Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Flamingo Therapeutics NV
Study ID
NCT05814666
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Danvatirsen — DRUG
    Danvatirsen is a STAT3 targeting drug.
  • Pembrolizumab — DRUG
    Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2

Study Details

Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.

Key Dates

Start date
May 30, 2023
Status verified
Dec 2025
Primary completion
Aug 14, 2025
Completion
Aug 14, 2025

Study Design

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

Arms

  • Experimental: Danvatirsen plus pembrolizumab
    Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose.
  • Active Comparator: Pembrolizumab
    Pembrolizumab IV every 3 weeks

Primary Outcome Measure

Confirmed ORR [ Time Frame: Up to 18 months ]

Locations (21)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85719-
University of California Irvine (UCI)IrvineCalifornia92617-
TMPN Hunt Cancer CareTorranceCalifornia90505-
University of California Los AngelesWestwood, Los AngelesCalifornia90024-
University of Colorado Hospital (UCH) Anschutz Cancer PavilionAuroraColorado80045-
Miami Cancer InstituteMiamiFlorida33176-
Emory University Hospital MidtownAtlantaGeorgia30308-
University of Illinois Cancer CenterChicagoIllinois60612-
AMR Kansas City OncologyMerriamKansas66204-
University of Kansas Medical CenterWestwoodKansas66205-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
University of Maryland Baltimore, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Morristown Medical CenterMorristownNew Jersey07960-
Mount SinaiNew YorkNew York10029-
Stony Brook Cancer CenterStony BrookNew York11794-
The Christ Hospital Cancer CenterCincinnatiOhio45219-
University of Cincinnati Medical CenterCincinnatiOhio45229-
University Hospitals ClevelandClevelandOhio44106-
Prisma Health Cancer InstituteGreenvilleSouth Carolina29605-
UT Southwestern Medical Center/Simmons Comprehensive Cancer CenterDallasTexas75390-

Related coverage on Hipa.ai

Find similar trials in Tucson, AZ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of Arizona Cancer Center· Tucson, AZUniversity of California Irvine (UCI)· Irvine, CATMPN Hunt Cancer Care· Torrance, CAUniversity of California Los Angeles· Westwood, Los Angeles, CAUniversity of Colorado Hospital (UCH) Anschutz Cancer Pavilion· Aurora, COMiami Cancer Institute· Miami, FL

Related Studies