeks, followed by eleven cycles of subcutaneous trastuzumab every three weeks. The other group receives weekly intravenous paclitaxel for twelve weeks along with subcutaneous trastuzumab every three weeks, continuing trastuzumab alone for additional cycles. The entire treatment period lasts about one year. During the study, participants undergo screening and regular laboratory evaluations along with follow-up visits. Researchers monitor side effects, quality of life, symptoms related to therapy, and cardiac function. The main outcomes measured include the incidence of toxicities during the first 18 weeks and disease-free survival over up to 72 months. Participants are followed for five years after treatment to assess long-term outcomes and safety.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

Researchers are evaluating ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer NSCLC whose tumors show high PD-L1 expression. This phase 3 study compares ivonescimab to pembrolizumab, focusing on overall survival and progression-free survival to understand which treatment may better support patients with this condition. Participants will be randomly assigned to receive either ivonescimab or pembrolizumab through intravenous injection. The study is double-blinded and multiregional, involving continuous treatment and monitoring for up to approximately 36 months. Both groups receive their assigned treatment regularly during this period, with careful observation of treatment responses and side effects. During the trial, participants will undergo evaluations including scans to measure tumor size, laboratory tests, and assessments of adverse events. Researchers will track overall survival, progression-free survival, response rates, disease control, and duration of response. Safety monitoring will continue for up to 24 months after the last dose. The total study period extends until June 2029, allowing long-term data collection on treatment effects and safety.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of ORKA-002 in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled study aims to find the best induction dosing regimen of ORKA-002. Approximately 160 adult participants with this skin condition will take part in the Phase 2 trial. Participants will be randomly assigned to receive one of three different induction dosing regimens of ORKA-002 or a placebo. Both ORKA-002 and placebo are given by subcutaneous injection. The study includes three periods Screening, Induction, and Post-treatment Follow-up. During the study, participants will undergo assessments including evaluations of skin severity using PASI and IGA scores. Researchers will monitor treatment-emergent adverse events through Week 48. The primary outcome is the proportion of participants achieving complete clearance of psoriasis at Week 16. The total participation time includes screening, treatment, and follow-up periods to assess safety and treatment response.

Researchers are studying glioblastoma GBM, a fast-growing brain cancer affecting older adults who have special medical and care needs. This trial explores whether giving higher radiation doses in fewer sessions dose-escalated hypofractionation can improve treatment outcomes compared to the standard shorter radiation course. The study is a phase 2 randomized trial aiming to compare safety and effectiveness of these two radiation schedules in people aged 65 and older with newly diagnosed GBM. Participants will receive radiation therapy for three weeks, either as a standard hypofractionated regimen or a dose-escalated hypofractionated regimen with higher daily radiation doses. Both approaches deliver fewer radiation treatments than traditional schedules but differ in daily dose intensity. The study randomly assigns patients to one of these two groups to assess which approach may offer better results. During the trial, participants undergo screening to confirm eligibility, receive radiation treatments, and have follow-up visits to track symptoms and side effects. Researchers will measure overall survival, progression-free survival, treatment-related side effects, quality of life, mood, geriatric assessments, and performance status over up to six months after enrollment. The study will monitor participants for about one year on average to evaluate the effects of the treatments.