CompletedPhase 2

Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer

United States17 participantsStarted 2017-05-30

Plain-language summary

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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Newly diagnosed histologically proven locoregional OCSCC without evidence of distant metastases and a clinically determined T-stage of 2-4,
✓. 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:
✓. Reproductive Status:

✕. 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
✕. Concomitant malignancies except cutaneous squamous cell carcinoma or basal cell carcinoma

Objective Response Rate Using Pathological Response

Timeframe: Time of surgery (day 36 or day 50)

NCT IDNCT03021993

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-15

Results submitted2022-12-14