Trials / Active Not Recruiting
Active Not RecruitingNCT06082167
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2/3, Randomized, Double-Blind, Controlled Study of Zanzalintinib (XL092) in Combination With Pembrolizumab vs Pembrolizumab in First-Line Treatment of Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Exelixis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed death-ligand 1 (PD-L1) positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanzalintinib | Specified doses on specified days |
| DRUG | Zanzalintinib-matched Placebo | Specified doses on specified days |
| BIOLOGICAL | Pembrolizumab | Specified doses on specified days |
Timeline
- Start date
- 2024-06-07
- Primary completion
- 2028-08-01
- Completion
- 2029-03-01
- First posted
- 2023-10-13
- Last updated
- 2025-08-17
Locations
168 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, Poland, Romania, Slovakia, South Korea, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06082167. Inclusion in this directory is not an endorsement.