Teratoma

Researchers are investigating new treatments for advanced ovarian cancer that is non-HRD positive. The study aims to find out if maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, helps people live longer without their cancer worsening compared to standard care. This is a phase 3 trial involving participants who have completed surgery and first-line platinum-based chemotherapy. Participants will be assigned randomly to one of two groups. One group will receive sac-TMT infusions every two weeks on days 1, 15, and 29 of a six-week cycle, potentially combined with bevacizumab infusions every three weeks on days 1 and 22 for up to 22 cycles. The other group will receive either bevacizumab alone on the same schedule or be observed without treatment, depending on their assigned standard care option. Treatment continues until cancer progression, unacceptable side effects, or other reasons to stop. During the trial, participants will have regular visits for treatment and monitoring, including assessments of cancer progression and side effects. Researchers will measure how long participants live without cancer worsening (progression-free survival) for up to about 49 months and monitor overall survival and quality of life for up to about 78 months. Various health questionnaires will be used to track physical function, symptoms, and well-being. Safety and treatment tolerability will also be carefully evaluated throughout the study 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 test's 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 test's 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 test's ability to predict cancer risk accurately before surgery.

This research aims to provide continued access to the drug niraparib and further understand its long-term safety in participants who are currently being treated with niraparib in previous GlaxoSmithKline/TESARO-sponsored studies that have completed their main goals. The study includes adults with ovarian or breast cancers who are benefiting from niraparib treatment as judged by their doctor. Participants will take niraparib once daily by mouth continuously in 90-day cycles. The dose will be the same as what they received in their prior study. They will continue treatment until disease progression, unacceptable side effects, starting a new anticancer therapy not part of the previous study, withdrawal of consent, or other reasons decided by the doctor or participant. During the study, participants will attend scheduled visits where researchers will monitor side effects, physical health including vital signs and physical exams, lab tests, and overall wellbeing up to five years. They will track adverse events, changes in performance status, blood tests, and use of other medications. This long-term follow-up helps collect important safety information while participants continue niraparib treatment under medical supervision.

Researchers are investigating the safety, tolerability, how the body processes and responds to BGB-B2033, and its anti-tumor activity when given alone or with tislelizumab, with or without bevacizumab. This first-in-human study focuses on participants with advanced or metastatic solid tumors including hepatocellular carcinoma (HCC), alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors or non-dysgerminomas, and glypican-3-positive squamous non-small cell lung cancer (NSCLC). The study aims to understand these treatments in these specific cancers and is sponsored by BeOne Medicines. The study includes multiple parts: dose escalation of BGB-B2033 alone, combination treatments with tislelizumab and sometimes bevacizumab, and safety expansions for each therapy group. Participants receive the drugs by intravenous infusion. Different cohorts will evaluate dose levels to find the recommended dose for future studies, including groups in Asian countries and the United States focusing on HCC. This design helps assess the best doses and combinations to advance treatment understanding. Participants will undergo safety monitoring for adverse events and serious adverse events for up to approximately two years. Researchers will measure tumor responses through overall response rates assessed by independent review and investigators, duration of response, disease control rate, progression-free survival, and overall survival. Blood samples will be taken to study drug levels and immune responses. Tumor tissue samples are required for some parts. The study involves regular evaluations to monitor health, treatment effects, and laboratory measures throughout the participation period.

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 I/II 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 evaluating the rate of venous thromboembolism (VTE) over six months in participants with advanced germ cell cancer who are at high risk of VTE. The study focuses on those receiving standard cisplatin-based chemotherapy combined with low-dose acetylsalicylic acid (ASA). This Phase II, single-arm trial compares results to historical data to understand how well ASA may prevent VTE in this specific population. Participants will self-administer a fixed daily dose of 81 mg ASA by mouth for 26 weeks alongside their chemotherapy. The study has two stages: initially, 13 participants will be enrolled, and if most do not experience VTE during the first 26 weeks, an additional 18 participants will join. If a participant develops VTE, they will stop ASA and start standard anticoagulation treatment. The trial is initially conducted at a single center with plans to add more sites later. During the study, participants will be closely monitored for VTE events and bleeding complications. Researchers will assess VTE occurrence at 26 weeks, and secondary outcomes include major and non-major bleeding events, relapse-free survival, and overall survival up to two years after starting chemotherapy. Participants will provide their own ASA supply and are expected to comply with daily medication and study procedures throughout the trial duration.

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, both alone and combined with other drugs—nivolumab, docetaxel, or pumitamig—in people with advanced solid tumors. This is a first-in-human study aiming to understand the safety, tolerability, and best doses of BMS-986340 in this population. The study includes adults with various advanced cancers who have previously received standard treatments. Participants receive BMS-986340 as monotherapy or in combination with one of the other drugs. The study is organized into several parts including dose escalation and dose expansion phases for both monotherapy and combination therapies. Each treatment is given on specified days, with careful monitoring of drug levels and immune responses over time. Throughout the study, participants undergo tumor biopsies and regular assessments to measure treatment effects and side effects. Researchers track adverse events, serious side effects, and any issues leading to treatment changes or discontinuation. Outcome measures include tumor response rates and progression-free survival, monitored up to 120 weeks. The study involves safety monitoring, pharmacokinetic evaluations, and disease assessments at regular intervals to gather comprehensive data on the treatments.

Researchers are evaluating DM002, a bispecific antibody-drug conjugate designed to target MUC1 and HER3, in people with advanced solid tumors such as ovarian, prostate, endometrial, colorectal cancers, and other solid carcinomas. The study is divided into two parts: Part 1 focuses on testing increasing doses to find the safest and most effective amount, while Part 2 uses the best dose from Part 1 to further assess safety and how the cancer responds. This Phase I, open-label trial aims to understand how the body processes DM002 and to monitor any side effects at different dose levels. Participants will receive DM002 as an intravenous infusion once every three weeks, with doses ranging from 1.0 mg/kg up to 7.5 mg/kg. Part 1 involves dose escalation across up to six or more groups to evaluate safety and tolerability. In Part 2, participants receive the selected optimal dose determined from Part 1. The treatment cycles last 21 days each, and dose adjustments may occur based on safety and pharmacokinetic data. DM002 is provided as a sterile lyophilized powder for infusion. Participants will attend at least 17 visits, starting with a screening phase lasting up to 28 days. Treatment cycles occur every 21 days, followed by an End of Treatment visit 21 days after the last dose and a Follow-up visit 30 days later. Telephone check-ins will continue every three months to monitor wellbeing and any new anticancer treatments started. Researchers will measure dose-limiting toxicities, maximum tolerated dose, drug levels in the blood, and cancer response using objective measures over 12 months.