NCT06307431进行中（未招募）2 期
A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma (INTerpath-004).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
- 试验地点
- 125
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
- •Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
- •Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
- •High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
- •M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous)
- •Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
- •Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
排除标准
- •Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization.
- •Has residual thrombus post nephrectomy in the vena renalis or vena cava.
- •Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
- •Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- •Received prior treatment with a cancer vaccine.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has a history of brain or bone metastatic lesions.
- •Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has an active infection requiring systemic therapy
- •History of allogeneic tissue/solid organ transplant
- •Has not adequately recovered from major surgery or has ongoing surgical complications
研究组 & 干预措施
Intismeran autogene + Pembrolizumab
Experimental
Participants will receive intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks (Q3W) for up to 9 doses plus Pembrolizumab 400 mg via an intravenous (IV) infusion every 6 weeks (Q6W) for 9 cycles (up to ~54 weeks). Each cycle is 6 weeks.
干预措施: Intismeran autogene (Biological)
Intismeran autogene + Pembrolizumab
Experimental
Participants will receive intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks (Q3W) for up to 9 doses plus Pembrolizumab 400 mg via an intravenous (IV) infusion every 6 weeks (Q6W) for 9 cycles (up to ~54 weeks). Each cycle is 6 weeks.
干预措施: Pembrolizumab (Biological)
Placebo + Pembrolizumab
Active Comparator
Participants will receive placebo as an IM injection Q3W for up to 9 doses plus Pembrolizumab 400 mg via an IV infusion Q6W for 9 cycles (up to ~54 weeks). Each cycle is 6 weeks.
干预措施: Placebo (Biological)
Placebo + Pembrolizumab
Active Comparator
Participants will receive placebo as an IM injection Q3W for up to 9 doses plus Pembrolizumab 400 mg via an IV infusion Q6W for 9 cycles (up to ~54 weeks). Each cycle is 6 weeks.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: up to ~43 months
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first.
次要结局
- Percentage of Participants Who Experience an Adverse Event (AE)(up to ~15 months)
- Overall Survival (OS)(up to ~96 months)
- Percentage of Participants Who Discontinue Study Treatment Due to an AE(up to ~12 months)
- Distant Metastasis-free survival (DMFS)(up to ~ 43 months)
研究者
研究点 (125)
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相关资讯
Personalized Cancer Vaccine Shows Promising Results in Advanced Kidney Cancer Trial- A groundbreaking Phase 1 trial at Yale Cancer Center demonstrated successful anti-cancer immune responses in all nine patients with advanced kidney cancer using personalized therapeutic vaccines.
- The vaccine, designed to target specific tumor mutations, generated strong T-cell responses within three weeks of treatment and maintained effectiveness for approximately three years post-treatment.
- Patients experienced minimal side effects, primarily mild flu-like symptoms, suggesting a favorable safety profile for this innovative approach to treating advanced clear cell renal cell carcinoma.last yearMerck and Moderna Advance mRNA-Based Cancer Therapy in Phase 3 Lung Cancer Trial- Merck and Moderna have initiated a Phase 3 trial (INTerpath-009) to evaluate V940 (mRNA-4157) combined with KEYTRUDA in resected Stage II-IIIB NSCLC patients.
- The trial focuses on patients who did not achieve a pathological complete response (pCR) after neoadjuvant KEYTRUDA plus platinum-based chemotherapy.
- mRNA-4157 is an individualized neoantigen therapy designed to stimulate an antitumor immune response based on a patient's unique tumor mutation signature.
- This collaboration expands the INTerpath clinical trial program, aiming to improve outcomes for early-stage lung cancer patients with this novel mRNA modality.last year