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Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Testing safety of Danvatirsen and Pembrolizumab for head and neck cancer.

Recruiting
18 years and older
All
Phase 2

This study tests two medicines, **danvatirsen** and **pembrolizumab**, for treating a type of cancer called recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). In simple terms, this is a head and neck cancer that has come back or spread to other parts of the body. Pembrolizumab is a medicine that helps the immune system fight cancer, while danvatirsen is being studied to see if it helps pembrolizumab work better. Participants will be divided into two groups: two-thirds will get both medicines, and one-third will get pembrolizumab alone.

The study requires a biopsy, which is a sample of the tumor, before starting. Treatment happens in cycles of 21 days and can last up to 24 months. Patients will have their tumors checked with scans every 6 weeks. If the treatment stops for any reason, there will be follow-ups for safety and survival for up to 15 months.

  • Study duration can be up to 2 years with regular check-ups.
  • A tumor sample is required before joining the study.
  • Participants may receive a combination of two medicines or one, based on random assignment.
Study details
    HNSCC

NCT05814666

Flamingo Therapeutics NV

6 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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