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NOCANO: Nivolumab as neoadjuvant immunotherapy for patients with Oral CANcer and identification of response-predictive biomarkers in tumour draining lymph NOdes
EU CTIS ID: 2025-521006-18-00
What this study is testing
To evaluate the efficacy of two doses neoadjuvant nivolumab in reducing primary tumour size at the time of surgery.
- Therapeutic exploratory (Phase II)
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
- The subject is willing to participate and has given their written and dated consent to participate in the trial.
- Naïve to immunotherapy.
- ≥ 18 years of age* at the time of signing the informed consent.
- Primary histologically or cytologically confirmed OSCC classified according to the ICD-10 classification: C02.0, C02.1, C02.2, C02.3, C02.8 C02.9, C03.0, C03.1, C03.9, C04.0, C04.1, C04.8, C04.9, C06.0, C00.3, C00.4, C05.0, C06.1, C06.2, C06.8, C06.9.
- Stage T2-4 N0-3 M0 according to the UICC TNM classification of Malignant Tumours.
- The subject is planned for curative surgery as the primary treatment.
You likely can't join if
- Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal.
- History of systemic hypersensitivity or anaphylaxis to other monoclonal antibodies including any excipient.
- Active, known, or suspected autoimmune disease or inflammatory disease (e.g. lupus, inflammatory bowel disease [e.g. colitis or Crohn’s disease]), diverticulitis, rheumatoid arthritis, Sarcoidosis, Wegener syndrome, Grave’s disease, uveitis, etc.) that has required systemic treatment with immune modifying agents in the last 2 years (e.g. replacement therapy such as thyroxine, insulin or physiological corticosteroids is not an exclusion criteria).
- Presence of condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisolone equivalents) or other immunosuppressive medication within 14 days before the start of nivolumab therapy.
- Severe asthma exacerbation requiring the admission to hospital with systemic CS within 4 weeks before Screening visit.
- Known significant respiratory disease, including, but not limited to, pneumonitis, interstitial lung disease (ILD), COPD, cystic fibrosis.
See the full eligibility criteria
Who can join
- The subject is willing to participate and has given their written and dated consent to participate in the trial.
- Naïve to immunotherapy.
- ≥ 18 years of age* at the time of signing the informed consent.
- Primary histologically or cytologically confirmed OSCC classified according to the ICD-10 classification: C02.0, C02.1, C02.2, C02.3, C02.8 C02.9, C03.0, C03.1, C03.9, C04.0, C04.1, C04.8, C04.9, C06.0, C00.3, C00.4, C05.0, C06.1, C06.2, C06.8, C06.9.
- Stage T2-4 N0-3 M0 according to the UICC TNM classification of Malignant Tumours.
- The subject is planned for curative surgery as the primary treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
What rules you out
- Distant metastases (pathologically proven, radiologic or clinical evidence of distant metastatic disease). This includes all diseases below the clavicles, as well as disease metastatic to the bone, brain, or in the spinal canal.
- History of systemic hypersensitivity or anaphylaxis to other monoclonal antibodies including any excipient.
- Active, known, or suspected autoimmune disease or inflammatory disease (e.g. lupus, inflammatory bowel disease [e.g. colitis or Crohn’s disease]), diverticulitis, rheumatoid arthritis, Sarcoidosis, Wegener syndrome, Grave’s disease, uveitis, etc.) that has required systemic treatment with immune modifying agents in the last 2 years (e.g. replacement therapy such as thyroxine, insulin or physiological corticosteroids is not an exclusion criteria).
- Presence of condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisolone equivalents) or other immunosuppressive medication within 14 days before the start of nivolumab therapy.
- Severe asthma exacerbation requiring the admission to hospital with systemic CS within 4 weeks before Screening visit.
- Known significant respiratory disease, including, but not limited to, pneumonitis, interstitial lung disease (ILD), COPD, cystic fibrosis.
- Prior history or evidence of active ILD or non-infectious pneumonitis that required steroids.
- Known or suspected condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.
- Recent history of myocardial infarction, cardiac arrhythmia, unstable angina pectoris, transient ischemic attack, or a known history of a hypercoagulable disease.
- Known hepatitis B virus (HBV) and/or hepatitis C virus (HCV) acute or chronic infection. If suspected, tests for hepatitis B surface antigen (HBs Ag) and/or HCV antibody (HCV Ab) confirmed by HCV ribonucleic acid (RNA) are required.
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) or positive HIV 1/2 serology test result if suspected.
- Active malignancy requiring concurrent treatment or history of another primary malignancy.
- Active tuberculosis (TB), non-tuberculous mycobacterial infection, a history of incompletely treated TB. TB test if suspected.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections (e.g. TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis or aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting a compromised immune system status, as judged by the Investigator.
- Uncontrolled concurrent medical disorder affecting organ function and in the opinion of the Investigator may increase the risk for the subject or may interfere with the treatment and thus affect the study results or assessment.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Known or suspected heavy drinking and/or drug use.
- In the opinion of the Investigator, the subject is unfit or unsuitable to receive neoadjuvant nivolumab, whatever the reason, including medical or clinical condition.
- Any mental inability (e.g. dementia), reluctance or language difficulties that result in difficulty understanding the meaning of participation in the clinical trial and following the study protocol and instructions.
- Lack of adherence to the study protocol and instructions given by the Investigator.
- Premature withdrawal by the Investigator/Sponsor due to safety or any other reason.
- Revoked consent.
- History of radio- and/or chemotherapy.
- Pregnant, breastfeeding, planning pregnancy or refusal to use highly effective contraception method during the treatment period and for at least 5 months after the last dose.
- History of systemic treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- Prior organ transplantation.
- Treatment with a live (attenuated) vaccine within 4 weeks before Screening visit.
- Initiation of allergen immunotherapy within 3 months prior Screening visit or a plan to begin therapy during the trial.
- Known or suspected systemic hypersensitivity to the active substance nivolumab including any of the OPDIVO™ excipients.
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, 18-64 years, 65+ 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.