2025-520902-37-00招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 20
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
-
To compare V940 versus placebo when combined with pembrolizumab and platinum chemotherapy with respect to progression-free survival (PFS) (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review (BICR)
-
To compare V940 versus placebo when combined with pembrolizumab and platinum chemotherapy with respect to overall survival (OS)
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
- •The participant must have a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, American Joint Committee on Cancer (AJCC) Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
- •Has a life expectancy of at least 3 months
- •Has adequate organ function
- •Is of any sex/gender, from 18 years at the time of providing the informed consent.
- •Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
- •Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
- •Have AEs due to previous anticancer therapies must have recovered to ≤Grade
- •Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
排除标准
- •Is a HIV-infected participant with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
- •Has 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 active infection requiring systemic therapy
- •Has a history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or have ongoing surgical complications
- •Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
- •Has received prior systemic anticancer therapy for their metastatic NSCLC
- •Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
- •Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- •Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- •Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
研究组 & 干预措施
DOCETAXEL
Test
干预措施: DOCETAXEL (Drug)
CARBOPLATIN
Test
干预措施: CARBOPLATIN (Drug)
PACLITAXEL
Test
干预措施: PACLITAXEL (Drug)
mRNA-4157
Test
干预措施: mRNA-4157 (Drug)
KEYTRUDA 25 mg/mL concentrate for solution for infusion.
Test
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion. (Drug)
PACLITAXEL ALBUMIN-BOUND
Test
干预措施: PACLITAXEL ALBUMIN-BOUND (Drug)
Placebo to V940
Placebo
干预措施: Placebo to V940 (Drug)
结局指标
主要结局
Progression-free survival (PFS)
Progression-free survival (PFS)
Overall survival (OS)
Overall survival (OS)
次要结局
- Duration of response (DOR)
- Objective response rate (ORR)
- Number of Participants With ≥1 Adverse Event (AE)
- Number of Participants Discontinuing From Study Therapy Due to an AE
研究者
Niyati Bhagwati
Scientific
Merck Sharp & Dohme LLC
研究点 (20)
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