1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT04150900
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Bavituximab — DRUG
    Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
  • Pembrolizumab — DRUG
    Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

Study Details

This phase II single arm study is being done to determine if bavituximab could potentially synergize with PD-1 inhibitor therapy to generate an effective anti-tumor immune response in patients with recurrent/metastatic squamous cell head and neck cancer (HNSCC) who progressed on a PD-1 inhibitor.

Key Dates

Start date
Jan 13, 2020
Status verified
Feb 2026
Primary completion
Sep 1, 2024
Completion
Jan 1, 2027

Study Design

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

Arms

  • Experimental: Pembrolizumab + Bavituximab
    Pembro and Bavituximab for progressive recurrent/metastatic squamous cell carcinoma of head and neck

Primary Outcome Measure

CR+PR [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 55 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201-

Related coverage on Hipa.ai

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By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
University of Maryland Medical Center· Baltimore, MD

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