Pemetrexed + Avelumab for Bladder Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) around the time of pemetrexed administration. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Pemetrexed and Avelumab for bladder cancer?
Avelumab has been shown to prolong overall survival in advanced urothelial carcinoma when used as a maintenance treatment after initial chemotherapy. Pemetrexed has demonstrated a favorable response rate of about 30% with minimal toxicity in advanced urothelial carcinoma, suggesting potential effectiveness when combined with other treatments.12345
Is the combination of Pemetrexed and Avelumab safe for humans?
Pemetrexed has shown minimal toxicity when used alone for advanced urothelial cancer, and it has been used safely in combination with other drugs like cisplatin. Avelumab, also known as Bavencio, is generally considered safe as it is approved for use in other conditions, but specific safety data for the combination of Pemetrexed and Avelumab in bladder cancer is not provided in the available research.36789
How is the drug combination of Pemetrexed and Avelumab unique for treating bladder cancer?
The combination of Pemetrexed and Avelumab is unique because it pairs a chemotherapy drug (Pemetrexed) with an immune checkpoint inhibitor (Avelumab), which may enhance the body's immune response against bladder cancer cells, potentially offering a novel approach compared to traditional chemotherapy alone.1361011
What is the purpose of this trial?
This phase II trial studies how well pemetrexed and avelumab work in treating patients with MTAP-deficient urothelial cancer that has spread to other places in the body. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pemetrexed and avelumab may work better in treating patients with MTAP-deficient urothelial cancer.
Research Team
Amishi Y. Shah
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with MTAP-deficient metastatic urothelial cancer, who can stop NSAIDs as required, have measurable disease, normal organ function tests, and no severe autoimmune diseases. Participants must not be pregnant or breastfeeding and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pemetrexed IV on day 1 and avelumab IV starting cycle 2, with cycles repeating every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Avelumab
- Pemetrexed
Avelumab is already approved in European Union, United States, Japan for the following indications:
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
- Merkel cell carcinoma
- Renal cell carcinoma
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator