Ongoing Clinical Trials for Bladder Cancer Stage II

This article provides information about an ongoing clinical trial for patients with Stage II bladder cancer, specifically muscle-invasive bladder cancer. The trial is investigating a combination of pembrolizumab with chemotherapy drugs cisplatin and gemcitabine, and is being conducted across multiple countries in Europe.

Clinical trial locations

• Belgium
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Denmark
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Espagne
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• France
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Germany
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Hungary
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Ireland
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Italy
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Poland
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Spain
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment
• Sweden
  • Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment

Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment

This clinical trial is investigating a treatment approach for patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy. The study combines an immunotherapy medication called pembrolizumab (also known as Keytruda) with two standard chemotherapy drugs, cisplatin and gemcitabine.

Main focus: The primary goal of this research is to determine whether adding pembrolizumab to standard chemotherapy before and after surgery can improve outcomes for patients compared to chemotherapy alone. Pembrolizumab is an immune checkpoint inhibitor that works by helping the body’s immune system recognize and attack cancer cells. The study will track how long patients remain free from cancer events and will also monitor overall survival and treatment response rates.

Investigational drugs: Pembrolizumab is the main investigational drug being studied. It is given as an intravenous infusion directly into the bloodstream. This medication blocks a protein called PD-1 on immune cells, which helps the immune system better detect and destroy cancer cells. The study also involves neoadjuvant chemotherapy, which means chemotherapy given before surgery to help shrink the tumor and make it easier to remove.

Inclusion criteria: To participate in this trial, patients must meet several requirements:

• Have a confirmed diagnosis of urothelial carcinoma or muscle-invasive bladder cancer, with at least 50% of the tumor made up of urothelial cells
• Have cancer that has not spread to distant parts of the body, as confirmed by CT or MRI scans of the chest, abdomen, and pelvis
• Be suitable candidates for surgery to remove the bladder and nearby lymph nodes (radical cystectomy and pelvic lymph node dissection)
• Have an ECOG Performance Status of 0 or 1, meaning they can perform daily activities with little to no restriction
• Have adequate organ function, particularly of the liver and kidneys
• Agree to use appropriate birth control methods as outlined in the study guidelines

Exclusion criteria: Patients cannot participate if they:

• Do not have muscle-invasive bladder cancer that is eligible for cisplatin treatment
• Fall outside the specified age range for the study
• Do not meet the clinical trial group requirements
• Are considered part of a vulnerable population, meaning individuals who might be at higher risk of harm or exploitation during the study

What to expect: Participants will be randomly assigned to receive either pembrolizumab with chemotherapy or a placebo with chemotherapy. The treatment is administered through intravenous infusions at scheduled intervals. After completing the initial treatment phase, patients will undergo surgery to remove the bladder and nearby lymph nodes. Following surgery, participants will continue to be monitored through regular check-ups and tests. The study is expected to continue until June 2025.

Summary

Currently, there is one ongoing clinical trial for patients with Stage II bladder cancer, specifically focusing on muscle-invasive bladder cancer. This trial is widely accessible across Europe, being conducted in eleven countries including Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain, Sweden, and Espagne. The study focuses on combining pembrolizumab, an immunotherapy drug, with standard chemotherapy drugs cisplatin and gemcitabine, and represents an important investigation into whether immune checkpoint inhibitors can improve outcomes when added to traditional treatment approaches for this type of cancer.