Farmington

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. 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 specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

This research aims to evaluate the efficacy and safety of belantamab mafodotin given with standard cancer treatments in adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or is not responding to prior treatments. The study focuses on whether giving belantamab mafodotin less frequently can still control the cancer while reducing side effects, especially those affecting the eyes. It is a phase 2, open-label study sponsored by GlaxoSmithKline. Participants will receive belantamab mafodotin combined with one of three standard treatment regimens pomalidomide and dexamethasone bortezomib and dexamethasone or carfilzomib and dexamethasone. The study uses an extended dosing schedule to assess if less frequent dosing maintains effectiveness. The treatment continues as per the assigned combination, with no randomization, in multiple centers. During the study, participants will be regularly assessed for response to treatment, including overall response rate and complete response rate, up to about 52 months. Safety will be monitored by recording side effects and eye health through ophthalmic exams. Participants will undergo laboratory tests and clinical evaluations throughout the study. The research will also track how well patient-reported eye symptoms match clinical findings, with the total study duration extending up to approximately four years.

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 studys 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, HER2-negative advanced breast cancer. The study aims to assess how well ZOLADEX 10.8 mg suppresses ovarian function by measuring luteinizing hormone LH levels during treatment. This Phase 1, single-arm, open-label trial seeks to understand the degree and consistency of ovarian suppression in this patient group. Participants will receive two doses of ZOLADEX 10.8 mg as subcutaneous injections one on Day 1 Week 1 and another on Day 85 Week 12. The study focuses on tracking ovarian suppression by measuring hormone levels over the treatment period, with no placebo or comparison group involved. During the study, participants will have their LH levels measured at various time points, including Week 6 as the primary outcome and Weeks 12, 18, and 24 for secondary outcomes. Other assessments include estradiol suppression and absence of menses at these same intervals. Participants will be monitored for safety and treatment effects throughout the study which may last up to 24 weeks after treatment initiation.

Researchers are evaluating the effectiveness of trastuzumab deruxtecan T-DXd in patients with HER2-positive IHC 3 locally advanced, unresectable, or metastatic solid tumors in the United States. This observational study focuses on patients who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options. The study excludes patients with breast, colorectal, non-small cell lung cancer, gastricgastroesophageal junction cancers, and hematological malignancies. Participants will be enrolled at approximately 30 sites including community oncology practices, hospital systems, and academic medical centers. They will start treatment with T-DXd as part of routine clinical care according to the FDA label. The study is designed to reflect real-world clinical practice and will observe patients from the point they begin T-DXd treatment. During the study, researchers will collect data on tumor response and treatment outcomes over up to 2.5 years after enrollment. They will assess real world response rate, duration of response, time to treatment discontinuation, and time to next treatment. Participants clinical progress and outcomes will be monitored through their usual healthcare visits, with no additional interventional procedures required for the study duration.

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 CDK46 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.

Researchers are evaluating whether the combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer that remains after surgery and pre-surgical therapy. This phase 3 trial focuses on participants who have residual invasive disease following neoadjuvant therapy and surgery. The study aims to better understand outcomes for this condition where cancer persists despite earlier treatments. Participants are randomly assigned to one of two groups. One group receives SG intravenously at 10 mgkg on Days 1 and 8 of 21-day cycles along with pembrolizumab 200 mg intravenously on Day 1, repeated for up to 8 cycles. The other group receives physicians choice treatment pembrolizumab alone or pembrolizumab combined with oral capecitabine, also given over 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, or other specified reasons. During the study, participants are monitored for invasive disease-free survival up to 60 months, along with overall survival, distant disease-free survival, recurrence-free survival, and quality of life measures. Safety is assessed through tracking treatment-related adverse events and laboratory tests for up to 38 months plus 30 days. This long-term follow-up helps evaluate the impact of the treatments on disease outcomes and participant well-being.