2023-503228-17-00招募中2 期
Combining intratumoral flu vaccine and systemic pembrolizumab in patients with early pMMR colorectal cancer – the FLU-IMMUNE trial.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- The primary endpoint will be that 50% or more patients achieve a major pathological response (MPR) that will be defined as < 10 % viable cells corresponding to Mandard tumor regression grade 1-2 (MTRG).
研究概览
简要总结
This study aims to investigate whether a combination of local flu vaccine treatment and immunotherapy will cause tumor regression in patients with pMMR type colorectal cancer.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Intervention
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have histologically confirmed localized pMMR stage cT1N0M0 to cT4N2M0 (stage I to III) colorectal carcinoma.
- •Participants must use (or have their partner use) an acceptable method of contraception, during heterosexual activity, while receiving pembrolizumab and for 120 days after the administration.
- •Women of reproductive potential (WORP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to receiving pembrolizumab.
- •Women must not be breastfeeding.
- •Have indication for elective curative intended surgery without neoadjuvant chemotherapy.
- •Be ≥ 18 years of age on the date of signing the informed consent.
- •Provide written informed consent
- •Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Have adequate bone marrow function: Hemoglobin ≥ 6.2 mmol/L or ≥ 10 g/dL Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L
- •Have adequate kidney function defined as Glomerular filtration rate (GFR) ≥ 60 mL/min or creatinine ≤1.5 X upper limit of normal (ULN)
- •Have adequate liver function defined as: Total bilirubin ≤ 1.5 × ULN Alanine aminotransferase (ALT): ≤ 2.5 × ULN Alkaline phosphatase: ≤ 2.5 × ULN
- •Follow the conditions regarding fertility, pregnancy, and lactation: Female and male participants of reproductive potential (for definition refer to appendix 18) must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving pembrolizumab and for 120 days after the administration.
排除标准
- •Has any serious or uncontrolled medical disorder that, in the opinion of the investigator or treating physician, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
- •Acute febrile illness
- •Acute infectious disease
- •Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
- •Has an autoimmune disorder (except thyroiditis with replacement therapy and type I diabetes mellitus).
- •Has received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody/drug specifically targeting T cell co-stimulation or checkpoint pathways.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active chronic or acute Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA is detected).
- •Has a condition 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 disease.
- •Has received live vaccines within 30 days prior to first dose trial treatment (Examples of live vaccines include, but are not limited to: measles, mumps, rubella, chickenpox)
- •Has recently received yellow fever, rabies, BCG, and typhoid (oral) vaccine.
- •Has a history of allergy to study drug components or a history of severe hypersensitivity reaction to any monoclonal antibody
- •Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9
结局指标
主要结局
The primary endpoint will be that 50% or more patients achieve a major pathological response (MPR) that will be defined as < 10 % viable cells corresponding to Mandard tumor regression grade 1-2 (MTRG).
The primary endpoint will be that 50% or more patients achieve a major pathological response (MPR) that will be defined as < 10 % viable cells corresponding to Mandard tumor regression grade 1-2 (MTRG).
次要结局
- Specific safety outcomes including tumor site perforation and delay of surgery, and changes in the recovery as assessed by the QoR-15 questionnaire
- Analysis of tumor samples: Immunohistochemical analysis of CD3+ and CD8+ T cells, spatial protein expression analyses of immune-infiltrated regions of tumors at the different time points, flow cytometry, and full transcriptomic analyses including single cell analysis.
- Analysis of blood samples: flow cytometry and full transcriptomic analyses including single cell analysis.
研究者
Ismail Gögenur
Scientific
Zealand University Hospital
研究点 (2)
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