BridgeMD
ROCinIT
EU CTIS ID: 2025-523617-29-01
What this study is testing
Tolerability and efficacy of treating locally advanced Resectable Oral Cancer with neoadjuvant INtratumoral anti-CTLA4 ImmunoTherapy combined with systemic anti-PD-1 (ROCinIT).
- 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
- Have a histologically confirmed diagnosis of T2–T4, N0–N3b, M0 disease and be scheduled for treatment with curative intent, including surgical resection.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab w/ ipilimumab and who are sexually active with WOCBP will be instructed to adhere to contraception during the study and for 31 weeks after the last dose of the investigational product.
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older on day of signing informed consent.
- No immunosuppressive medication within 6 months prior to study inclusion.
- No hard-drug abuse.
You likely can't join if
- Has distant metastasis.
- Is pregnant or breastfeeding, or expecting to conceive children within the projected dura-tion of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check-point pathways.
- Has known active Hepatitis B or C.
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has a known current additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
See the full eligibility criteria
Who can join
- Have a histologically confirmed diagnosis of T2–T4, N0–N3b, M0 disease and be scheduled for treatment with curative intent, including surgical resection.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab w/ ipilimumab and who are sexually active with WOCBP will be instructed to adhere to contraception during the study and for 31 weeks after the last dose of the investigational product.
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older on day of signing informed consent.
- No immunosuppressive medication within 6 months prior to study inclusion.
- No hard-drug abuse.
- Must agree to provide tissue from fresh tumor biopsy pretreatment, on-treatment biop-sy (when feasible) and from the surgical resection material to determine the actual PD-L1 status and perform histopathological examination for response, as well as immunomoni-toring/DNA/RNA profiling.
- Have a performance status of 0-1 on the Eastern Cooperative Oncology Group Perfor-mance Scale
- Demonstrate adequate organ function. All screening labs should be performed within 2 weeks before any study imaging procedures are performed.
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contra-ception during the study and for 23 weeks after the last dose of nivolumab. Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
What rules you out
- Has distant metastasis.
- Is pregnant or breastfeeding, or expecting to conceive children within the projected dura-tion of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check-point pathways.
- Has known active Hepatitis B or C.
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has a known current additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- If subject received major surgery for any other reason, they must have recovered ade-quately from the toxicity and/or complications from the intervention prior to starting ther-apy.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day -5. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily predni-sone equivalent, are permitted in the absence of active autoimmune disease.
- Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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.
Explore other conditions
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.