Iizuka

Researchers are evaluating the safety and effectiveness of new treatments called BNT314 and BNT327 combined with chemotherapy for people with metastatic colorectal cancer (mCRC) that is microsatellite stable or mismatch repair proficient (MSS/pMMR). This study includes participants who did not respond well to their first chemotherapy treatment and aims to find the right dose and assess how well these treatments work together to shrink tumors or slow their growth. The study includes multiple phases to test safety, dosing, and treatment benefits. The study has three parts: Part A focuses on safety and dose escalation of BNT314 with BNT327; Part B tests the safety and optimal dose of BNT314 combined with BNT327 and standard chemotherapy; and Part C compares the combination treatment with standard chemotherapy alone to see if it improves outcomes. Treatments are given by intravenous infusion or oral methods depending on the drug. Participants receive treatment until their disease worsens, they cannot tolerate the therapy, or the study ends, with an average treatment duration of 6 to 10 months. Participants will be screened, treated, and followed up for safety and long-term survival. Researchers will regularly monitor for side effects, treatment response, and disease progression using scans and laboratory tests. The study includes a safety follow-up period and a long-term survival follow-up that can last up to 57 months, with committees overseeing participant safety throughout the trial.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

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 conducting a master protocol study called CAMPFIRE to efficiently carry out multiple clinical trials testing new drugs in children and young adults with cancer. This master protocol allows for adding new studies as new cancer drugs become available, focusing on the treatment of measurable or evaluable tumors in participants aged 1 to 39 years. The goal is to evaluate various drugs under a unified research plan to improve treatment options for young cancer patients. The study involves several investigational drugs administered either intravenously or orally, including Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel, Abemaciclib, Irinotecan, and Temozolomide. Each drug is tested under specific clinical trials within the master protocol, with treatment schedules and dosing tailored to each drug. Participants receive these treatments following standard clinical procedures, with adjustments based on individual study protocols and treatment responses. Participants will be closely monitored throughout the trial, with assessments including performance status evaluations, laboratory tests to check organ and blood function, and pregnancy testing for females of childbearing potential. Researchers will track how many participants receive each treatment during the first four weeks and observe the duration of treatment benefits. Safety evaluations, adherence to contraceptive measures, and recovery from prior therapies are also part of the study monitoring. Participation duration and additional assessments depend on the specific trial and treatment plan assigned.

Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are conducting a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab with investigator's choice monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who have incurable metastatic or recurrent disease. This study focuses on patients with progressive disease after anti-PD-1 therapy and platinum-containing therapy and aims to evaluate the treatments as second- or third-line options. Participants will receive either petosemtamab or one of the investigator's choice monotherapies, including cetuximab, methotrexate, or docetaxel. The study involves treatment administration under controlled conditions with monitoring for efficacy and safety. The goal is to assess the treatments over time with a focus on response rates and overall survival. During the study, participants will undergo regular assessments including radiologic imaging to measure tumor response, and evaluations of overall survival up to approximately three years. The primary outcomes include objective response rate assessed by blinded independent central review and overall survival. Researchers will monitor patient health, side effects, and treatment effectiveness throughout the study duration.

Researchers are evaluating a new compound called AZD8205 as a potential treatment for advanced or metastatic solid tumors, either alone or combined with other anti-cancer drugs. This Phase I/IIa multi-center, open-label study focuses on patients with advanced solid tumors including breast cancer, biliary tract cancer, ovarian cancer, endometrial cancer, and squamous non-small cell lung cancer. The study aims to understand the safety and effects of AZD8205 and its combinations in these patient populations. Participants may receive AZD8205 alone or combined with other agents such as rilvegostomig, a bispecific antibody targeting TIGIT and PD-1; saruparib, a PARP inhibitor; or AZD9574, another PARP inhibitor. Various combinations include AZD8205 with rilvegostomig, saruparib, both saruparib and rilvegostomig, or AZD9574 with or without rilvegostomig. The study uses dose escalation and expansion phases to assess these treatments. Treatment is given according to the assigned group, with dosing schedules and combinations tailored to evaluate safety and tolerability. During the study, participants will be closely monitored for safety including adverse events, serious adverse events, and dose-limiting toxicities. Laboratory tests, ECGs, and vital signs will be regularly checked from the time of informed consent through 30 days after the last dose, covering about one year in total. Researchers will also assess measurable disease response and overall health status. This comprehensive evaluation helps determine the potential of AZD8205 and its combinations as treatments for advanced solid tumors.