Pembrolizumab for Bladder Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are on chronic systemic steroid therapy exceeding 10 mg daily of prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug. It's best to discuss your current medications with the trial team.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What data supports the idea that Pembrolizumab for Bladder Cancer is an effective drug?
The available research shows that Pembrolizumab is effective for treating bladder cancer in several ways. It was approved by the FDA for patients with a specific type of bladder cancer that doesn't respond to other treatments and who can't or don't want to have surgery. In studies, Pembrolizumab was used before surgery for muscle-invasive bladder cancer and showed positive results. It was also compared to traditional chemotherapy for advanced bladder cancer and was found to help patients live longer. This makes it a strong option for those who can't use standard chemotherapy.12345
What data supports the effectiveness of the drug pembrolizumab for bladder cancer?
Pembrolizumab has been approved by the FDA for certain types of bladder cancer, showing effectiveness in patients who cannot undergo surgery or have not responded to other treatments. It has also shown benefits in improving survival for advanced bladder cancer patients compared to traditional chemotherapy.12345
What safety data is available for pembrolizumab in bladder cancer treatment?
Pembrolizumab, also known as Keytruda or MK-3475, has been evaluated for safety in several studies. It is approved by the FDA for BCG-unresponsive, high-risk, non-muscle invasive bladder cancer. Safety concerns include immune-related adverse events, as reported in a case of pembrolizumab-induced myasthenia gravis with myositis and presumable myocarditis in a bladder cancer patient. The KEYNOTE-012 study assessed its safety in locally advanced or metastatic urothelial cancer, and a real-life study evaluated its safety in metastatic urothelial carcinoma patients. Overall, pembrolizumab has shown clinical benefits but also potential safety risks that need to be monitored.26789
Is pembrolizumab safe for humans?
Pembrolizumab, also known as Keytruda, has been studied for safety in various conditions, including bladder cancer. Some patients have experienced immune-related side effects, such as myasthenia gravis (a condition causing muscle weakness) and myocarditis (inflammation of the heart). However, it has been approved by the FDA for certain types of bladder cancer, indicating that its benefits may outweigh the risks for some patients.26789
Is the drug Pembrolizumab a promising treatment for bladder cancer?
Yes, Pembrolizumab is a promising drug for bladder cancer. It has been approved by the FDA for certain types of bladder cancer that don't respond to other treatments. It has shown to improve survival in advanced bladder cancer and is effective for patients who can't use other common treatments.2381011
What makes the drug pembrolizumab unique for treating bladder cancer?
Pembrolizumab is unique because it is an immune checkpoint inhibitor that targets PD-1, helping the immune system attack cancer cells. It is approved for patients with bladder cancer who cannot undergo surgery or have not responded to other treatments, offering a new option for those with limited choices.2381011
What is the purpose of this trial?
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol.Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Research Team
Matthew Galsky, M.D.
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Adults with muscle-invasive urothelial bladder cancer (cT2-T3N0M0) who haven't had systemic chemotherapy or radiation for it, can decline or are ineligible for cisplatin-based chemo due to certain health conditions. They must have adequate organ function and agree to use contraception. Excluded if pregnant, breastfeeding, recently vaccinated with live vaccines, have active infections or other health issues that could affect the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two cycles of pembrolizumab, followed by restaging MRI, CT, cystoscopy, and biopsies
Maintenance or Adjuvant Treatment
Participants achieving a clinical complete response receive maintenance pembrolizumab; others receive standard local therapy followed by adjuvant pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vaibhav Patel
Lead Sponsor
Matthew Galsky
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University