Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group. - Immunotherapy with anti-PD in stage III melanoma

Merck Sharp & Dohme (MSD)0 个研究点目标入组 108 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 108

研究概览入排标准研究者记录与标识符相似试验

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 99（—）

入选标准

•Please see protocol summary section Diagnosis and main criteria for inclusion,
•for full description
•- At least 18 years of age.
•- written informed consent must be given
•- Complete resection of Stage III melanoma (AJCC R0) with histologically
•confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC,
•2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC. No past or
•current in-transit metastases or satellitosis..
•- Melanoma with unknown origin of the primary is eligible
•- Mandatory to ship tumor sample for evaluation of PD-L1 expression.
•- The maximum duration from surgery to first study drug treatment is 13 weeks.
•Treatment should start only after complete wound healing from the surgery.
•Note: If there is a delay of 1-7 days exceeding 13 weeks due to extreme
•unforeseen circumstances, the eligibility should be discussed with the medical
•- Disease status for the post-surgery baseline assessment must be documented by
•full Chest/Abdomen/Pelvis CT and/or MRI with Neck CT and/or MRI (for Head and
•Neck primaries) and complete clinical examination after the informed consent
•and prior to enrollment.
•Note: if a patient had laboratory/imaging tests as part of local routine
•guidelines (standard of care) prior to signing informed consent, the procedures
•will be acceptable for screening purpose if they are within the window required
•by the protocol.
•- Disease-free (no loco-regional relapse or distant metastasis); no clinical
•evidence for brain metastases.
•- BRAF mutation status (known or not done)
•- ECOG performance status of 0 or 1.
•- Patient demonstrates adequate organ function as defined in the protocol
•- Women of child bearing potential (WOCBP) must have a negative serum (or
•urine) pregnancy test within 72 hours prior to the first dose of study
•- Patients of childbearing / reproductive potential should use adequate birth
•control methods.
•- Female patients who are breast feeding should discontinue nursing prior to
•the first dose of study treatment and until 120 days after the last dose of
•study drug .
•- Patients who have been disease-free for 5 years, or patients with a history
•of completly resected non-melanoma skin cancer or succesfully treated in situ
•carcinoma are eligible, for example cervical cancer is situ. , Please refer to
•the Diagnosis and Main Criteria for Inclusion in the Protocol for the full list
•of inclusion criteria.

排除标准

•Please see protocol summary section Diagnosis and main criteria for inclusion,
•for full description
•- Mucosal or ocular melanoma.
•- Prior therapy for melanoma including surgery for primary melanoma lesions.
•- history of (non-infectious) pneumonitis that required steroids or current
•pneumonitis. History of or current interstitial lung disease.
•- history of another malignancy or a concurrent malignancy. Exceptions include
•patients who have been disease-free for 5 years, or patients with a history of
•completely resected non-melanoma skin cancer or succesfully treated in situ
•carcinoma are eligible, for example cervical cancer in situ.
•- active autoimmune disease that has required systemic treatment in past 2
•years (i.e. with use of disease modifying agents, corticosteroids or
•immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or
•physiologic corticosteroid replacement therapy for adrenal or pituitary
•insufficiency, etc.) is not considered a form of systemic treatment.
•- active infection requiring therapy.
•- diagnosis of immunodeficiency, no systemic steroid therapy or any other form
•of immunosuppressive therapy within 7 days prior to the first dose of study
•- known history of human immunodeficiency virus (HIV), active Hepatitis B or
•Hepatitis C.
•- treatment with live vaccines within 30 days prior to the first dose of study
•medication are not eligible.
•- prior treatment with any anti-CTLA4 monoclonal antibody or anti-PD-1, or
•PD-L1 or PD-L2 agent.
•- Patient is currently participating and receiving study therapy or has
•participated in a study of an investigational agent and received study therapy
•or used an investigation device within 4 weeks prior to the first dose of
•- patient is or has an immediate family member (e.g., spouse, parent/legal
•guardian, sibling or child) who is investigational site or Sponsor staff
•directly involved with this trial, unless prospective IRB approval (by chair or
•designee) is given allowing exception to this criterion for a specific subject.
•- female patients who are Breast feeding

研究者

发起方

Merck Sharp & Dohme (MSD)

相似试验

进行中（未招募）

1 期

Immunotherapeutic treatment with Pembrolizumab (antibody) in melanoma patients at high risk of recurrence after complete surgical resectioStage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2010): Stage IIIA with metastasis > 1 mmany Stage IIIB or IIIC (no in-transit metastases)MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2014-004944-37-PLMerck Sharp & Dohme LLC, a Subsidiary of Merck & Co. Inc900

进行中（未招募）

1 期

EUCTR2014-004944-37-FIMerck Sharp & Dohme LLC, a Subsidiary of Merck & Co. Inc900

进行中（未招募）

3 期

Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma Group

2023-509136-25-00Merck Sharp & Dohme LLC572

进行中（未招募）

1 期

EUCTR2014-004944-37-DKMerck Sharp & Dohme LLC, a Subsidiary of Merck & Co. Inc900

进行中（未招募）

1 期

EUCTR2014-004944-37-NLMerck Sharp & Dohme LLC, a Subsidiary of Merck & Co. Inc900