Bedford

This trial enrolls participants from previous studies evaluating adagrasib either alone or combined with other cancer therapies in patients with non-small cell lung cancer, colorectal cancer, and other advanced solid tumors. It is an open-label continuation study designed to provide long-term treatment for cancer patients who have already participated in those parent trials. The study is sponsored by Mirati Therapeutics Inc. and focuses on treatment of solid tumors. Participants receive adagrasib and may also receive other cancer drugs such as pembrolizumab, cetuximab, pemetrexed, docetaxel, irinotecan, leucovorin, oxaliplatin, and fluorouracil. The dosing and schedule are specified but depend on the parent study protocols. This trial includes multiple experimental arms reflecting different treatment combinations or regimens, continuing treatment for eligible patients who showed clinical benefit in the parent studies. During the study, participants are monitored for adverse events up to 90 days after their last dose or if they discontinue treatment. Researchers track serious adverse events, treatment-related discontinuations, and deaths related to adverse events. Participation involves ongoing treatment and safety assessments, with the study lasting until the primary completion date in February 2028. The study does not include healthy volunteers and involves adults aged 18 years and older.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating treatments for people with metastatic colorectal cancer mCRC who have already received certain standard therapies including irinotecan, oxaliplatin, fluoropyrimidine, and bevacizumab. The study aims to see if treatment with precemtabart tocentecan Precem-TcT, alone or combined with bevacizumab, can prolong overall survival compared to the combination of trifluridinetipiracil FTD-TPI plus bevacizumab. This is a randomized, open-label Phase 3 clinical trial investigating these options for previously treated mCRC patients. Participants are randomly assigned to one of three groups Precem-TcT alone given intravenously once every 3 weeks in 21-day cycles Precem-TcT combined with bevacizumab, where bevacizumab is administered intravenously every 3 weeks or every 2 weeks depending on the cycle schedule or FTD-TPI plus bevacizumab, with FTD-TPI given orally twice daily on specified days in 28-day cycles. The study observes treatment effects while participants receive these medications according to their assigned group. During the trial, participants will be regularly assessed for overall survival and disease progression over about 19 months. Researchers will also monitor tumor response, duration of response, adverse events, drug concentrations, immune response to the drugs, and quality of life using questionnaires. These assessments include clinical evaluations and laboratory tests conducted at scheduled intervals throughout treatment. Participants remain under close medical monitoring to track treatment impact and safety until the studys end.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan R-DXd in adults with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes a Phase 2 dose-optimization part to find the best dose based on safety and effectiveness, followed by a Phase 3 part comparing R-DXd to chemotherapy chosen by the investigator. The study targets tumors that overexpress CDH6, a protein that R-DXd specifically binds to. Participants are randomly assigned to receive intravenous R-DXd at various doses every three weeks or an investigators choice of chemotherapy drugs including paclitaxel, pegylated liposomal doxorubicin, or topotecan. The Phase 2 portion focuses on determining the optimal dose, while the Phase 3 portion compares the recommended dose with standard chemotherapy. Treatments are given through IV infusions according to the assigned group. During the study, participants undergo scheduled visits for drug administration, safety monitoring, and evaluations including imaging scans to assess tumor response. Researchers measure outcomes such as objective response rate, progression-free survival, overall survival, duration of response, symptom changes, and pharmacokinetics over periods up to 40 months. Safety is closely monitored through adverse event tracking and laboratory tests, with participants followed until the studys completion in 2030.

Researchers are evaluating the use of TRK-950 combined with ramucirumab and paclitaxel compared to ramucirumab plus paclitaxel alone in people with gastric or gastro-esophageal junction adenocarcinoma. This phase 2 study aims to assess the effectiveness, safety, best dose, and the development of anti-drug and neutralizing antibodies related to TRK-950. The main goal is to measure progression-free survival, with additional goals including overall survival, response rates, and safety. Participants are randomly assigned to one of three groups one receiving 5 mgkg of TRK-950 with ramucirumab and paclitaxel, another receiving 10 mgkg of TRK-950 with the same combination, and a control group receiving ramucirumab and paclitaxel alone. Treatments are given intravenously on specified days in 28-day cycles, with TRK-950 administered on days 1, 8, 15, and 22, ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. During the study, participants will have various assessments including imaging scans, blood tests for drug levels and antibodies, evaluations of side effects, physical exams, and quality of life questionnaires. Progression-free survival is tracked up to about 24 months, and safety is monitored up to 45 days after the last study dose. The study includes regular treatment cycles and follow-up evaluations to monitor the disease and response to treatment.

Researchers are evaluating the safety and effectiveness of an experimental drug combination, fianlimab and cemiplimab, compared to the approved combination of relatlimab and nivolumab Opdualag in adults with advanced or metastatic melanoma, a serious type of skin cancer. This Phase 3 study aims to understand how well these treatments work and what side effects they may cause. The study also investigates how much of the study drugs are present in the blood over time and whether the body produces antibodies against these drugs. Participants are randomly assigned to receive either the experimental combination of fianlimab plus cemiplimab given intravenously every three weeks or the approved combination of relatlimab plus nivolumab given intravenously every four weeks. The study compares these two treatments in parallel groups. Treatments are administered during the study period, and participants are monitored regularly to assess the effects and safety of the medications. During the trial, participants undergo assessments including tumor measurements following standardized criteria to evaluate response to treatment. The study also monitors for adverse events, laboratory abnormalities, and the presence of anti-drug antibodies. The main outcome measure is the objective response rate, evaluated over up to 72 months. Participants are followed for safety and effectiveness throughout this period, which may last several years in total.

Researchers are conducting a randomized controlled trial to compare survival outcomes between robotic-assisted laparoscopy and open hysterectomy with lymph node assessment for early-stage cervical cancer. The study aims to determine if robotic hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy in terms of disease-free survival. It includes patients with specific cervical cancer stages and tumor sizes suitable for surgery. Participants will undergo either a radical or simple hysterectomy using either traditional open surgery or a robotic-assisted technique. In the robotic group, the vagina is closed before colpotomy, and certain vaginal manipulators are not allowed. Both groups may have salpingectomy and oophorectomy with or without ovarian transposition. Surgeons will document operative details, including any complications, blood loss, and reasons for conversion to open surgery. During the trial, participants will be closely monitored with preoperative assessments like labs, EKG, and MRI to confirm eligibility. Surgical findings and complications will be recorded. The primary outcome measured is survival at 36 months. Participants must provide informed consent and undergo follow-up to assess disease status and survival over the study period, which extends until 2030.

Researchers are evaluating the safety and effectiveness of Fertilo compared to Medicult IVM for in vitro maturation IVM of eggs in women aged 18 to 35. The study aims to determine if Fertilo leads to more ongoing pregnancies at 12 weeks gestation than the currently approved Medicult IVM system. This is a phase III randomized control trial sponsored by Gameto, Inc.

This research aims to evaluate patient outcomes following shoulder replacement surgery using FX Shoulder Solutions medical devices. The study observes patients who have received these legally marketed devices in the USA to assess their safety, effectiveness, and long-term survivorship. The registry collects data to support regulatory requirements and share findings through presentations and publications. Participants are those implanted with FX Shoulder Solutions shoulder replacement devices, including various systems like Humelock II and Easytech Anatomical Shoulder System. The registry tracks these patients from surgery onward, with key follow-ups at 2 years to assess clinical success and up to 10 years to monitor device survivorship. Success is defined by measures such as improved shoulder function, no device migration, no revision surgery, and absence of serious device-related adverse events. During the study, patients undergo evaluations at multiple time points including 6 weeks, 3, 6, 12, and 24 months post-surgery using standardized scores like Adjusted Constant Score, QuickDASH, and Visual Analog Scale. Radiographic reviews, range of motion assessments, and tracking of adverse events and secondary surgeries occur up to 5 years. The study involves ongoing monitoring to understand the long-term performance and safety of the shoulder replacement devices.

Researchers are evaluating the effects of human menopausal gonadotropin hMG in women diagnosed with infertility undergoing Assisted Reproductive Technology ART cycles. This phase 3, multicenter, randomized, placebo-controlled, double-blind study aims to assess the efficacy and safety of hMG in developing multiple follicles, achieving pregnancy, and increasing cumulative live birth rates over a 12-month period. Participants will receive either daily subcutaneous injections of hMG or a placebo. The study involves up to two ovarian stimulation cycles followed by frozen embryo transfer FET. Researchers will monitor hormone levels, number and quality of oocytes, fertilization rates, blastocyst formation, and pregnancy milestones through various laboratory and imaging assessments. During the trial, participants will undergo regular evaluations including ultrasounds, blood tests for hormone measurements, and embryo biopsies. Researchers will track pregnancy progress through serum hCG tests and ultrasound confirmations of fetal heartbeat. The study follows participants for outcomes such as live birth rates up to nine months after embryo transfer. Participants must comply with study procedures and provide delivery and neonatal health data for the study duration.