Massillon

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating the safety and effectiveness of gotistobart ONC-392BNT316, a next-generation anti-CTLA-4 antibody, in patients with metastatic non-small cell lung cancer NSCLC whose disease has progressed after treatment with anti-PD-1 or PD-L1 antibody-based therapies. This Phase 3 clinical trial aims to compare gotistobart with the chemotherapy drug docetaxel to see if it can help prolong life in these patients. Approximately 630 patients will participate, and the study is divided into two stages to confirm dosing and assess outcomes. In Stage I, two dosing regimens of gotistobart will be tested against docetaxel, which is given at 75 mgm2 every 21 days. Gotistobart will be administered by intravenous infusion over 60 minutes every 21 days, either at 3 mgkg or 6 mgkg with two loading doses of 10 mgkg. After selecting the most appropriate dosing regimen, Stage II will compare that gotistobart dose with docetaxel in patients with squamous cell NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will receive regular infusions and be monitored for overall survival over 36 months, along with secondary outcomes like tumor response, progression-free survival, and treatment-related adverse events. Patients must have measurable tumors and meet specific health criteria before joining. The study includes safety monitoring and ongoing assessments to evaluate how well the treatments are tolerated and their effects on cancer progression.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are collecting real-world clinical and patient-reported data from individuals with breast, lung, ovarian, multiple myeloma, or acute myelogenous leukemia AML who are undergoing active treatment. The study uses an electronic care planning system that includes remote symptom monitoring to gather information as part of routine care. The purpose is to add this data to Carevives registry to better understand patient experiences during treatment. Participants complete a baseline survey either in person on a secure device or remotely using their own electronic device. Following this, they receive weekly electronic patient-reported outcome surveys through the Carevive platform for at least 12 weeks, with the option to continue weekly surveys while still receiving treatment. The intervention involves completing these web-based surveys to track symptoms and treatment experiences. During the study, participants regularly provide information through surveys completed on phones, tablets, or computers. Researchers collect and analyze this data over the course of a year to create a comprehensive data set. The study monitors patient responses and treatment experiences remotely, allowing participants to contribute from a location of their choice. This approach supports ongoing symptom tracking and data collection throughout treatment.

Researchers are evaluating the benefits and safety of adding sacituzumab tirumotecan to pembrolizumab compared to treatment chosen by a physician in adults with triple-negative breast cancer TNBC who have already received pre-surgery therapy but did not achieve a complete response at surgery. This Phase 3, randomized, open-label trial aims to see if the combination treatment improves invasive disease-free survival compared to current standard options. The study is sponsored by Merck Sharp & Dohme LLC and focuses on patients who need additional therapy after surgery. Participants in one group receive sacituzumab tirumotecan by intravenous infusion every two weeks combined with pembrolizumab every six weeks for a total of 24 weeks. They also receive pre-medication such as antihistamines, H2 antagonists, acetaminophen, and dexamethasone before sacituzumab tirumotecan infusions. The comparison group receives pembrolizumab every six weeks alone or with oral capecitabine twice daily on specific schedules for 24 weeks. The study uses random assignment to these treatment groups and follows participants for long periods. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess invasive disease-free survival for up to about 77 months and track overall survival, recurrence, and quality of life measures for up to around 101 months. Safety will be monitored by recording adverse events and any treatment discontinuations due to side effects. The study includes detailed evaluations of physical functioning, fatigue, and role functioning using questionnaires. Participation lasts several years with ongoing assessments to evaluate long-term outcomes and safety.