A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
New bladder cancer treatment tested in combination with standard therapy
Plain English Summary
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ. This study tests a new drug called V940 combined with BCG, a standard bladder cancer treatment. It is for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC), including a type called carcinoma in situ (CIS). Participants will receive either the new drug plus BCG or BCG alone, and will be closely monitored. Alternatives include standard BCG treatment, surgery to remove tumors, and other therapies depending on the cancer's stage. The trial aims to enroll 308 participants.
Official Summary
Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with high-risk bladder cancer that has not spread to the muscle layer, including CIS. Patients who have not received BCG recently or who recurred after a long period without BCG. Patients with CIS who cannot receive or refuse standard IVESIC therapy. Individuals with certain other cancers, recent heart attacks, or active autoimmune diseases may not be eligible. This trial is studying Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if the new drug combination helps patients live longer without their cancer growing, spreading, or returning, compared to BCG alone. The specific primary outcome measures are: Cohort A: Event-free Survival (EFS) (Up to approximately 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a need for more effective treatments for high-risk bladder cancer, where standard BCG therapy may not always work. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ, where improved treatment options are needed.
Investor Insight
This trial explores a novel immunotherapy approach for a significant market of bladder cancer patients, with potential to improve outcomes if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of V940 and BCG, and what participation involves. Understand that you will be randomly assigned to receive either the new drug plus BCG or BCG alone. Day-to-day involvement will include regular clinic visits for treatment, monitoring, and tests. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 308 participants
Interventions
- BIOLOGICAL: Intismeran autogene — IM injection
- BIOLOGICAL: BCG — Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Primary Outcomes
- Cohort A: Event-free Survival (EFS) (Up to approximately 5 years)
Secondary Outcomes
- Cohort A: 12-Month Event-free Survival (EFS) (Up to approximately 12 months)
- Cohort A: 24-Month Event-free Survival (EFS) (Up to approximately 24 months)
- Cohort A: Recurrence-free Survival (RFS) (Up to approximately 5 years)
- Cohort A: Disease-specific Survival (DSS) (Up to approximately 5 years)
- Cohort A: Overall Survival (OS) (Up to approximately 5 years)
Full Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology Cohort A: * Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder * Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG Cohort B: * Has CIS +/-papillary non-muscle invasive UC of the bladder * Is ineligible for, or refusing, any IVESIC therapy * Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG * Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC * Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions * Has a known additional malignancy that is progressing or has required active treatment within the last 3 years * Has had a myocardial infarction within 6 months of randomization/allocation * Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation * Has received prior treatment with a cancer vaccine * Has immunodeficiency or is receiving chronic systemic steroid therapy * Has active autoimmune disease that has required systemic treatment in the last 2 years * Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU) Cohort A: * Has current active tuberculosis * Has a known history of HIV infection Cohort B: \- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Trial Locations
- Michael G Oefelein Clinical Trials ( Site 0138), Bakersfield, California, United States
- Genesis Research, LLC ( Site 0141), Los Alamitos, California, United States
- USC Norris Comprehensive Cancer Center ( Site 0123), Los Angeles, California, United States
- Genesis Healthcare-Torrance ( Site 0140), Torrance, California, United States
- Genesis Research LLC ( Site 0118), Torrance, California, United States
- Urology Associates ( Site 0144), Littleton, Colorado, United States
- Urological Research Network ( Site 0133), Hialeah, Florida, United States
- Associated Urological Specialists - Chicago Ridge ( Site 0139), Chicago Ridge, Illinois, United States
- Southern Urology, LLC ( Site 0145), Lafayette, Louisiana, United States
- University of Missouri Health Care ( Site 0126), Columbia, Missouri, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06833073?
NCT06833073 is a Phase 2 INTERVENTIONAL study titled "A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 308 participants.
What conditions does NCT06833073 study?
This trial investigates treatments for Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ. The primary condition under study is Urinary Bladder Neoplasms.
What treatments are being tested in NCT06833073?
The interventions being studied include: Intismeran autogene (BIOLOGICAL), BCG (BIOLOGICAL). IM injection
What does Phase 2 mean for NCT06833073?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06833073?
This trial is currently "Recruiting." It started on 2025-03-11. The estimated completion date is 2031-09-03.
Who is sponsoring NCT06833073?
NCT06833073 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06833073?
The trial aims to enroll 308 participants. The trial is currently recruiting and accepting new participants.
How is NCT06833073 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06833073?
The primary outcome measures are: Cohort A: Event-free Survival (EFS) (Up to approximately 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06833073 being conducted?
This trial is being conducted at 20 sites, including Bakersfield, California; Los Alamitos, California; Los Angeles, California; Torrance, California and 16 more sites (United States).
Where can I find official information about NCT06833073?
The official record for NCT06833073 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06833073. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06833073 testing in simple terms?
This study tests a new drug called V940 combined with BCG, a standard bladder cancer treatment. It is for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC), including a type called carcinoma in situ (CIS).
Why is this trial significant?
This trial addresses a need for more effective treatments for high-risk bladder cancer, where standard BCG therapy may not always work.
What are the potential risks of participating in NCT06833073?
Potential side effects of V940 and BCG can include flu-like symptoms, fatigue, and bladder irritation. As with any cancer treatment, there is a risk that the cancer may not respond or may return. Specific risks related to BCG include bladder inflammation and infection. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06833073?
Ask your doctor about the potential benefits and risks of V940 and BCG, and what participation involves. Understand that you will be randomly assigned to receive either the new drug plus BCG or BCG alone. Day-to-day involvement will include regular clinic visits for treatment, monitoring, and tests. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06833073 signal from an investment perspective?
This trial explores a novel immunotherapy approach for a significant market of bladder cancer patients, with potential to improve outcomes if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive either the new drug plus BCG or BCG alone, and will be closely monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.