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

Amsterdam UMC, location VUmc0 sites15 target enrollmentFebruary 25, 2019

ConditionsStage III/IV resectable oral squamous cell carcinoma MedDRA version: 20.0 Level: LLT Classification code 10030961 Term: Oral cancer stage unspecified System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOpdivo

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Stage III/IV resectable oral squamous cell carcinoma
Sponsor: Amsterdam UMC, location VUmc
Enrollment: 15
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Amsterdam UMC, location VUmc

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1\. Have a histologically confirmed diagnosis of locally advanced oral cancer (stage III/IV) which is planned for treatment with curative intent including surgical resection.
•2\. Be willing and able to provide written informed consent/assent for the trial.
•3\. 18 years of age or older on day of signing informed consent.
•4\. Must agree to provide tissue from fresh tumor biopsy pretreatment and from the surgical resection material to determine the actual PD\-L1 status and perform immunomonitoring/DNA/RNA profiling.
•5\. Willing to allow up to two additional biopsies when baseline \[18F]BMS\-986192 PET /\[18F]\-FDG PET scans show heterogeneous and/or discrepant uptake.
•6\. Have a performance status of 0\-1 on the ECOG Performance Scale.
•7\. Demonstrate adequate organ function as defined in Table 1\. All screening labs should be performed within 2 weeks before any study imaging procedures are performed.
•Table 1 Adequate Organ Function Laboratory Values
•System Laboratory Value

Exclusion Criteria

•A subject who meets any of the following criteria will be excluded from participation in this study:
•1\. 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.
•2\. Has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0\.
•3\. 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.
•4\. If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•5\. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0\. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
•6\. 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.
•7\. Has evidence of interstitial lung disease or active, non\-infectious pneumonitis.
•8\. Has an active infection requiring systemic therapy.
•9\. 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.