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Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

NCT05814666 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-01-30

Study results available
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Summary

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.

Conditions

  • HNSCC

Interventions

DRUG

Danvatirsen

Danvatirsen is a STAT3 targeting drug.

DRUG

Pembrolizumab

Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2

Sponsors & Collaborators

  • Flamingo Therapeutics NV

    lead INDUSTRY

Principal Investigators

  • Nabil Saba, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2025-08-14
Completion
2025-08-14
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814666 on ClinicalTrials.gov