NL-OMON51364招募中2 期
Pembrolizumab for locally advanced, irresectable, non-metastatic dMMR colorectal cancers. The PUMA study. - PUMA
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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
- •Signed written informed consent;
- •Patients at least 18 years of age;
- •Locally advanced, irresectable adenocarcinoma of the colon or rectum, not
- •amenable to surgery, or for which induction therapy is required to reconsider
- •surgery, or where free margins can only be obtained by major extension of the
- •surgical procedure, as defined by one of the following:
- •o Invasion of the duodenum, stomach, spleen or pancreatic head, for which major
- •extension of the surgical procedure would be required to obtain free margins,
- •and/or for which the chances of positive resection margins are high
- •o Invasion or encasement of major blood vessels (superior mesenteric vessels,
- •iliac vessels, portal vein)
- •o Invasion or encasement of the ureter
- •Histologically or cytologically confirmed microsatellite instability-high
- •(MSI-H) or MMR-deficient (dMMR) status
- •No signs of distant metastases on CT-scan and physical examination; patients
- •may not be eligible for first-line treatment with pembrolizumab according to
- •Patients may not be eligible for standard of care first-line pembrolizumab
- •for metastatic disease
- •Patients may not be potentially eligible for the NICHE study: patients with
- •primarily resectable disease, for which relatively minor extension of the
- •procedure is required to acieve free margins, such as but not limited to a
- •small bowel segment, abdominal wall
- •ECOG performance status of 0 or 1. Evaluation of ECOG is to be performed
- •within 7 days prior to the first dose of study intervention;
- •Screening laboratory tests must meet the criteria as defined in Table 1 and
- •should be obtained within 10 days prior to the start of study intervention:
- •Absolute neutrophil count (ANC) >=1500/µL; Platelets >=100 000/µL; Hemoglobin
- •>=9.0 g/dL or >=5.6 mmol/L, Creatinine OR Measured or calculated creatinine
- •clearance (GFR can also be used in place of creatinine or CrCl) <=1.5 × ULN OR
- •>=30 mL/min for participant with creatinine levels >1.5 × institutional ULN;
- •Total bilirubin <=1.5 ×ULN OR direct bilirubin <=ULN for participants with total
- •bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) <=2.5 × ULN;
- •International normalized ratio (INR) OR prothrombin time (PT) <=1.5 × ULN unless
- •participant is receiving anticoagulant therapy as long as PT or aPTT is within
- •therapeutic range of intended use of anticoagulants; Activated partial
- •thromboplastin time (aPTT) <=1.5 × ULN unless participant is receiving
- •anticoagulant therapy as long as PT or aPTT is within therapeutic range of
- •intended use of anticoagulants;
- •A male participant must agree to use a contraception as detailed in Appendix
- •2 of this protocol during the treatment period and for at least 200 days (90
- •days plus the time required for pembrolizumab to undergo five half-lives) after
- •the last dose of study treatment and refrain from donating sperm during this
- •Women of childbearing potential must have a negative serum or urine pregnancy
- •test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours
- •prior to registration (see appendix 2). If the urine test is positive or cannot
- •be confirmed as negative, a serum pregnancy test will be required;
- •A female participant is eligible to participate if she is not pregnant (see
- •appendix 2), not breastfeeding, and at least one of the following conditions
排除标准
- •Previous treatment with immune checkpoint inhibitors targeting including but
- •not limited to CTLA-4, PD-1 or PD-L1;
- •Previous treatment with chemotherapy for the disease under study;
- •Prior radiotherapy for the disease under study;
- •Prior radiotherapy for other indications than the disease under study within
- •2 weeks of start of study intervention. Participants must have recovered from
- •al radiation-related toxicities, not require corticosteroids, and not have had
- •radiation pneumonitis.
- •History of (non-infectious) pneumonitis/interstitial lung disease that
- •required steroids or has current pneumonitis/interstitial lung disease;
- •Allergies and Adverse Drug Reaction
- •o History of allergy to study drug components
- •o History of severe hypersensitivity reaction to any monoclonal antibody
- •Intercurrent illnesses, including but not limited to infections, unstable
- •angina pectoris;
- •Known history of Human Immunodeficiency Virus (HIV) infection and 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.
- •Underlying medical conditions that, in the investigator*s opinion, will make
- •the administration of the study drug hazardous or obscure the interpretation of
- •toxicity determination of adverse events;
- •Active autoimmune disease requiring systemic treatment in the past 2 years;,
- •or other medical conditions requiring systemic steroid or immunosuppressive
- •medications, Replacement therapy (e.g., thyroxine, insulin, or physiologic
- •corticosteroid replacement therapy for adrenal or pituitary insufficiency,
- •etc.) is not considered a form of systemic treatment and is allowed.
- •Diagnosis of immunodeficiency or conditions requiring systemic treatment with
- •either corticosteroids (> 10 mg daily prednisone equivalents) or other
- •immunosuppressive medications within 14 days of study drug administration.
- •Inhaled or topical steroids and adrenal replacement doses > 10 mg daily
- •prednisone equivalents are permitted in the absence of active autoimmune
- •Live vaccines in the 4 weeks prior to inclusion;
- •History of uncontrolled medical or psychiatric illness;
- •Psychological, familial, sociological or geographical condition potentially
- •hampering compliance with the study protocol and follow-up schedule;
- •Current pregnancy or breastfeeding;
- •Active malignancies other than disease under study within 3 years prior to
- •inclusion, except for malignancies with a negligible recurrence rate (e.g. <10%
- •in 5 years);
- •Allogenic tissue/solid organ transplant.
研究者
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