A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Has CIS +/-papillary non-muscle invasive UC of the bladder
Is ineligible for, or refusing, any IVESIC therapy
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intismeran autogene
Biological/VaccineIM injection
BCG
Biological/VaccineIntravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.
Treatment groups
308 Participants
are divided into 3 treatment groupsGroup A: Intismeran autogene + BCGExperimental treatment 2 interventions
Group B: BCGActive comparator 1 intervention
Group C: Intismeran autogeneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cohort A: Event-free Survival (EFS)
EFS is defined as the time from randomization to any of the following events, as determined by blinded independent central review (BICR): High-grade (HG) non-invasive papillary carcinoma (Ta) or carcinoma in situ (CIS) in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of urothelial carcinoma (UC); High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant metastasis of UC including non-regional lymph nodes (stage M1)\]; Or death due to any cause. The EFS for BCG-treated participants will be presented.
Time frame
Up to approximately 5 yearsSecondary outcomes
1
Cohort A: 12-Month Event-free Survival (EFS)
EFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or CIS in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of UC; High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)\]; Or death due to any cause. The EFS at 12 months for BCG-treated participants will be presented.
Time frame
Up to approximately 12 months2
Cohort A: 24-Month Event-free Survival (EFS)
EFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or CIS in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of UC; High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)\]; Or death due to any cause. The EFS at 24 months for BCG-treated participants will be presented.
Time frame
Up to approximately 24 months3
Cohort A: Recurrence-free Survival (RFS)
RFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or CIS in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of UC; High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)\]; Death due to any cause; or any other UC recurrence including low-grade (LG) Ta at any timepoint as well as HG Ta or CIS in the bladder before the 24-week assessment. The RFS will be presented.
Time frame
Up to approximately 5 years4
Cohort A: Disease-specific Survival (DSS)
DSS is defined as the time from randomization to death due to bladder cancer. The DSS will be presented.
Time frame
Up to approximately 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Merck Sharp & Dohme LLC
Lead sponsor
ModernaTX, Inc.
Collaborator
Source ClinicalTrials.gov