Study of Disitamab Vedotin and Pembrolizumab for Patients with Untreated Advanced Urothelial Cancer Expressing HER2
This multi-country trial compares disitamab vedotin plus pembrolizumab against standard chemotherapy for patients with HER2-expressing advanced urothelial cancer who haven't received prior treatment.
Main inclusion criteria: Patients must be 18 or older with locally advanced or metastatic urothelial carcinoma showing HER2 expression. Measurable disease and adequate organ function are required. Good performance status (ECOG 0-2) is necessary, with specific criteria for those ineligible for certain chemotherapy.
Main exclusion criteria: Previous treatment for advanced cancer (except if it returned more than 12 months after adjuvant therapy), another recent cancer, serious heart problems, active infections, pregnancy, or breastfeeding exclude participation. Allergies to study drugs and certain medical conditions also disqualify patients.
Trial focus: The study evaluates whether disitamab vedotin combined with pembrolizumab is more effective than standard chemotherapy. Researchers will monitor tumor response, progression-free survival, and safety throughout the trial.
Investigational drugs: Disitamab vedotin targets HER2 proteins on cancer cells, delivering medication directly to them. Pembrolizumab blocks PD-1, helping the immune system recognize and attack cancer cells. Both are given through intravenous infusion.
Study of IMC-F106C alone and with checkpoint inhibitors in patients with advanced PRAME-positive cancers who have HLA-A*02:01
This trial studies IMC-F106C (brenetafusp) for treating advanced PRAME-positive cancers in patients with HLA-A*02:01. The medication is tested both alone and combined with checkpoint inhibitors.
Main inclusion criteria: Patients must be 18 or older with good performance status (ECOG 0 or 1). They must have HLA-A*02:01 positive status and PRAME-positive tumors. The cancer should have returned after treatment or not responded to standard therapies.
Main exclusion criteria: Prior PRAME-targeted therapy, active or untreated brain metastases, severe allergic reactions to antibody treatments, significant heart problems, uncontrolled infections, HIV, Hepatitis B or C, pregnancy, breastfeeding, other active cancers, recent major surgery, or participation in another trial within four weeks exclude patients.
Trial focus: The study has two phases: Phase 1 determines the safest and most effective dose, while Phase 2 evaluates how well the treatment works in specific tumor types. Regular monitoring includes blood tests and imaging to measure response.
Investigational drug: IMC-F106C targets PRAME proteins on cancer cells, helping the immune system recognize and attack them. It can be given intravenously or subcutaneously.
Study of Tulmimetostat (CPI-0209) for Patients with Advanced Solid Tumors and Lymphomas
This trial tests CPI-0209 (tulmimetostat) for various advanced cancers including urothelial carcinoma, ovarian clear cell cancer, endometrial carcinoma, mesothelioma, and prostate cancer.
Main inclusion criteria: Participants must be 18 or older with advanced or metastatic solid tumors or lymphomas that have returned or worsened after standard treatment. A life expectancy of at least 12 weeks, tumor samples for testing, adequate organ function, and recovery from previous treatment side effects are required.
Main exclusion criteria: Patients not fully recovered from previous treatments, with other serious health conditions, pregnant or breastfeeding, with another cancer within five years (except certain skin cancers), participating in another trial, with known allergies to study medication, active infections requiring treatment, certain heart conditions, uncontrolled high blood pressure, drug or alcohol abuse, recent live vaccines, certain blood disorders, autoimmune diseases, organ transplants, or brain/spinal cord conditions cannot participate.
Trial focus: Phase 1 finds the maximum tolerated dose, while Phase 2 assesses antitumor activity. The study monitors tumor response, progression-free survival, and overall survival throughout the trial period.
Investigational drug: CPI-0209 is taken orally as a film-coated tablet. It works by inhibiting specific proteins involved in cancer cell growth and survival.
Study of TYRA-300 for Patients with Advanced Bladder Cancer and Other Solid Tumors with FGFR3 Gene Changes
This trial studies TYRA-300 for advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations.
Main inclusion criteria: Patients must be 18 or older with a life expectancy exceeding 12 weeks and good performance status (ECOG 0-2). They must have confirmed advanced solid tumors with activating FGFR3 gene alterations, ability to swallow oral medications, at least one measurable lesion, and adequate organ and bone marrow function.
Main exclusion criteria: Patients with cancers other than those specified, outside the age range, unable to follow procedures, or in vulnerable populations cannot participate.
Trial focus: Phase 1 determines the optimal dose, while Phase 2 evaluates effectiveness. Regular monitoring includes safety assessments, tumor response measurements, and quality of life evaluations.
Investigational drug: TYRA-300 is taken orally as capsules or tablets. It works by inhibiting FGFR3 protein activity, which is involved in cancer cell growth and division.
Study of V940 and Pembrolizumab for Patients with High-Risk Muscle-Invasive Bladder Cancer After Surgery
This trial tests V940 (mRNA-4157) combined with pembrolizumab versus pembrolizumab alone for preventing cancer recurrence after surgery in high-risk muscle-invasive urothelial carcinoma patients.
Main inclusion criteria: Patients must have muscle-invasive urothelial carcinoma with high-risk features after surgery. Tumor tissue and blood samples are required for V940 production. Good performance status (ECOG 0-2) is necessary within seven days before starting treatment.
Main exclusion criteria: Patients not fully recovered from previous treatments, with other active cancers, severe heart problems, uncontrolled high blood pressure, active infections, pregnancy, breastfeeding, severe allergic reactions to similar medications, autoimmune diseases, organ transplants, or drug/alcohol abuse cannot participate.
Trial focus: The study compares disease-free survival between the combination therapy and pembrolizumab alone. Participants will be randomly assigned to treatment groups and monitored regularly through 2032.
Investigational drugs: V940 is an mRNA-based therapy teaching the immune system to recognize and attack cancer cells. Pembrolizumab blocks PD-1, allowing immune cells to better detect and fight cancer. Both are given through intravenous infusion.
Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
This trial tests BAY 2927088 for advanced solid tumors with HER2 mutations, including bladder and urinary tract cancers.
Main inclusion criteria: Patients must be 18 or older with advanced solid tumors that cannot be removed surgically and have HER2 mutations. At least one measurable tumor is required. Previous standard treatments must have been tried, or no satisfactory alternatives exist.
Main exclusion criteria: Patients without HER2 mutations, outside the age range, unwilling or unable to follow procedures, pregnant, breastfeeding, with certain medical conditions, recently participating in another trial, with allergies to study medication, active infections, certain heart conditions, uncontrolled high blood pressure, drug or alcohol abuse, recent live vaccines, certain blood disorders, autoimmune diseases, organ transplants, or brain/spinal cord conditions cannot participate.
Trial focus: The study evaluates objective response rate, safety, quality of life, and survival. Regular monitoring includes imaging tests, blood work, and safety assessments throughout the trial period extending to 2027.
Investigational drug: BAY 2927088 is taken orally as coated tablets. It works as a reversible tyrosine kinase inhibitor, blocking proteins that help cancer cells grow.
Summary
These 30 clinical trials represent a significant research effort across Europe investigating new treatments for transitional cell carcinoma. Several notable patterns emerge from this overview:
Geographic concentration: France, Italy, Spain, and Germany host the most trials, reflecting robust clinical research infrastructure in these countries. Several trials are available in multiple European countries, providing wider access for patients.
Treatment approaches: The majority of trials focus on immunotherapy combinations, particularly using checkpoint inhibitors like pembrolizumab, nivolumab, and atezolizumab. Many studies combine these with targeted therapies or chemotherapy to improve outcomes.
Targeted populations: Trials address various disease stages, from high-risk post-surgical patients to those with advanced or metastatic disease. Some studies specifically target patients with particular molecular markers like HER2 expression or FGFR3 mutations.
Innovative medications: Several trials test novel antibody-drug conjugates (BT8009, disitamab vedotin, ifinatamab deruxtecan, raludotatug deruxtecan) that deliver chemotherapy directly to cancer cells. mRNA-based therapies like V940 represent cutting-edge approaches.
Patients interested in participating should discuss eligibility with their healthcare providers, as these trials may offer access to promising new treatments while contributing to advancing medical knowledge about transitional cell carcinoma treatment.
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