STELLAR 305

Actively Recruiting

Phase 2/3 Randomized, Double-Blind Study of Zanzalintinib (XL092) With Pembrolizumab vs Pembrolizumab in 1L PD-L1 Positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

THE COMBINATION OF ZANZALINTINIB AND PEMBROLIZUMAB IS NOT APPROVED FOR THE USE UNDER INVESTIGATION IN THIS TRIAL. SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED.

Study Overview
Key Eligibility Criteria
Key Endpoints
Participating Sites

Study Overview

Approximately 250 eligible patients with PD-L1 positive, R/M HNSCC will be randomly assigned to zanzalintinib in combination with pembrolizumab or pembrolizumab alone to evaluate the activity of the combination therapy on PFS by BIRC and OS vs pembrolizumab monotherapy. If phase 2 results support study continuation to phase 3, an additional 250 patients will be randomized for a total of 500 patients.

Chart explaining phase 3, randomized, open-label study of zanzalintinib with atezolizumab vs regorafenib in patients with MSS/MSI-low mCRC

Key Eligibility Criteria

R/M HNSCC of the oropharynx, oral cavity, hypopharynx, and larynx incurable by local therapy; nasopharynx not allowed
Measurable disease
No prior systemic therapy for R/M HNSCC
- Systemic therapy given as part of multimodal treatment for locally advanced disease allowed if completed >6 months prior to randomization
PD-L1 CPS ≥1
No prior therapy with any anti–PD-1/PD-L1/PD-L2 agent, or an agent directed to another stimulatory or co-inhibitory T-cell receptor
No prior treatment with zanzalintinib

Key Endpoints

Multiple Primary Endpoints

PFS by BIRC
OS

Secondary Endpoints

PFS by investigator
ORR and DOR by BIRC and investigator
Safety and tolerability

Exploratory Endpoint

HRQoL by EORTC QLQ-C30/QLQ-H&N35 and EQ-5D-5L

1L, first-line; BIRC, blinded independent radiology committee; CPS, combined positive score; DOR, duration of response; EORTC, European Organisation for Research and Treatment of Cancer; EQ-5D-5L, EuroQoL five-dimension, five-level health questionnaire instrument; HNSCC, head and neck squamous cell carcinoma; HRQoL, health-related quality of life; IV, intravenous; ORR, objective response rate; OS, overall survival; PD-1, programmed death receptor-1; PD-L1, programmed death receptor-1 ligand; PD-L2, programmed death receptor-2 ligand; PFS, progression-free survival; q3w, once every 3 weeks; qd, once daily; QLQ-C30, Quality of Life Questionnaire–Core 30; QLQ-H&N35, Quality of Life Questionnaire–Head & Neck 35; R, randomization; R/M, recurrent or metastatic.

Participating Sites

STELLAR-305 will be conducted in North America, South America, Europe, and Asia Pacific. Call 1-888-393-5494 (toll-free) or 1-303-389-1847 for specific location and site information and to confirm whether sites near you are still enrolling new patients.

Currently open or planned clinical site cities:

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

To learn more about this trial, go to clinicaltrials.gov and search for NCT06082167, or contact Exelixis Medical Information at 1-888-393-5494 (toll-free),
1-303-389-1847, or medinfo@exelixis.com.