Goodyear

This research investigates how using cannabis (also known as marijuana, weed, or THC) affects the quality of life for patients with multiple myeloma who are undergoing chemotherapy. It aims to compare the experiences of cannabis users and non-users, focusing on potential benefits and harms related to cannabis use. The study uses specific tools like the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) and symptom assessments to better understand these effects over time. Participants are divided into two groups. One group completes surveys and provides blood samples regularly throughout the study, while healthcare providers complete separate surveys about their care practices. This observational study does not involve giving any new treatments but monitors patients receiving their usual cancer-directed therapies, including any cannabis use. During the study, patients complete questionnaires about their quality of life and symptoms, and medical professionals assess any side effects. The study measures outcomes over up to one year, tracking changes in quality of life and any therapeutic benefits or adverse effects linked to cannabis. Researchers monitor these factors through patient reports and medical evaluations to better understand the impact of cannabis in this patient group.

Researchers are evaluating the safety, tolerability, how the body processes, and the anti-tumor activity of a drug called BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human Phase 1 study includes participants who have locally advanced or metastatic hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors or non-dysgerminomas, and glypican-3-positive squamous non-small cell lung cancer. Participants will receive BGB-B2033 through intravenous infusion either alone or combined with tislelizumab, and sometimes with bevacizumab given by intravenous infusion as well. The study evaluates different dosing levels to find the maximum tolerated dose and the recommended dose for Phase 2. Treatment will be monitored over approximately two years in various parts of the study. During the study, participants will have tumor tissue samples collected and undergo assessments including safety monitoring for adverse events, evaluations of tumor response by an independent review committee, and tests to understand drug effects and dosing. The study will measure overall response rates and track safety and tolerability over up to about two years, with ongoing monitoring of health and treatment effects.

Researchers are studying bleximenib, an investigational drug taken orally, to find the best dose for treating acute leukemia and to evaluate its safety and effectiveness. In Phase 1, they aim to identify the recommended Phase 2 dose (RP2D) through a dose escalation and expansion process. Phase 2 will focus on assessing how well bleximenib works at the recommended dose in participants with relapsed or refractory acute leukemia, particularly those with specific genetic alterations in KMT2A, NPM1, or NUP98/NUP214. The study involves administering bleximenib orally and includes different participant groups based on age and disease status. Phase 1 includes pediatric participants aged 2 to less than 18 years and adults 18 years and older with relapsed or refractory acute leukemia who have limited treatment options. Phase 2 focuses on adults over 18 with relapsed or refractory acute myeloid leukemia harboring KMT2A or NPM1 mutations. The trial monitors participants for dose-limiting toxicities, adverse events, and treatment tolerability over periods lasting up to nearly five years. Participants will undergo evaluations of safety, including the number and severity of adverse events and dose-limiting toxicities during the first cycle. The effectiveness measure in Phase 2 is the rate of complete remission or remission with partial blood count recovery. Throughout the study, participants will be assessed using laboratory tests, performance status scales, and pregnancy tests as applicable. Safety monitoring and long-term follow-up will continue for up to 4 years and 9 months to fully evaluate treatment effects and tolerability.

Researchers are evaluating treatments for people with extensive stage small-cell lung cancer (ES-SCLC). This phase 3 study compares the effectiveness of adding tarlatamab to a combination of durvalumab, carboplatin, and etoposide against the combination without tarlatamab. The main goal is to see which treatment better prolongs overall survival and progression-free survival over about 3.5 years. Participants receive intravenous infusions of the study drugs. One group gets tarlatamab combined with durvalumab, carboplatin, and etoposide, while the other group receives durvalumab, carboplatin, and etoposide alone. All treatments are given as first-line therapy for their lung cancer. During the study, participants will be monitored regularly to assess their response to treatment and overall health. Researchers will measure overall survival and progression-free survival to evaluate treatment benefit. The study also involves ongoing safety monitoring, and participants will be followed for up to approximately 3.5 years to collect these outcomes.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-cancer effects of a new drug called BG-C477. The study includes participants with advanced solid tumors that have been previously treated or for whom no standard treatment exists. This trial is a Phase 1a/b, first-in-human study conducted by BeOne Medicines, formerly BeiGene, to better understand BG-C477 alone and combined with other cancer treatments. Participants will receive BG-C477 intravenously, either by itself or combined with other anticancer agents such as Tislelizumab or chemotherapy given according to local guidelines. The study includes dose escalation to find the maximum tolerated or administered dose, followed by dose expansion to evaluate recommended doses. This process may last up to approximately two years, with specific focus on safety, dosing, and preliminary effectiveness. During the study, participants will be monitored for side effects and treatment responses through clinical assessments, laboratory tests, and imaging to measure tumor changes. Researchers will collect samples from tumors and track adverse events from the first dose until 30 days after the last dose, with follow-up lasting up to two years. The primary outcomes include safety measurements, dose recommendations, and overall response rate to treatment.

Researchers are evaluating the combination of bleximenib, venetoclax (VEN), and azacitidine (AZA) compared to placebo with venetoclax and azacitidine alone in treating adults newly diagnosed with acute myeloid leukemia (AML) who have specific gene mutations (NPM1 or KMT2A) and are not eligible for intensive chemotherapy. This is a phase 3 randomized, double-blind, placebo-controlled study focusing on participants with AML harboring these genetic abnormalities. The study aims to assess treatment effectiveness by measuring complete remission rates and overall survival. Bleximenib and venetoclax are given orally, while azacitidine is administered either intravenously or under the skin. Participants will receive either the combination of bleximenib, venetoclax, and azacitidine or placebo with venetoclax and azacitidine, following a rigorous treatment schedule. The study includes an initial treatment period where the effects of these drugs are compared to determine their impact on AML with the given mutations. Participants will be closely monitored through regular assessments, including evaluations of remission status and survival over a period of up to 4 years and 1 month. Safety and treatment responses will be tracked throughout the study. Participants must consent to follow the study procedures and agree to contraception requirements during and after treatment. The trial involves continuous observation to gather comprehensive data on treatment outcomes and participant health.

This research evaluates two forms of carmustine, VI-0609 (carmustine with propylene glycol) and BiCNU (carmustine with ethanol), as part of the BEAM high-intensity chemotherapy conditioning regimen in adults with Hodgkin or Non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplantation (AHCT). The study is a phase 2 multicenter trial comparing these two drug formulations to understand their effects in lymphoma treatment. Participants receive either VI-0609 or BiCNU within the BEAM chemotherapy regimen before undergoing AHCT. Both drug forms are administered as part of the conditioning process designed to prepare patients for the transplant by reducing lymphoma cells. The study closely monitors infusion-related reactions and toxicity levels during and after treatment. During the trial, participants are assessed for infusion-related toxicities within 24 hours after receiving the drug and for unacceptable toxicities from the start of the BEAM regimen through 30 days post-transplant. Researchers track clinical and laboratory results including heart and lung function, and monitor overall patient safety. The study includes follow-up to evaluate the treatment impact and patient recovery over time.

Researchers are evaluating momelotinib to determine its safety and effectiveness in people with low-risk myelodysplastic syndromes (LR-MDS), a condition affecting blood cell production. This phase 2 study aims to find the best dose of momelotinib that may help reduce the need for red blood cell transfusions. The study also examines how the body processes momelotinib and its major metabolite. The study has two parts. In Part 1, participants receive varying doses of momelotinib to identify the optimal dose based on improvements in red blood cell transfusion needs and safety. In Part 2, participants receive the selected dose from Part 1 to further assess its effects on reducing transfusion dependence and to monitor safety. Momelotinib is given as a drug, and dosing and safety are closely tracked over the study period. Participants will be monitored for red blood cell transfusion independence lasting at least 12 weeks, safety events including severe side effects, and momelotinib blood levels. These assessments occur up to 24 weeks for transfusion outcomes and up to approximately 104 weeks for safety monitoring. The study also measures drug concentration and exposure in the blood to understand how momelotinib is processed. Overall, participant involvement includes treatment, regular safety evaluations, and blood tests to track outcomes and side effects over time.