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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
PEMDA-HN Trial Summary
This trial tests a new drug combo to treat head and neck cancer, compared to a single drug. 2/3 get both drugs, 1/3 only one.
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.Check my eligibility
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.See study design
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.
PEMDA-HN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed ORR
Secondary outcome measures
Area under the plasma concentration-time curve
DCR & CR Rate
DOR
+9 morePEMDA-HN 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 2
~2010
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
702 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who is either surgically sterile or I agree to use birth control.My tumor shows high PD-L1 levels according to an FDA-approved test.I have received treatment for advanced head and neck cancer before.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My condition can be treated with the goal of curing it.I haven't had radiation or local treatments in the last 2 weeks.I have an autoimmune disease treated with medication.I have HIV but have been stable on my medication for at least 4 weeks.I am currently on medication for an infection.I have had lung inflammation treated with steroids or have it now.I have had cancer before.I have brain metastases or leptomeningeal disease, treated or untreated.I haven't taken any experimental drugs or used new medical devices recently.I have a serious heart condition.I am not pregnant or breastfeeding, and if of childbearing potential, I agree to use birth control.I am 18 years old or older.I have recovered from all side effects of my previous treatments.My organs are functioning well enough for treatment.My cancer is a type of head or neck cancer that cannot be cured with surgery or radiation.I have an active hepatitis B or C infection.I have not received a live vaccine in the last 30 days.My cancer originates in the nasopharynx.I am not on high-dose steroids or have a known weak immune system.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Danvatirsen plus pembrolizumab
- Group 2: Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively enrolled in this trial?
"Affirmative. According to clinicaltrials.gov, the trial which was initially listed on June 30th 2023 is still actively recruiting patients. As of now, 81 individuals need to be enrolled from one medical site."
Answered by AI
Are there any adverse effects to taking Danvatirsen and pembrolizumab concurrently?
"With a score of two, our team at Power estimates Danvatirsen plus pembrolizumab is safe to use. This Phase 2 trial offers preliminary evidence that the drug is secure but has not yet demonstrated any efficacy."
Answered by AI
Are participants still being accepted into this medical trial?
"Yes, the information from clinicaltrials.gov reveals that this research endeavor is actively looking for volunteers. It was first posted on June 30th, 2023 and modified most recently on May 22nd, 2023 with the intent of recruiting 81 patients to one site."
Answered by AI
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