Danvatirsen + Pembrolizumab for Head and Neck Cancer
(PEMDA-HN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or have received a live vaccine recently, you may not be eligible to participate.
What makes the drug Danvatirsen + Pembrolizumab unique for head and neck cancer?
The combination of Danvatirsen and Pembrolizumab is unique because it pairs an immune checkpoint inhibitor (Pembrolizumab) with another agent (Danvatirsen) to potentially enhance the immune response against head and neck cancer, offering a novel approach compared to traditional chemotherapy or single-agent immunotherapy.12345
What data supports the effectiveness of the drug Danvatirsen + Pembrolizumab for head and neck cancer?
Who Is on the Research Team?
Ezra Cohen, MD
Principal Investigator
Moores Cancer Center at UC San Diego Health
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive danvatirsen plus pembrolizumab or pembrolizumab alone in 21-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, with radiologic tumor assessments every 6 weeks and survival follow-up every 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Danvatirsen
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Flamingo Therapeutics NV
Lead Sponsor