Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT03049618
Phase
PHASE2
Status
Completed

Conditions

  • ALK Gene Mutation
  • BRAF Gene Mutation
  • EGFR Gene Mutation
  • Head and Neck Squamous Cell Carcinoma
  • Metastatic Head and Neck Carcinoma
  • ROS1 Gene Mutation
  • Recurrent Head and Neck Carcinoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage III Non-Small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Recombinant EphB4-HSA Fusion Protein — BIOLOGICAL
    Given IV

Study Details

This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with non-small cell lung cancer that has spread to other places in the body or head and neck squamous cell cancer that has come back or spread to other places in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients with non-small cell lung or head and neck squamous cell cancer.

Key Dates

Start date
Mar 10, 2017
Status verified
Oct 2025
Primary completion
Sep 4, 2024
Completion
Sep 4, 2024

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Head and Neck Cancer Cohort
    Patients receive pembrolizumab IV over 30 minutes on day 1 and recombinant EphB4-HSA fusion protein IV over 30 minutes on days 1, 8, and 15. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
  • Experimental: Non-Small Cell Lung Cancer Cohort
    Patients receive pembrolizumab IV over 30 minutes on day 1 and recombinant EphB4-HSA fusion protein IV over 30 minutes on days 1, 8, and 15. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 22 months ]

Locations (1)

FacilityCityStateZIP
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CA

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