Farmington

Researchers are evaluating new treatment options for people with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific gene mutation called KRAS G12C. This study aims to learn about the safety and tolerance of adding calderasib and cetuximab, two targeted therapies, to a chemotherapy regimen called mFOLFOX6. The study also compares how long participants live without their cancer growing or spreading when receiving the combination treatment versus standard chemotherapy with or without bevacizumab. The study has two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil given every two weeks. The other group will receive mFOLFOX6 chemotherapy every two weeks, with or without bevacizumab or a bevacizumab biosimilar, based on the investigator's choice. Treatment continues until certain criteria are met for stopping. Participants will be closely monitored through up to approximately 44 months or longer for side effects, treatment discontinuation, and how long their cancer remains stable without worsening. Researchers will also assess survival, quality of life using questionnaires, and response to treatment over several years. Safety and efficacy data will be collected throughout the study duration, which includes follow-up assessments up to 5 years.

Researchers are evaluating the effectiveness and safety of combining divarasib and pembrolizumab compared to pembrolizumab with pemetrexed and carboplatin or cisplatin for first-line treatment in adults with KRAS G12C-mutated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This phase III study focuses on patients who have not received prior systemic treatment for this type of lung cancer and aims to provide new options for this specific mutation. Participants are randomly assigned to one of two groups. One group receives an oral daily dose of divarasib along with pembrolizumab given by intravenous infusion every three weeks. The other group receives pembrolizumab combined with pemetrexed and either carboplatin or cisplatin, also administered intravenously every three weeks. Treatments continue according to the study schedule to assess how well each combination works and their safety profiles. Throughout the study, participants will be closely monitored for progression-free survival and overall survival for up to approximately five years. Additional assessments include tumor response, quality of life related to lung cancer symptoms, duration of response, and side effects reported by patients. Safety is also tracked by recording adverse events and their impact on daily activities. This comprehensive monitoring helps researchers understand the full effects of the treatments over time.

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months (5 years). The study allows prior use of CDK4/6 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patient's randomization.

Researchers are evaluating the combination of disitamab vedotin and tucatinib in people with advanced or metastatic breast or gastric cancers that express the HER2 protein. These solid tumors, which start in organs like the breast or stomach, tend to grow quickly or spread, making treatment challenging. This Phase 2 clinical trial aims to test how safe and effective this combination therapy is, particularly for tumors that have HER2, which helps cancer cells grow faster and spread more easily. The study includes several phases: a dose escalation phase to find the best dose of disitamab vedotin combined with tucatinib, followed by a dose optimization phase to assess safety and effectiveness at selected doses. After these phases, an expansion phase will evaluate this combination in four groups of participants with different HER2 expression levels and cancer types. Disitamab vedotin is given intravenously, while tucatinib is taken orally twice daily at 300 mg. Participants receive the combination therapy according to their assigned study group. During the trial, participants will undergo regular assessments including scans and lab tests to monitor tumor response and safety. The study will track side effects, dose changes, and overall treatment effects over several years, with some evaluations extending up to five years after treatment. Researchers will measure outcomes such as tumor response rate, duration of response, disease control, progression-free survival, and overall survival. Safety monitoring includes checking for adverse events and laboratory abnormalities throughout the study period.

Researchers are evaluating telisotuzumab vedotin compared to docetaxel in adults with non-squamous non-small cell lung cancer (NSCLC) that has been previously treated. This study aims to determine if telisotuzumab vedotin works better and to assess its safety. Participants will have NSCLC with overexpression of the c-Met protein and will have previously received certain therapies. The trial is a phase 3, open-label, randomized study conducted globally with about 698 participants. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until criteria for stopping the study drug are met. After the main study, participants who benefit may continue treatment through an extension or rollover study. Treatments are given at hospitals or clinics worldwide. Participants will attend regular visits where doctors will monitor their health through medical assessments, blood tests, and questionnaires. Researchers will check how the disease is progressing and watch for side effects. The main outcomes measured include progression-free survival and overall survival over approximately 39 months. Secondary outcomes include tumor response and changes in quality of life and physical functioning. Safety and tolerability will be closely observed throughout the study.

Researchers are evaluating the safety and effectiveness of belantamab mafodotin combined with standard cancer treatments in adults with multiple myeloma that has returned or is not responding to current therapies. This Phase 2 study focuses on whether giving belantamab mafodotin less frequently can still control the cancer while causing fewer side effects, especially those affecting the eyes. The trial is sponsored by GlaxoSmithKline and aims to understand the overall treatment response and safety over time. Participants will receive belantamab mafodotin alongside one of three standard treatment combinations: pomalidomide with dexamethasone, bortezomib with dexamethasone, or carfilzomib with dexamethasone. These combinations are given on an extended dosing schedule to study their effects. The treatment period and follow-up last up to about 52 months, during which participants will be closely monitored. During the study, participants will undergo regular evaluations including response assessments, eye exams, and monitoring for side effects. Researchers will track overall response rates, complete responses, minimal residual disease, and duration of response. Safety will be assessed by recording adverse events and changes in eye health. This long-term monitoring helps understand how well the treatments work and how safe they are for participants over time.

Researchers are evaluating the effectiveness of subcutaneous isatuximab delivered via an on-body delivery system combined with weekly carfilzomib and dexamethasone in adults with relapsed or refractory multiple myeloma who have had 1 to 3 prior treatments. This Phase 2, single-arm, open-label study aims to assess the overall response rate to this combination treatment for this condition. Participants will receive isatuximab subcutaneously on specific days within each 28-day cycle: days 1, 8, 15, and 22 during the first cycle, and days 1 and 15 for subsequent cycles. Carfilzomib is given intravenously starting with a dose on day 1 of cycle 1, followed by escalated doses on days 8 and 15, then on days 1, 8, and 15 in later cycles. Dexamethasone is administered intravenously or orally on designated days throughout each cycle. Treatment continues for up to 12 months unless stopped early. Before treatment, participants undergo a screening period lasting up to 28 days. After finishing treatment, there is an end-of-treatment visit about 30 days after the last dose, followed by a study follow-up period lasting until death or the study's final cutoff date. Researchers will monitor response rates, side effects such as infusion or injection site reactions, laboratory changes, and patient satisfaction. Some participants will have additional blood tests to measure drug levels and immune responses.

Researchers are evaluating ovarian suppression in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. This phase 1 trial aims to measure how effectively ZOLADEX 10.8 mg suppresses ovarian function by tracking luteinizing hormone (LH) levels during treatment. The study focuses on women aged 18 to 55 who have either not received gonadotropin-releasing hormone (GnRH) treatment or have been exposed to it for less than six months. Participants will receive two subcutaneous injections of ZOLADEX 10.8 mg: one on Day 1 (Week 1) and another on Day 85 (Week 12). The study monitors ovarian suppression by measuring LH and estradiol levels and recording the absence of menstruation over 24 weeks. This open-label, multicenter trial does not involve a placebo or comparator group. During the study, participants will undergo regular blood tests to measure hormone levels at Weeks 6, 12, 18, and 24. Researchers will assess ovarian suppression consistency and safety by evaluating hormone thresholds and menstrual status. The total participation duration covers at least 24 weeks, with ongoing monitoring for treatment effects and adverse events throughout the trial period.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups: one receiving standard endocrine therapy chosen by the doctor (including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen) with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patient's randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

Researchers are evaluating palazestrant (OP-1250) compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK4/6 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.