Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
← catalyst calendarNCT06082167 · readout ≤ 742 d
Sponsored by Exelixis (industry) · EXEL — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
600estimated
Sites
168
Countries
Argentina, Australia, Austria +23
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-06-07 | actual | When the study began enrolling |
| Primary completion | Aug 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Head and Neck Squamous Cell Carcinoma
Interventions
- Drug: Zanzalintinib — also filed as XL092
- Drug: Zanzalintinib-matched Placebo — also filed as XL092-matched Placebo
- Biological: Pembrolizumab — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFProgression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
measured Approximately 33 months after the first subject is randomized
Overall Survival (OS)
measured Approximately 50 months after the first subject is randomized
Publications
- PMID 40248950 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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