Exelixis XL092-305
Research type
Research Study
Full title
A Phase 2/3, Randomized, Double-blind, Controlled Study of Zanzalintinib (XL092) in Combination with Pembrolizumab vs Pembrolizumab in the First-line Treatment of Subjects with PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
IRAS ID
1009269
Contact name
Martin Giblin
Contact email
Sponsor organisation
Exelixis Inc.
Research summary
This is a double-blind study, which means that neither patient nor study doctor will know which of the two study treatment groups they will be assigned to. Additionally, they will not find out which study treatment group they are assigned to if your cancer worsens or they have a side effect requiring them to discontinue participation. This could potentially impact treatment options following study participation. Their study doctor can find out the study drug they are receiving only if it is critical to emergency management. • Group 1: - -Pembrolizumab (200 mg) given by a needle into a vein in the arm (also called an intravenous (IV) infusion) every 3 weeks with a zanzalintinib (100 mg) tablet once daily by mouth.
• Group 2: Pembrolizumab (200 mg) given by IV infusion every 3 weeks with a placebo tablet (a pill that looks like the active drug but contains no medication) once daily by mouth.
They have an equal chance of being assigned to either study treatment group. This means that they will have a 50% chance of receiving zanzalintinib with pembrolizumab and a 50% chance of receiving pembrolizumab with placebo.
About 500 people (250 in each study treatment group) are expected to take part in this study.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0028
Date of REC Opinion
26 Mar 2024
REC opinion
Further Information Favourable Opinion