Neoadjuvant Nivolumab for Oral Cancer Combined With FDG and Anti-PD-L1 PET/CT Imaging for Response Prediction

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT03843515
Phase
PHASE1
Status
Unknown

Conditions

  • Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Neoadjuvant nivolumab flat dose 400mg

Study Details

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

Key Dates

Start date
Apr 11, 2019
Status verified
Oct 2021
Primary completion
Nov 30, 2021
Completion
Aug 31, 2022

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant nivolumab
    All subject will receive 400mg flat dose nivolumab in the neoadjuvant setting

Primary Outcome Measure

(Serious) adverse events [ Time Frame: untill 100 days after last study drug administration ]

Related Studies