NL-OMON53535招募中2 期
eo-adjuvant Pembrolizumab as an alternative treatment for MMRd uterine cancer, a phase II efficacy study - PAM-II
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
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
- •- Female participants who are at least 18 years of age on the day of signing
- •informed consent with histologically confirmed primary diagnosis of G3/CC
- •MMRd uterine cancer who are intended to be treated with hysterectomy.
- •- A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, is not a woman of childbearing potential (WOCBP) or agrees to
- •follow contraceptive guidance during the treatment period and at least
- •until standard-of-care hysterectomy.
- •- The participant (or legally acceptable representative if applicable) provides
- •written informed consent for the trial.
排除标准
- •- A WOCBP who has a positive serum pregnancy test at screening.
- •- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent
- •or with an agent directed to another stimulatory or co-inhibitory T-cell
- •receptor (eg, CTLA-4, OX-40, CD137).
- •- Has received prior systemic anti-cancer therapy including investigational
- •agents within 4 weeks [could consider shorter interval for kinase inhibitors or
- •other short half-life drugs] prior to allocation.
- •- Has received prior radiotherapy within 2 weeks of start of study treatment or
- •radition-related toxicities requiring corticosteroids. Note: Two weeks or fewer
- •of palliative radiotherapy for non-CNS disease with a 1-week washout is
- •- Has received a live vaccine or live-attenuated vaccine within 30 days before
- •to the first dose of study intervention. Administration of killed vaccines and
- •Covid 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 drug.
- •- Has a known additional malignancy that is progressing or has required active
- •treatment within the past 3 years. Note: Participants with basal cell
- •carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in
- •situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone
- •potentially curative therapy are not excluded.
- •- Has known active CNS metastases and/or carcinomatous meningitis. Participants
- •with previously treated brain metastases may participate provided they are
- •radiologically stable, i.e. without evidence of progression for at least 4
- •weeks by repeat imaging (note that the repeat imaging should be performed
- •during study screening), clinically stable and without requirement of steroid
- •treatment for at least 14 days prior to first dose of study treatment.
- •- Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its
- •excipients.
- •- Has active autoimmune disease that has required systemic treatment in the
- •past 2 years except replacement therapy (eg., thyroxine, insulin, or
- •physiologic corticosteroid).
- •- Has a history of (non-infectious) pneumonitis that required steroids or has
- •current pneumonitis.
- •- Has an active infection requiring systemic therapy.
- •- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV
- •testing is required unless mandated by local health authority.
- •- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen
- •[HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA
- •[qualitative] is detected) infection. Note: no testing for Hepatitis B and
- •Hepatitis C is required unless mandated by local health authority.
- •- Has not adequately recovered from major surgery or has ongoing surgical
- •complications.
- •- Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the study, interfere with the
- •subject*s participation for the full duration of the study, or is not in the
- •best interest of the subject to participate, in the opinion of the treatin
研究者
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