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A Clinical Study of V940 Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer.
Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer.
Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving V940 (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery.
V940 (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells. The goals of this study are to learn if people who receive V940 and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of V940, pembrolizumab, and EV, and if people tolerate them.
Study details:
Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned to start in approximately February of 2025.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-28
Primary completion: 2026-10-08
Study completion finish: 2031-04-08
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06305767
Intervention or treatment
BIOLOGICAL: Pembrolizumab
BIOLOGICAL: V940
OTHER: Placebo
BIOLOGICAL: Enfortumab Vedotin
PROCEDURE: Surgery (RC plus PLND)
Conditions
- • Bladder Cancer
Find a site
Closest Location:
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)
Research sites nearby
Select from list below to view details:
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)
Macquarie University, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 1802)
Westmead, New South Wales, Australia
One Clinical Research ( Site 1807)
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Adjuvant Cohort: Pembrolizumab + V940
| BIOLOGICAL: Pembrolizumab
|
ACTIVE_COMPARATOR: Adjuvant Cohort: Pembrolizumab + Placebo
| BIOLOGICAL: Pembrolizumab
|
EXPERIMENTAL: Perioperative Cohort: Pembrolizumab + V940 + Enfortumab Vedotin (EV) and Surgery
| BIOLOGICAL: Pembrolizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Adjuvant Cohort: Disease Free Survival (DFS) | DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease or any high-grade non-muscle invasive disease in the urothelial tract (upper tract or lower tract) on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for the Adjuvant Cohort. | Up to approximately 28 months |
Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience AEs will be reported for the Perioperative Cohort. | Up to approximately 19 months |
Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be reported for the Perioperative Cohort. | Up to approximately 16 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Adjuvant Cohort: Overall Survival (OS) | Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for the Adjuvant Cohort. | Up to approximately 28 months |
Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS) | DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for the Adjuvant Cohort. | Up to approximately 28 months |
Adjuvant Cohort: Number of Participants Who Experience an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for the Adjuvant Cohort. | Up to approximately 16 months |
Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be presented for the Adjuvant Cohort. | Up to approximately 13 months |
Perioperative Cohort: Pathologic Complete Response (pCR) Rate | pCR is defined as the absence of viable tumor (pT0N0) in examined tissue from RC plus PLND as assessed by the investigator. pCR rate will be reported as the percentage of participants in the Perioperative Cohort having pCR. | Up to approximately 18 weeks |
Perioperative Cohort: Pathologic Downstaging (pDS) Rate | pDS is defined as participants with \<pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC plus PLND as assessed by the investigator. pDS rate will be reported as the percentage of participants in the Perioperative Cohort having pDS. | Up to approximately 18 weeks |
Frequently Asked Questions
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