Stellar 305

Actively Recruiting

Phase 2/3 Randomized, Double-Blind Study of Zanzalintinib (XL092) With Pembrolizumab vs Pembrolizumab in 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

  • Resources for HCPs

Study Overview

Rationale

Current treatment options for patients with head and neck squamous cell carcinoma (HNSCC) recommend surgery, chemoradiation, chemotherapy, and immunotherapy (including pembrolizumab and nivolumab).1,2 Furthermore, advances in the understanding of disease biology have allowed for the development of combination therapies.3 Exelixis is evaluating zanzalintinib in combination with pembrolizumab in patients with HNSCC (excluding those with nasopharynx tumors) who have not received prior ICI therapy.

Design

Approximately 250 eligible patients from ~200 sites globally (North America, South America, Europe, and Asia Pacific) will be enrolled in phase 2 of the STELLAR-305 study. Patients with PD-L1 positive, recurrent or metastatic HNSCC incurable by local therapies will be randomly assigned in a 1:1 ratio to zanzalintinib in combination with pembrolizumab or to pembrolizumab alone to evaluate the effect of the combination therapy on PFS and OS vs pembrolizumab. If phase 2 results support study continuation to phase 3, an additional 250 patients will be randomized in a 1:1 ratio for a total of 500 patients.

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

Participating Sites

STELLAR-305 will be conducted in North America, South America, Europe, and Asia Pacific.

Currently open clinical sites:

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

Resources for Healthcare Professionals

Here you can find further information on STELLAR-305. To view information for a specific language, select it from the dropdown below.

STELLAR 305 trial infographic summary for healthcare professionals

Trial Infographic Summary

A quick snapshot of the trial

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STELLAR 305 trial healthcare professional brochure

Healthcare Professional Brochure

Find out more details about the trial

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STELLAR 305 trial brochure for patients

Patient-friendly Brochure

Use to discuss with patients who wish to enroll

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References

  1. Pfister DG, et al. Head and Neck Cancers, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020;18(7):873-898.
  2. Machiels J-P, et al. Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS–ESMO–ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31:1462-1475.
  3. Saba NF, et al. Pembrolizumab and cabozantinib in recurrent metastatic head and neck squamous cell carcinoma: a phase 2 trial. Nat Med. 2023;29:880-887.

BIRC, blinded independent radiology committee; CPS, combined positive score; DOR, duration of response; EORTC QLQ-C30/QLQ-H&N35, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire—Core 30/Head and Neck 35; EQ-5D-5L, EuroQoL five-dimension, five-level health questionnaire instrument; HNSCC, head and neck squamous cell carcinoma; HRQoL, health-related quality of life; ICI, immune checkpoint inhibitor; 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; R, randomization; R/M, recurrent or metastatic.

To learn more about this trial, go to clinicaltrials.gov and search for NCT06082167, or contact Exelixis Medical Information at medinfo@exelixis.com.

Links to Exelixis Website

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