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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
EU CTIS ID: 2025-522500-24-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older
- 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 8.0 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
You likely can't join if
- Inoperable OSCC (Stage IVB)
- 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)
- Patients who are pregnant or breastfeeding
- History of allergy to study drug components and/or history of severe hypersensitivity to any monoclonal antibody
- Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion
- Distantly metastasized (Stage IVC) OSCC
See the full eligibility criteria
Who can join
- 18 years of age or older
- 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 8.0 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
- No prior radiotherapy to the head and neck
- 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.
What rules you out
- Inoperable OSCC (Stage IVB)
- 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)
- Patients who are pregnant or breastfeeding
- History of allergy to study drug components and/or history of severe hypersensitivity to any monoclonal antibody
- Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion
- Distantly metastasized (Stage IVC) OSCC
- Prior irradiation in the head and neck area.
- 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.
- Active human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.