Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Participants With Resected Solid Tumors and in Combination With Pembrolizumab in Participants With Unresectable Solid Tumors

计划状态

招聘

阶段

第 1 阶段

允许先接受免疫治疗

没有

CRC 指导的试验

没有

药物

mRNA-4157, Pembrolizumab, Keytruda

标签

MSS/ MMRp

评论

mRNA-4157 [Personalized cancer vaccine] alone or in combination with Keytruda. In Part C, admits MSS-CRC patients who not have received prior anti‑PD‑1/PD-L1 therapy, AND have measurable disease at study entry.

地点 位置状态
美国
University of Arizona
Tucson, Arizona 85721
招聘
Angeles Clinic and Research Institute
加利福尼亚州洛杉矶 90025
招聘
The George Washington Cancer Center
Washington, District of Columbia 20037
招聘
Orlando Health Cancer Institute
佛罗里达州奥兰多 32806
招聘
Florida Cancer Specialists
佛罗里达州萨拉索塔 34232
招聘
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612-9416
招聘
麻省总医院
马萨诸塞州波士顿 02114
招聘
Hackensack University Medical Center, John Theurer Cancer Center
新泽西州哈肯萨克 07601
招聘
NYU Langone Medical Center
纽约州纽约市 10016
招聘
杜克癌症研究所
北卡罗来纳州达勒姆 27710
招聘
The Cleveland Clinic Foundation
Cleveland, Ohio 44195-0001
招聘
普罗维登斯波特兰医疗中心
Portland, Oregon 97213-2933
撤回
UPMC 希尔曼癌症中心
Pittsburgh, Pennsylvania 15219
招聘
SCRI, Oncology Partners
田纳西州纳什维尔 37203
招聘
澳大利亚
St Vincents Hospital Sydney
Darlinghurst, New South Wales
招聘
Scientia Clinical Research Ltd
Randwick, New South Wales
招聘
Westmead Hospital-Cnr Hawkesbury and Darcy Road
Westmead, New South Wales
招聘
伊丽莎白医院
Woodville South, South Australia
招聘
PASO Medical
Frankston, Victoria
招聘
One Clinical Research Perth
Perth, Western Australia
招聘
日本
National Cancer Center East
Chiba
招聘
金台大学医院
Osaka
招聘
国家癌症中心医院
Tokyo
招聘
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo
招聘
英国
NHS Tayside
Dundee, Scotland
招聘
帝国学院医疗保健 NHS 信托公司
伦敦
招聘
Royal Mardsen London
伦敦
招聘
University College of London
伦敦
招聘
克里斯蒂国民医疗服务基金会信托基金
Manchester
招聘
Oxford University Hospitals NHS Foundation Trust
Oxford
招聘
Royal Mardsen Sutton
Sutton
招聘

联系方式

纳入标准

纳入标准

* Parts A, A2, and D: Participants must be clinically disease-free at study entry (that is, participants in the adjuvant setting).
* Part B: Participants must have one of the histologically- or cytologically-confirmed unresectable (locally advanced or metastatic) protocol-specified solid malignancies, have measurable disease at study entry defined by RECIST 1.1., and be considered suitable for treatment with pembrolizumab; in this study pembrolizumab will be considered an investigational study drug.
* Part C: Participants must have one of the histologically- or cytologically confirmed unresectable (locally advanced or metastatic) protocol-specified solid malignancies, must not have received prior anti-programmed cell death protein 1 (PD-1)/programmed death -ligand 1 (PD-L1) therapy, and must have measurable disease at study entry defined by RECIST 1.1.
* Part A2: Participants with histologically confirmed PDAC who have undergone complete macroscopic resection(that is, R0 - no cancer cells within 1 mm of all resection margins or R1 - cancer cells present within 1 mm of one or more resection margins) who had no evidence of metastatic disease with adequate recovery from surgery to receive adjuvant therapy.
* Parts E1 and E2: Participants with untreated histologically/cytologically confirmed Stage II-IIIB NSCLC (per AJCC version 8) that is considered resectable of non-squamous (adenocarcinoma only) or squamous cell carcinoma histology, absence of major associated pathologies that increase the surgery risk to an unacceptable level, must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
* Part E3: Participants with untreated, locally advanced surgically resectable, histologically/cytologically confirmed, gastric/GEJ adenocarcinoma, as defined by a primary lesion that is T3 or greater or with the presence of any positive clinical nodes (N+) and without evidence of metastatic disease, measurable disease according to RECIST version 1.1, absence of major associated pathologies that increase the surgery risk to an unacceptable level, must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
* Part D: Participants with completely resected Stage II, III or IV cutaneous melanoma.
* Parts A, A2, and D: Participants must have a formalin-fixed paraffin embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next generation sequencing (NGS) required for this study.
* Parts B and C: Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry.
* Participants must have resolution of toxic effect(s) (as specified in the protocol) from prior therapy to Grade 1 or less.
* Participant is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential), or for a specified time after the last dose of SoC chemotherapy per SoC product labeling, whichever is later.
* Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS.

排除标准

排除标准:

* Treatment with any of the following:

1. Any investigational agents, anti-cancer monoclonal antibody, anti-cancer therapeutic vaccine, immunostimulant (for example, IL-2), or study drugs from a previous clinical study within 4 weeks of the first dose of mRNA-4157 or pembrolizumab (note only a 2 week wash out is required from prior pembrolizumab treatment)
2. Any chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of the first dose of mRNA-4157 or pembrolizumab
3. Live-virus vaccination within 30 days of the first dose of mRNA-4157 or pembrolizumab. Seasonal flu vaccines that do not contain live virus are permitted.
4. Any systemic steroid therapy or other form of immunosuppressive therapy within 7 days of the first dose of mRNA-4157 or pembrolizumab
5. Transfusion of blood products (including platelets or red blood cells [RBCs]) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte/macrophage colony stimulating factor [GM-CSF], or recombinant erythropoietin) within 1 week of the NGS blood sample during screening, and 4 weeks of the first dose of mRNA-4157 or pembrolizumab
* A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Previously identified hypersensitivity to components of the formulations used in this study
* Known additional malignancy that is progressing or requires active treatment, exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone curative therapy, or in situ cervical cancer.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

NCT ID

NCT03313778

添加审判日期

2017-10-18

更新日期

2025-03-25