IMCISION: Towards organ preservation and cure via ultra-short immunotherapy in advanced oral cancer. The IMCISION II trial, an investigator-initiated multicentre randomised phase 3 trial

Trial details

Who runs it

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Trial code

EU 2025-522500-24-00

Record updated

2026. szeptember 25.

Original description

To determine the rate of patients with a CCR with organ preservation of the face and oral cavity at two years of FU without compromising clinical outcome for all patients.Read full original descriptionShow less

IMCISION: Towards organ preservation and cure via ultra-short immunotherapy in advanced oral cancer. The IMCISION II trial, an investigator-initiated multicentre randomised phase 3 trial (M24IMS)

To determine the rate of patients with a CCR with organ preservation of the face and oral cavity at two years of FU without compromising clinical outcome for all patients.

Inclusion: 18 years of age or older;  No prior radiotherapy for the current primary tumour; Prior surgery for the current primary tumour is allowed; Patients willing and able to understand the Dutch study information and protocol requirements and comply with the treatment/intervention schedule, scheduled visits, and other requirements of the study; Primary advanced oral cavity squamous cell carcinoma (HNSCC) o Stage III-IVA according to TNM version 9.0 of the UICC/AJCC staging manual; Primary tumour site: o Malignant neoplasm of other and unspecified parts of tongue (C02.0-C02.3, C02.8-9) o Malignant neoplasm of gum (C03) o Malignant neoplasm of floor of mouth (C04) o Malignant neoplasm of hard palate (C05.0, C05.8-9) o Malignant neoplasm of other and unspecified parts of mouth (C06); Indication for SOC*; No prior systemic oncological therapy for the current primary tumour; No immunosuppression; World Health Organisation (WHO) performance status of 0-2; Screening laboratory values must meet the following criteria: o WBC ≥ 2.0x109 /L o Neutrophils ≥1.5x109 /L o Platelets ≥100 x109 /L o Hemoglobin ≥5.5 mmol/L o Creatinine ≤1.5x upper limit of normal (ULN) o AST ≤ 1.5 x ULN o ALT ≤ 1.5 x ULN o Bilirubin ≤1.5 X ULN (except patients with Gilbert Syndrome, who are eligible when total bilirubin < 3.0 mg/dL) o Women of child-bearing potential (WOCBP) must use appropriate method(s) of con-traception. They should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required time for nivolumab to undergo five x T1/2, ipilimumab has a much shorter T1/2) after the last dose of the IMP. o WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) prior to the start of ICB.

Exclusion: Prior systemic oncological therapy for the current primary tumour; Prior radiotherapy for the current primary tumour; Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids (up to 10 mg of prednisone per day is allowed); Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion; Prior anti-PD(L)1 or anti-CTLA4 immune checkpoint-blockade; Prior diagnosed malignancies, except malignancies with a 2 year survival rate of over >90% (eg. certain skin cancers, low-grade prostate carcinoma) and where treatment does not interfere with the treatment of patients included in this trial; Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C antibody (HCV Ab); Subjects with any active autoimmune disease or a documented history of autoimmune disease, except: o Subjects with vitiligo o Resolved childhood asthma/atopy o Residual hypothyroidism due to an autoimmune condition requiring only hormone replacement o Psoriasis without the need for systemic treatment o Any condition not expected to recur in the absence of an external trigger; Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity or AEs; History of allergy to study drug components and/or history of severe hypersensitivity to any monoclonal antibody; Active human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); Inoperable OSCC (Stage IVB); Patients who are pregnant or breastfeeding; Distantly metastasized (Stage IVC) OSCC.

EU CTIS 2025-522500-24-00