Intratumoral Flu Vaccine and Pembrolizumab in Colorectal Cancer

Trial details

Who runs it

Zealand University Hospital

Trial code

EU 2023-503228-17-00

Record updated

2024. október 10.

Original description

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.Read full original descriptionShow less

Combining intratumoral flu vaccine and systemic pembrolizumab in patients with early pMMR colorectal cancer – the FLU-IMMUNE trial.

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.

Inclusion: 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 1; 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.

Exclusion: 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 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; Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9; 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 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 history of allergy to study drug components or a history of severe hypersensitivity reaction to any monoclonal antibody.

EU CTIS 2023-503228-17-00