Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT02642809
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Provided by Merck.
  • Brachytherapy — RADIATION
    It will be delivered using a high-dose-rate Ir-192 afterloader via a dedicated esophageal applicator.

Study Details

The investigators propose to treat patients with metastatic esophageal cancers and dysphagia with two fractions of brachytherapy followed by pembrolizumab. The brachytherapy is hypofractionated and will provide a radiation dose of sufficient intensity to induce the release of tumor-derived antigens and trigger an antitumor immune response. The simplicity of the design should maximize the chance to examine the hypothesis that radiotherapy can induce an immune response, which can then be augmented by pembrolizumab treatment. Success in this study would provide the impetus to conduct further trials aimed at developing this unique strategy as a more broadly applicable therapeutic option in the treatment of patients suffering from these deadly cancers, and will provide important mechanistic insights into the relationship between radiation treatment and immune therapy augmentation.

Key Dates

Start date
Jun 8, 2016
Status verified
Feb 2026
Primary completion
Sep 24, 2020
Completion
Aug 3, 2021

Study Design

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

Arms

  • Experimental: Pembrolizumab and Brachytherapy
    * Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions. * Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks. * Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.

Primary Outcome Measure

Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events [ Time Frame: Through 30 days after completion of treatment (median length of adverse event follow-up 106 days, full range 42-1023 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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Find similar trials in St Louis, MO

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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