Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03878979
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).

Key Dates

Start date
Jul 8, 2019
Status verified
Nov 2024
Primary completion
Oct 17, 2023
Completion
Oct 17, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Newly diagnosed SCCHN
    One dose of nivolumab given about 4 weeks before surgical resection (removal) of a newly diagnosed SCCHN.
  • Experimental: Recurrence of SCCHN
    One dose of nivolumab given about 4 weeks before surgical resection (removal) of SCCHN which has recurred.

Primary Outcome Measure

Safety as Measured by Number of Participants With Drug-related Adverse Events [ Time Frame: Up to 100 days after the last dose of nivolumab or 30 days after surgery, whichever is longer (up to 100 days per participant) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

Related Studies