Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04848116
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab is an investigational drug in this study.
  • HuMax-IL8 — DRUG
    HuMax-IL8 is an investigational drug in this study.

Study Details

The primary objective of this study is to assess safety and feasibility of pre-operative nivolumab in combination with BMS-986253 (anti-interleukin-8) in patients with squamous cell carcinoma of head and neck (SCCHN) who will undergo surgery.

Key Dates

Start date
Apr 24, 2021
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Nov 30, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Nivolumab (240 mg) + HuMax/BMS-986253 (2400 mg) will be administered as an IV infusion.
  • Experimental: Cohort 2
    Nivolumab (240 mg) + HuMax/BMS-986253 (3600 mg) will be administered as an IV infusion.

Primary Outcome Measure

Safety of neoadjuvant Nivolumab in combination with HuMax [ Time Frame: Up to 100 days after the last dose of study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Johns Hopkins University· Baltimore, MD

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