Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
Research type
Research Study
Full title
An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
IRAS ID
1009267
Contact name
Susan Macintyre
Contact email
Sponsor organisation
Flamingo Therapeutics
Clinicaltrials.gov Identifier
Research summary
Head and neck cancer is the sixth most common cancer worldwide. Despite the strong medications available for patients when they are first treated, a significant percentage of patients will have a relapse of their head and neck cancer or it will spread to other parts of their body known as metastasis . Keytruda© is a therapy approved for the treatment of head and neck cancer that has relapsed or metastasised. This study will evaluate if the combination of Keytruda with an investigational agent, danvatirsen, will be a more effective treatment than Keytruda alone.
Persons who are 18 years of age or older with relapsed or metastasised head and neck cancer who want to participate in the study, will have a series of evaluations to determine if they are eligible to enroll and receive medication. Persons who are eligible to enroll in the study, will be randomly assigned to receive either danvatirsen + Keytruda or Keytruda alone. Participants who receive the investigational drug, will have an intravenous (IV) infusion of danvatirsen followed by an IV infusion of pembrolizumab every week. Participants receiving Keytruda alone will have an IV infusion of Keytruda every 3 weeks. All participants will continue study medication until the medication is no longer effective or they have intolerable side effects or they reach the maximum amount allowed. During treatment a participant will have assessments regularly performed such as physical exams, blood levels, scans of their tumors and other procedures. After a participant discontinues from the medication, they continue to have visits and contact with their study doctor to monitor their health.
This study is being funded by Flamingo Therapeutics and will be conducted at multiple location globally. This study will be overseen by a safety review committee to ensure the safety of study participants.
REC name
London - Fulham Research Ethics Committee
REC reference
24/LO/0144
Date of REC Opinion
9 Apr 2024
REC opinion
Further Information Favourable Opinion