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Antisense Oligonucleotide

Danvatirsen + Pembrolizumab for Head and Neck Cancer (PEMDA-HN Trial)

Phase 2
Recruiting
Led By Ezra Cohen, MD
Research Sponsored by Flamingo Therapeutics NV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30months
Awards & highlights

Summary

This trial is testing danvatirsen with pembrolizumab in patients with head and neck cancer that has returned or spread. Danvatirsen aims to stop cancer growth, and pembrolizumab helps the immune system attack the cancer.

Who is the study for?
This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma that can't be cured by surgery. They must have a life expectancy of at least 3 months, measurable tumor growth, PD-L1 expression in the tumor, good organ function, and agree to birth control if necessary. Excluded are those with curable disease by local therapy, prior metastatic treatment, certain heart diseases, previous immunotherapy drugs like anti-PD-1/L1/L2 agents.
What is being tested?
The study compares two treatments: Danvatirsen combined with Pembrolizumab versus Pembrolizumab alone for first-line treatment of advanced head and neck cancer. Patients will be randomly assigned to either receive both drugs or just Pembrolizumab in an open-label Phase II trial.
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs (like pneumonitis), infusion reactions from the drug administration process itself, fatigue due to immune system activation by the drugs, and possibly other common chemotherapy-associated risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed ORR
Secondary study objectives
Area under the plasma concentration-time curve
DCR & CR Rate
DOR
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Danvatirsen plus pembrolizumabExperimental Treatment2 Interventions
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: PembrolizumabActive Control1 Intervention
Pembrolizumab IV every 3 weeks after the Danvatirsen dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danvatirsen
2019
Completed Phase 2
~90
Pembrolizumab
2017
Completed Phase 3
~2850

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Danvatirsen, an antisense oligonucleotide targeting STAT3, works by inhibiting a key transcription factor involved in cancer cell survival and immune evasion, thereby reducing tumor growth and enhancing immune response. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway that cancer cells use to evade immune detection, reactivating T-cells to recognize and destroy cancer cells. These targeted mechanisms are important for HNSCC patients as they disrupt cancer cell survival and boost the immune system's ability to fight the cancer, potentially improving treatment outcomes.

Find a Location

Who is running the clinical trial?

Flamingo Therapeutics NVLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Ezra Cohen, MDPrincipal InvestigatorMoores Cancer Center at UC San Diego Health
13 Previous Clinical Trials
682 Total Patients Enrolled

Media Library

Danvatirsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05814666 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Danvatirsen plus pembrolizumab, Pembrolizumab
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Danvatirsen Highlights & Side Effects. Trial Name: NCT05814666 — Phase 2
Danvatirsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814666 — Phase 2
~24 spots leftby May 2025