The purpose of this study is to look at the effectiveness of nivolumab in patients with oral
cavity cancer (OCC) who are about to undergo surgery.
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Locations near you
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Full eligibility criteria for NCT03021993
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Newly diagnosed histologically proven locoregional OCSCC without evidence of distant
metastases and a clinically determined T-stage of 2-4,
Recurrent or persistent histologically proven locoregional OCSCC that was initially
treated with surgery alone, and a clinically determined recurrent T-stage of 2-4.
Note - OCSCC includes the subsites of oral tongue, floor of mouth, gingiva, retromolar
trigone, and buccal mucosa.
Note - To allow sufficient tumor tissue for the immunological analyses, patients with
T-stage 1 OCSCC will be excluded
Greater than or equal to 18 years of age
ECOG performance status of 0 or 1
Screening labs must meet the following criteria and must be obtained within 14 days
prior to registration:
WBC > 2,000/µL
Absolute Neutrophil Count >1,500/µL
Platelets > 100 X 103/µL
Hemoglobin > 9.0 g/dL
Serum creatinine < 1.5 X ULN or CrCl > 40mL/min (if using the Cockcroft-Gault
Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in
mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in
AST/ALT ≤ 3 x ULN
Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have
total bilirubin < 3.0 mg/dL)
WOCBP must use appropriate method(s) of contraception. WOCBP should use an adequate method
to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo
five half-lives) after the last dose of investigational drug.
Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere
to contraception with a failure rate of less than 1% per year for a period of 31 weeks
after the last dose of investigational product.
WOCBP is defined as any female who has experienced menarche and who has not undergone
surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not
postmenopausal. Menopause is defined clinically as 12 consecutive months of amenorrhea in a
woman over 45.
Women of childbearing potential must have a negative serum pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to registration Women
who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
and azoospermic men, are not required to use contraception.
Prior immunotherapy or treatment with another anti PD 1 agent
Prior chemotherapy including Cetuximab or radiation therapy
Previous severe hypersensitivity reaction to another monoclonal antibody
Women who are pregnant, lactating or expecting to conceive
Men who are expecting to father children within the research period
Known history of HIV or AIDS
Positive test for HBV sAg or HCV antibody indicating acute or chronic infection
Unresectable primary tumor or regional disease; presence of distant metastases.
History of pneumonitis or interstitial lung disease
Active, known or suspected autoimmune disease. Note: Subjects are permitted to enroll
if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to
autoimmune condition only requiring hormone replacement, psoriasis not requiring
systemic treatment, or conditions not expected to recur in the absence of an external
Presence of condition requiring systemic treatment with either corticosteroids (> 10
mg daily prednisone or equivalents) or other immunosuppressive medications within 14
days of study drug administration. Inhaled or topical steroids and adrenal replacement
doses > 10 mg daily prednisone equivalents are permitted in the absence of active
All locations for NCT03021993
United States (1)
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
View full eligibility
Tris trial is registered with FDA with number: NCT03021993. The sponsor of the trial is Medical University of South Carolina and it is looking for 17 volunteers for the current phase.
Official trial title: Phase II Trial of Nivolumab, an Anti-PD-1 Monoclonal Antibody, as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
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