← Back to Search

Other

Zanzalintinib + Pembrolizumab for Head and Neck Squamous Cell Carcinoma (STELLAR-305 Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Exelixis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have human papilloma virus (HPV) testing result for oropharyngeal cancer defined as p16 IHC testing.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 28 months after the first subject is randomized

Awards & highlights

STELLAR-305 Trial Summary

This trial is testing a new drug called zanzalintinib, in combination with pembrolizumab, in patients with advanced head and neck cancer. The goal is to see if this

Who is the study for?

Adults with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma, which is incurable by local therapy. They must not have had prior systemic therapy for this condition in the metastatic setting unless it was over 6 months ago as part of treatment for advanced disease. Eligible tumor locations include the oropharynx, oral cavity, hypopharynx, and larynx.Check my eligibility

What is being tested?

The trial compares Zanzalintinib combined with Pembrolizumab to a placebo paired with Pembrolizumab in patients who haven't tried systemic therapy yet. It's randomized and double-blind, meaning neither doctors nor participants know who gets the real drug versus placebo.See study design

What are the potential side effects?

Possible side effects may include immune-related reactions due to Pembrolizumab such as inflammation in organs like lungs or intestines, skin rash, liver issues; plus any potential unknown effects from Zanzalintinib since it's new.

STELLAR-305 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My throat cancer has been tested for HPV.

Select...

I am fully active or can carry out light work.

Select...

My head or neck cancer is confirmed and cannot be cured with surgery or radiation.

Select...

My cancer has a PD-L1 score of 1 or higher.

Select...

My cancer is in my throat, mouth, or voice box.

Select...

I am 18 years old or older.

STELLAR-305 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 28 months after the first subject is randomized

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 28 months after the first subject is randomized

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 28 months after the first subject is randomized for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)

Secondary outcome measures

Duration of Response (DOR) Per RECIST 1.1 by BIRC and Investigator

Objective Response Rate (ORR) per RECIST 1.1 by BIRC and Investigator

PFS per RECIST 1.1 by Investigator

STELLAR-305 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Zanzalintinib + PembrolizumabExperimental Treatment2 Interventions

Subjects with R/M HNSCC will receive zanzalintinib + pembrolizumab

Group II: Zanzalintinib-Matched Placebo + PembrolizumabPlacebo Group2 Interventions

Subjects with R/M HNSCC will receive zanzalintinib-matched placebo + pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor

117 Previous Clinical Trials

19,051 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being recruited for this research investigation?

"Indeed, as indicated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial took place on December 1st, 2023 and it was last edited on December 20th, 2023. The study aims to enroll a total of 500 individuals at a single designated site."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"Indeed, the data available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted on December 1st, 2023 and most recently updated on December 20th, 2023. A total of 500 individuals will be enrolled in this study across a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

2023. "Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082167.