Novy Jicin 1

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are investigating new treatments for people with proficient mismatch repair pMMR endometrial cancer that is advanced or has returned after surgery. This cancer starts in the tissues inside the uterus and has spread locally or to other parts of the body, making it not removable by surgery. The study aims to learn if combining sacituzumab tirumotecan sac-TMT with pembrolizumab helps people live longer and without their cancer worsening compared to pembrolizumab alone. All participants first receive an Induction Phase of six cycles, each lasting three weeks, which includes pembrolizumab combined with carboplatin or cisplatin and paclitaxel or docetaxel. Those whose cancer does not progress then enter a Maintenance Treatment Phase and are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer progresses, participants may enter a Subsequent Treatment Phase where they are randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During maintenance and subsequent phases, sac-TMT is given on Days 1, 15, and 29 of each 6-week cycle, and pembrolizumab is given on Day 1 of each 6-week cycle. Participants are involved throughout the study, receiving intravenous treatments over several months and up to 14 maintenance cycles lasting about 19 months. Researchers will monitor cancer progression and survival up to approximately 44 to 54 months. They also assess safety by tracking adverse events and quality of life using questionnaires. The study requires regular visits for treatment and evaluation over this period to understand how well the treatments work and their effects on participants.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

Researchers are conducting a three-part Phase 3 clinical trial to evaluate a potential new medicine called Sofetabart Mipitecan Sofe-M in people with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancers. The study focuses on patients with platinum-resistant cancer in Part A, meaning their disease worsened during or within six months of platinum-based chemotherapy, and platinum-sensitive cancer in Parts B and C, where disease remained controlled for more than six months after platinum treatment. The goal is to assess whether Sofe-M works better than current standard treatments and to understand its safety. Participants receive treatments administered intravenously. Part A compares Sofe-M to investigators choice of chemotherapy or Mirvetuximab Soravtansine MIRV. Parts B and C compare Sofe-M plus bevacizumab to platinum-based doublet chemotherapy plus bevacizumab. The study includes multiple chemotherapy options such as paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Each participants involvement duration depends on their response to treatment. During the trial, participants undergo regular assessments including imaging to measure progression-free survival and overall survival. Researchers also track tumor marker responses, side effects, quality of life scores, and pharmacokinetics of Sofe-M. The study uses a randomized design without masking. Follow-up can last up to about 70 months, allowing for long-term safety and effectiveness monitoring.