V940 + BCG for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to treating high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that hasn't invaded the muscle but may worsen or return. Researchers are testing a treatment called intismeran autogene (also known as V940), which aims to enhance the immune system's ability to target cancer. They compare it with the standard treatment, BCG, to determine if the combination is more effective. This trial may suit individuals who have recently undergone surgery to remove bladder tumors and have either never tried BCG or haven't used it in the past two years. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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, if you are on systemic anticancer therapy or chronic systemic steroid therapy, you may need to stop these before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intismeran autogene, when combined with the standard treatment BCG, is a promising option for bladder cancer. Other research has found this treatment to be well-tolerated by individuals with various solid tumors.
Although complete safety data for intismeran autogene in bladder cancer is not yet available, studies in other cancers suggest it is reasonably safe. Importantly, these studies typically check for serious side effects and have not identified major safety issues so far.
This trial is in Phase 2, indicating that the treatment has already passed initial safety tests. This phase focuses more on evaluating the treatment's effectiveness while still monitoring safety. The treatment is considered safe enough to reach this stage, but ongoing monitoring remains essential to confirm this.12345Why are researchers excited about this trial's treatments?
Researchers are excited about intismeran autogene because it offers a new approach for bladder cancer treatment. Unlike the standard of care, which typically involves Bacillus Calmette-Guerin (BCG) immunotherapy, intismeran autogene is an experimental vaccine given via intramuscular injection. This vaccine is designed to stimulate the immune system differently, potentially enhancing its ability to target and destroy cancer cells. When combined with BCG in one of the trial arms, it may offer a synergistic effect, boosting overall treatment efficacy. The novel mechanism and delivery method of intismeran autogene provide a promising new avenue for improving outcomes in bladder cancer patients.
What evidence suggests that this trial's treatments could be effective for high-risk non-muscle invasive bladder cancer?
Research has shown that intismeran autogene is a promising treatment for high-risk non-muscle invasive bladder cancer (HR NMIBC). This personalized therapy helps the immune system identify and combat cancer cells. In this trial, some participants will receive intismeran autogene alone, while others will receive it alongside the standard treatment, Bacillus Calmette-Guerin (BCG). Early results suggest that combining intismeran autogene with BCG could lead to better outcomes, potentially allowing patients to live longer without cancer progression or recurrence compared to BCG alone. Additionally, the treatment has shown promise in other types of bladder cancer, indicating broad effectiveness. Overall, early trials suggest that intismeran autogene, especially when combined with BCG, could surpass the effectiveness of current treatments.12567
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for individuals with high-risk non-muscle invasive bladder cancer (HR NMIBC), including carcinoma in situ (CIS). Participants must have had a recent tumor removal surgery and either never received BCG therapy or not within the last two years. People living with well-controlled HIV on treatment can join, but those who've had certain BCG treatments or refuse specific therapies cannot participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either BCG monotherapy or intismeran autogene in combination with BCG. BCG is administered once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75. Intismeran autogene is administered every 3 weeks for 9 doses.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments for event-free survival and recurrence-free survival.
What Are the Treatments Tested in This Trial?
Interventions
- V940
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead 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
ModernaTX, Inc.
Industry Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris