Teratoma

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

Researchers are conducting a multicenter observational study to understand hereditary ovarian cancer among Chinese patients. The study aims to describe the clinical and genetic features of hereditary ovarian cancer and establish a risk prediction model to estimate cancer risk in first-degree relatives of mutation carriers. It also seeks to identify new tumor-causing mutations in families with hereditary ovarian cancer where known genetic causes are not found. Participants include patients diagnosed with epithelial ovarian cancer, divided into two groups those with suspected gene mutations or a family history of cancer, and those without these factors. The study will follow these groups from 2024 to 2026 to analyze clinical, pathological, and genetic information. Through genetic sequencing and family history, the research team will explore new genetic mechanisms and verify the risk prediction model. Participants will undergo genetic testing and clinical evaluations over the study period from 2024 to 2026. Researchers will collect data on tumor features, gene mutations, and family histories. The primary outcome is to describe clinicopathological and genetic characteristics of hereditary ovarian cancer. Secondary outcomes include monitoring new ovarian cancer cases in first-degree relatives. The study aims to guide personalized diagnosis, treatment, and preventive interventions for high-risk families.

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics CleoDX Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the tests accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the tests score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the tests ability to predict cancer risk accurately before surgery.

This research aims to provide continued access to niraparib and to further assess its long-term safety in participants with ovarian or breast neoplasms who are currently receiving niraparib treatment within previous GlaxoSmithKlineTESARO-sponsored studies. It focuses on participants who have completed earlier studies where the primary objectives were met and are judged by their doctors to still benefit from niraparib. The study is a phase 2, open-label extension trial designed to monitor treatment continuation and safety over time. Participants will receive niraparib once daily by mouth, following the same dose and schedule as in their previous parent study. Treatment is organized in 90-day cycles and will continue until disease progression, unacceptable side effects, new anticancer therapy unrelated to the parent study, withdrawal, or other reasons for discontinuation occur. The dosing regimen mirrors what was assigned in the prior study, ensuring consistency for each participant. During the study, participants will have regular evaluations to monitor safety and health status for up to five years. These assessments include tracking adverse events, serious side effects, and specific safety concerns, as well as monitoring physical exams, vital signs, blood tests, and medication use. Participants must comply with scheduled visits and treatments while using effective contraception if of childbearing potential. The study duration and follow-up are designed to gather detailed long-term safety information on niraparib treatment.

Researchers are evaluating the safety, tolerability, how the body processes and responds to the drug, and the anti-tumor activity of BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with locally advanced or metastatic solid tumors including hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors, and glypican-3-positive squamous non-small cell lung cancer. The trial aims to determine safe dosage levels and preliminary effectiveness in these advanced cancer types. Participants receive intravenous infusions of BGB-B2033 either alone or combined with tislelizumab and bevacizumab in several dose escalation and expansion cohorts. The study includes ascending doses of BGB-B2033 monotherapy, combination therapies to find maximum tolerated doses and recommended doses for further testing, and safety expansion groups. Some participants are from Asian countries and others from the United States, focusing on hepatocellular carcinoma in these regions. Throughout the study, participants are closely monitored for adverse events and responses to treatment for up to approximately 2 years. Assessments include safety evaluations, measuring tumor responses by independent review and investigators, pharmacokinetic and pharmacodynamic tests, and antibody development against the study drug. Tumor tissue samples are required for certain parts of the study. This comprehensive follow-up helps researchers understand the study drugs activity and safety in advanced cancers.

Researchers are evaluating UCB4594, a monoclonal antibody designed to target human leucocyte antigen G HLA-G, a protein found in high levels on some cancer cells. This Phase III clinical trial aims to find the safest and most effective dose of UCB4594, understand its side effects and how to manage them, study how the drug behaves in the body, and assess whether it can shrink cancer. The trial focuses on participants with advanced solid tumors that express HLA-G and are resistant to conventional treatments. The trial is divided into two phases. Phase I Module A involves dose escalation where small groups receive increasing doses of UCB4594 given as an intravenous infusion every three weeks for up to 18 cycles about one year. Phase II includes dose expansion with UCB4594 given alone Module B or combined with other anti-cancer drugs Module C to further study its effects. Module C details will be added once specific cancers and combination treatments are defined. Participants will undergo regular assessments including biopsies and radiological scans to measure tumor response and drug levels in the body. Researchers will monitor safety by tracking adverse events from consent through up to 12 months after treatment. The study includes detailed follow-up for up to 13 months to evaluate how the drug is processed and how it impacts cancer. The total participation period may last approximately one year or more depending on treatment cycles and assessments.

Researchers are studying adults with advanced germ cell cancer who are at high risk for venous thromboembolism VTE. The study aims to evaluate the rate of participants who remain free of VTE for six months while receiving standard cisplatin-based chemotherapy combined with low-dose aspirin acetylsalicylic acid, ASA, comparing outcomes to historical data. This is a single-arm Phase II trial involving participants with stage IS or IIA or higher testicular or germ cell cancer. Participants will take a fixed low dose of aspirin 81 mg orally every day for 26 weeks alongside their standard chemotherapy. The study is designed in two stages first enrolling 13 participants, with expansion to a total of 31 if initial results show promising VTE prevention. Participants provide their own aspirin supply and will stop aspirin if they experience a VTE, switching to standard anticoagulation therapy as directed by their doctors. During the study, participants will be monitored for VTE events and bleeding risks over 26 weeks. Researchers will also assess relapse-free survival and overall survival up to two years after starting chemotherapy. Participants must be able to swallow oral medications and comply with study procedures throughout the treatment period. This study is sponsored by Wake Forest University Health Sciences and may include additional sites beyond the initial center.

Researchers are investigating the best way to combine chemotherapy and radiation therapy for patients aged 3 to 29 years with localized non-germinomatous germ cell tumors NGGCT in the brain. This phase II trial aims to optimize treatment based on how well the tumor responds to initial chemotherapy, with the goal of reducing spinal cord relapses and adjusting therapy for better disease control. The study also compares different radiation types and examines cognitive and physical effects in children and young adults with NGGCT. Participants first receive induction chemotherapy consisting of carboplatin, etoposide, and ifosfamide over six cycles every 21 days. Based on tumor response, patients are assigned to one of two plans Plan A involves whole ventricular plus spinal canal irradiation WVSCI, delivered daily for 6 weeks, while Plan B includes high-dose chemotherapy with stem cell transplant followed by radiation therapy to the whole brain and spine. Some patients may undergo second-look surgery depending on tumor response before continuing treatment. Throughout the study, participants undergo MRI scans, collection of cerebrospinal fluid and blood samples, and questionnaires assessing cognitive, social, and behavioral functioning. Researchers monitor tumor response, progression-free survival, overall survival, and patterns of disease recurrence for up to 10 years. Safety and side effects are also evaluated to better understand long-term outcomes of these treatment approaches.

Researchers are evaluating BMS-986340 alone and combined with nivolumab, docetaxel, or pumitamig in people with advanced solid tumors. This first-in-human study aims to assess the safety, tolerability, and recommended doses of BMS-986340 in participants with various advanced cancers who have progressed after standard treatments. This study includes different phases and treatment parts to explore dosing and effects. Participants receive BMS-986340 either as monotherapy or combined with nivolumab, docetaxel, or pumitamig at specified doses on scheduled days. The study includes dose escalation and expansion phases for each treatment combination. The treatments are given sequentially, with participants assigned randomly to different parts of the study to evaluate safety and dosing. During the trial, participants undergo tumor biopsies for biomarker analysis and have measurable disease per standard criteria. Researchers monitor adverse events, serious side effects, and dose-limiting toxicities up to 120 weeks. Pharmacokinetics, immune responses, and tumor responses are regularly assessed. Participants are followed for safety, disease control, and progression-free survival for up to 120 weeks.

Researchers are evaluating DM002, an investigational bispecific antibody-drug conjugate targeting MUC1 and HER3, in adults with advanced solid tumors such as ovarian, prostatic, endometrial, colorectal, and pancreatic cancers. This study has two parts Part 1 focuses on finding the safest and most effective dose through dose escalation, while Part 2 expands the evaluation at the best dose found in Part 1 to further assess safety and cancer response. Participants receive DM002 through intravenous infusion on Day 1 every three weeks. Part 1 involves up to six or more dose levels tested sequentially to determine safety and optimal dosing. In Part 2, participants receive the recommended dose established from Part 1. Dose adjustments may occur based on safety and pharmacokinetic data. The treatment cycles last 21 days each. Participants will have at least 17 visits, including a screening phase lasting up to 28 days, treatment cycles every 21 days, an End of Treatment visit 21 days after the last dose, and a Follow-up visit 30 days later. Phone contacts will continue every three months to monitor well-being and any new anticancer therapies started. Researchers will monitor dose-limiting toxicities, maximum tolerated dose, drug levels in the body, and tumor response throughout the 12-month study period.