NL-OMON50077
Completed
Not Applicable
Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with [18F]BMS-986192 / [18F]-FDG PET imaging and immunomonitoring for response prediction. - NeoNivo
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histologically confirmed diagnosis of locally advanced oral cancer (stage
- •III/IV) which is planned for treatment with curative intent includiing surgical
- •\- Must provide tissue from fresh tumor biopsy pretreatment and from the
- •surgical resection material to determine actual PD\-L1 status and perform
- •immunomonitoring and DNA/RNA profiling.
- •\- Willing to allow up to two additional biopsies when baseline \[18F]BMS\-986192
- •PET /\[18F]\-FDG PET scans show heterogeneous and/or discrepant uptake.
- •\- ECOG performance scale 0\-1
- •\- Have adequate organ function (hematological, renal and hepatic) as
- •demonstrated by screening laboratory test.
Exclusion Criteria
- •\- 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 or synchronous head and neck squamous cell
- •\- If subject received major surgery for any other reason, they must have
- •recovered adequately from the toxicity and/or complications from the
Outcomes
Primary Outcomes
Not specified
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