Suspended

PEMDA-HNDanvatirsen and Pembrolizumab Combination for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Study Aim

This phase 2 study aims to determine the effectiveness of the combination of Danvatirsen and Pembrolizumab, compared to Pembrolizumab alone, in treating recurrent or metastatic head and neck squamous cell carcinoma, by evaluating the response rate of the tumor to the treatment.

What is being tested

Danvatirsen

+ Pembrolizumab

Drug
Who is being recruted

Squamous Cell Carcinoma of Head and Neck+5

+ Carcinoma

+ Carcinoma, Squamous Cell

Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorFlamingo Therapeutics NV
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 30, 2023

Actual date on which the first participant was enrolled.

This study focuses on a type of cancer known as recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The main goal is to test the effectiveness and safety of a combination treatment using danvatirsen and pembrolizumab, compared to using pembrolizumab alone. This research is important as it aims to find a better first-line treatment for this type of cancer, potentially improving patient care and outcomes. In this study, participants are randomly assigned to one of two groups. One group receives both danvatirsen and pembrolizumab, while the other group receives only pembrolizumab. Treatment is given in 21-day cycles and continues until a reason for discontinuation arises, or up to a maximum of 24 months. Participants' progress is monitored through regular tumor assessments every 6 weeks. The study measures the response rate of the tumor to the treatment, looking at both partial responses and complete responses. After stopping the study treatment, patients will have follow-up visits for safety checks and to monitor any adverse effects.

Official TitleAn Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT05814666
Principal SponsorFlamingo Therapeutics NV
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Squamous Cell Carcinoma of Head and NeckCarcinomaCarcinoma, Squamous CellHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

13 inclusion criteria required to participate
Must have given written informed consent (signed and dated).
Aged ≥18 years at the time of informed consent.
Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Presence of measurable tumor per RECIST v1.1 criteria.
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18 exclusion criteria prevent from participating
Prior therapy for metastatic HNSCC.
Has disease suitable for local therapy with curative intent.
Primary tumor of the nasopharynx.
Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
Pembrolizumab IV every 3 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Suspended

TMPN Hunt Cancer Care

Torrance, United StatesOpen TMPN Hunt Cancer Care in Google Maps
Suspended

University of California Los Angeles

Westwood, Los Angeles, United States
Suspended

University of Colorado Hospital (UCH) Anschutz Cancer Pavilion

Aurora, United States
Suspended

Miami Cancer Institute

Miami, United States
Suspended32 Study Centers