Niles

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety, tolerability, and effectiveness of EIK1001 combined with standard treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received vein-based treatment for their advanced disease. This phase 2, open-label, multicenter trial includes participants with confirmed stage 4 squamous or non-squamous NSCLC without mutations suitable for first-line targeted therapy. The study aims to find appropriate dosing and monitor adverse events alongside treatment response. Participants receive EIK1001, a Toll-like receptor 7/8 agonist, together with pembrolizumab, a PD-1 inhibitor, and chemotherapy drugs such as paclitaxel, pemetrexed, or carboplatin. These treatments are combined as part of the standard care for stage 4 NSCLC. The trial assesses safety and efficacy over the treatment period, including a dose-finding phase to determine the best dose of EIK1001. During the study, participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, organ function tests, and monitoring of performance status. Researchers track the percentage of participants experiencing safety events throughout up to two years of treatment. Follow-up includes ongoing evaluation of side effects and effectiveness to understand the treatment impact and participant well-being over the course of the trial.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating alisertib monotherapy in patients with extensive stage small cell lung cancer (SCLC) who have already undergone treatment with a platinum-based chemotherapy and an anti-PD-L1 immunotherapy. This Phase 2 study aims to identify biomarker-defined subgroups that might benefit most from alisertib and to assess the drug's effectiveness, safety, and how it is processed by the body. Participants may have received up to two prior systemic anti-cancer therapies for SCLC. The study involves giving patients alisertib in the form of enteric-coated tablets. The study focuses on a specific group of patients who have progressed after previous treatments. There are no details provided about dosing schedules or additional treatment periods within the source. During the study, researchers will measure outcomes such as objective response rate, duration of response, disease control rate, progression-free survival, and overall survival, all assessed within biomarker-defined subgroups up to 36 months from the first dose. Participants will be monitored throughout this period to evaluate these outcomes and to observe safety and pharmacokinetics.

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 efficacy and safety of a drug called azenosertib (ZN-c3) in women with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study focuses on patients whose tumors test positive for Cyclin E1 protein, determined by a specific assay developed by the sponsor. The study aims to understand how well azenosertib works in this group and its safety profile. The study involves administering azenosertib orally to participants. It is divided into two parts: Part 1 included all patients regardless of biomarker status and has completed enrollment; Part 2 requires tumors to be Cyclin E1 positive. Participants receive azenosertib and are monitored throughout the study according to the protocol. Participants will be involved in various assessments including tumor measurements following RECIST version 1.1 criteria up to about 12 months after the last participant enrolls. Researchers will track the objective response rate to evaluate tumor response. Safety and efficacy evaluations, along with monitoring of side effects and overall health, will take place during the study period to gather comprehensive data on the 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 aims to evaluate the safety and effectiveness of zilovertamab vedotin (ZV) combined with standard treatments for participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). It is a Phase 2/3, randomized, open-label, multisite study including participants aged 18 and older. The study tests two main hypotheses: that ZV combined with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is better than R-GemOx alone for progression-free survival; and that ZV combined with bendamustine rituximab (BR) is better than BR alone. However, enrollment in the BR and ZV + BR arms is discontinued, so no outcome analysis will be done for those groups. The study is split into two parts: Part 1 confirms the dose of ZV, and Part 2 expands to evaluate its efficacy. Participants receive intravenous infusions of ZV at various doses, along with standard drugs including rituximab, gemcitabine, oxaliplatin, and bendamustine as appropriate. Prophylactic granulocyte colony-stimulating factor (G-CSF) is given with each ZV cycle according to institutional guidelines. Treatment schedules and doses are carefully managed to assess safety and treatment effects. During the study, participants will be monitored for dose-limiting toxicities up to about 6 weeks, and adverse events for up to approximately 68 months. Researchers will also track treatment discontinuations due to adverse events. Key outcomes include overall survival and progression-free survival up to about 35 months. Participants will have regular assessments including scans, clinical evaluations, and laboratory tests to measure response and monitor safety throughout their participation.

Non-small cell lung cancer (NSCLC) is a type of cancer where cells grow uncontrollably in the lung tissues. This study focuses on adults with previously treated non-squamous NSCLC that overexpresses the c-Met protein and have no activating mutations in the EGFR gene. The main goal is to evaluate the safety of an investigational drug called telisotuzumab vedotin and to monitor changes in disease activity and side effects over time. Participants will be randomly assigned to receive one of three different doses of telisotuzumab vedotin through an intravenous (IV) infusion. The study involves approximately 150 adult participants worldwide and lasts for about three years. During this time, participants will receive the treatment at regular intervals as part of the study protocol. Throughout the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, and questionnaires will be used to monitor treatment effects and side effects. Researchers will specifically track adverse events, including lung disease, nerve problems, eye disorders, and any reasons that might lead to stopping the study drug. The main outcomes include safety measures and tumor response evaluated by independent central review over the three-year period.