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NCT05814666RECRUITINGIRB Ready

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

(PEMDA-HN)

Sponsored by Flamingo Therapeutics NV

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 81 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Must have given written informed consent (signed and dated). 2. Aged โ‰ฅ18 years at the time of informed consent. 3. 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. 4. Presence of measurable tumor per RECIST v1.1 criteria. 5. Detectable PD-L1 expression in tumor, defined as CPS โ‰ฅ1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test. 6. Baseline fresh tumor biopsy or archival specimen. 7. ECOG performance status of 0 or 1. 8. Adequate organ function within 10 days of study treatment, 9. Oxygen saturation on room air โ‰ฅ92% by pulse oximetry. 10. Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control. 11. Males must be surgically sterile or agree to adequate birth contr

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

81 participants

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Gender

ALL

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Sponsor

Flamingo Therapeutics NV

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Torrance

California

Location available
View Torrance location page
RECRUITING

Westwood, Los Angeles

California

Location available
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Merriam

Kansas

Location available
View Merriam location page

๐Ÿ“ And 12 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Head and Neck Cancer Treatment in Tucson?

Join others in Arizona exploring innovative treatment options through clinical research

Head and Neck Cancer Treatment Options in Tucson, Arizona

If you're searching for Head and Neck Cancer treatment in Tucson, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tucson, Irvine, Torrance and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Head and Neck Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 81 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Head and Neck Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Head and Neck Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Head and Neck Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05814666. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.