A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Chicago
Study ID
NCT02841748
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    200mg, every three weeks, iv, x 1 year
  • Placebo — DRUG
    iv, every three weeks, x 1 year

Study Details

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

Key Dates

Start date
May 10, 2017
Status verified
May 2026
Primary completion
Feb 11, 2025
Completion
Oct 23, 2025

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    200mg, every three weeks, iv, x 1 year
  • Experimental: Placebo
    iv, every 3 weeks, x 1 year

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 2 years (PFS at 2 years) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Rush University Medical CenterChicagoIllinois60612-
University of Chicago Medical CenterChicagoIllinois60637-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Related coverage on Hipa.ai

Find similar trials in Atlanta, GA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Emory University Winship Cancer Institute· Atlanta, GARush University Medical Center· Chicago, ILUniversity of Chicago Medical Center· Chicago, ILUniversity of Pennsylvania· Philadelphia, PA

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