CTIS2023-505712-37-00招募中1 期
A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) (INTerpath-007). - V940-007
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 607
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Has a histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) (cSCC that is amenable to achieve complete oncologic resection (R0 or R1) and is not expected to result in permanent significant functional loss or severe disfigurement) as the primary site of malignancy., Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization., Has adequate organ function., Hepatitis B surface antigen (HBsAg) positive participants are considered eligible if 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 at screening., Human Immunodeficiency Virus (HIV)-infected participants has well controlled HIV on antiretroviral therapy (ART)., Has locally advanced (LA) Stage II-IV (M0) cSCC without distant metastases., cSCC is amenable to surgery (resectable) with curative intent., Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available that is suitable for the Next-generation Sequencing (NGS) required for this study. The sample should meet the protocol defined criteria., Is an individual of any sex/gender and at least 18 years of age., For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving adjuvant radiation therapy (RT), and for =3 months after the last dose of study intervention., Is female and not pregnant/breastfeeding and at least one of the following applies during the study : is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) at least during use of V940: 15 days, Pembrolizumab: 120 days, Adjuvant RT, if performed: 90 days after last exposure or is a WOCBP who is abstinent from heterosexual intercourse., Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology., Has a life expectancy of >3 months per investigator assessment.
排除标准
- •Has any other histologic type of skin cancer other than invasive cSCC as well as mixed histology., Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration., Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy any other form of immunosuppressive therapy within 7 days prior the first dose of study medication., Has known additional malignancy that is progressing or has required active treatment within the past 2 years., Has history of chronic lymphocytic leukemia (CLL)., Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis., Has active autoimmune disease that has required systemic treatment in the past 2 years., Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has active infection requiring systemic therapy., HIV-infected participant has history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Has concurrent active Hepatitis B and Hepatitis C virus infection., Has distant metastatic disease (M1), visceral and/or distant nodal., Has myocardial infarction within 6 months of randomization., Has history of allogeneic tissue/solid organ transplant., Participants who have not adequately recovered from major surgery or have ongoing surgical complications., Has received prior therapy with an anti-programmed cell death receptor 1 (anti-PD-1), anti-programmed cell death receptor ligand 1 (anti-PD-L1), or anti-programmed cell death receptor ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte associated protein 4 (CTLA-4), OX-40, CD137)., Has received prior systemic anticancer therapy including investigational agents for cSCC before randomization., Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids., 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 transfusion of blood products., Has received prior treatment with another cancer vaccine., Has received prior radiotherapy to the index lesion (in-field lesion).
研究者
相似试验
进行中（未招募）
1 期
Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patientsCoronavirus infectionEUCTR2020-001270-29-CZsanofi-aventis recherche & développement350
进行中（未招募）
1 期
Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patientsCoronavirus infectionEUCTR2020-001270-29-GBsanofi-aventis recherche & développement350
进行中（未招募）
1 期
Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patientsCoronavirus infectionMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-001270-29-DKsanofi-aventis recherche & développement350
进行中（未招募）
1 期
Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patientsMedDRA version: 20.1Level: PTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestationsCoronavirus infectionEUCTR2020-001270-29-FRsanofi-aventis recherche & développement350
进行中（未招募）
1 期
Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patientsCoronavirus infectionEUCTR2020-001270-29-DEsanofi-aventis recherche & développement350