2023-503652-27-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (INTerpath-001)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 596
- 试验地点
- 59
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to RFS.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Has resected cutaneous melanoma with histological confirmed stage IIB to IV.
- •HCV infected participants are eligible if HCV viral load is undetectable at screening.
- •HIV-infected participants must have well controlled HIV on ART.
- •Has not received any prior systemic therapy for their melanoma beyond surgical resection.
- •Complete resection that rendered the participant disease-free within 13 weeks prior to the first dose of pembrolizumab.
- •Has a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing.
- •Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases.
- •All suspicious lesions amenable to biopsy should be confirmed negative for malignancy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- •Adequate organ function, specimens must be collected within 7 days before the start of study intervention.
- •HBsAg positive participants have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
排除标准
- •Has ocular or mucosal melanoma.
- •Active autoimmune disease.
- •Pneumonitis/interstitial lung disease or a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids.
- •Active infection requiring treatment.
- •HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- •Known active hepatitis B or C.
- •Has history of allogeneic tissue/solid organ transplant.
- •Has unresectable in-transit metastases.
- •Clinically significant heart failure.
- •Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample.
- •Has received prior anticancer systemic or immunotherapy or another cancer vaccine or radiotherapy before starting of study intervention.
- •Live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- •Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •History of CNS metastases and/or carcinomatous meningitis.
结局指标
主要结局
Recurrence-Free Survival (RFS)
Recurrence-Free Survival (RFS)
次要结局
- Distant Metastasis Free Survival (DMFS)
- Overall Survival
- Number of Participants Experiencing Adverse Events (AEs)
- Number of Participants Discontinuing Study Treatment Due to AEs
- Change in Score from Baseline Evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30)
- Change in Score from Baseline Evaluated by: - Physical Functioning Score (QLQ-C30 Items 1 to 5)
- Change in Score from Baseline Evaluated by: - Role Functioning Score (QLQ-C30 Items 6 and 7)
研究者
Julius Paul Duic
Scientific
Merck Sharp & Dohme LLC
研究点 (59)
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