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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 175
- 主要终点
- Cohort A: Event-free Survival (EFS)
研究概览
简要总结
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.
详细描述
As of Amendment 03 (effective 01/05/2026), outcome measures associated with the Intismeran autogene Monotherapy Arm (Cohort B) are no longer considered primary or secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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)
排除标准
- •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)
- •Has current active tuberculosis
- •Has a known history of HIV infection
- •- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
研究组 & 干预措施
BCG
Participants in Cohort A receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75
干预措施: BCG (Biological)
Intismeran autogene
Participants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.
干预措施: Intismeran autogene (Biological)
Intismeran autogene + BCG
Participants in Cohort A receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.
干预措施: Intismeran autogene (Biological)
Intismeran autogene + BCG
Participants in Cohort A receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.
干预措施: BCG (Biological)
结局指标
主要结局
Cohort A: Event-free Survival (EFS)
时间窗: Up to approximately 5 years
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.
次要结局
- Cohort A: Complete Response Rate (CRR)(Up to approximately 5 years)
- Cohort A: Duration of Response (DOR)(Up to approximately 5 years)
- Cohort A: Time to Cystectomy(Up to approximately 5 years)
- 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)
- Cohort A: 12 Month Overall Survival Rate (OSR)(Up to approximately 12 months)
- Cohort A: 24 Month Overall Survival Rate (OSR)(Up to approximately 24 months)
- Cohort A: Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 21 months)
- Cohort A: Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 18 months)