ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-07
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06082167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.
  2. * Should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization if given as part of multimodal treatment for locally advanced disease is allowed.
  3. * The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.
  4. * PD-L1 expression level Combined Positive Score (CPS) ≥ 1.
  5. * Participants with oropharyngeal cancer must have human papillomavirus (HPV) status from tumor tissue.
  6. * Measurable disease according to RECIST 1.1 as determined by the Investigator.
  7. * Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
  8. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  9. * Age 18 years (or the legal age of consent in your country, if higher than 18) or older on the day of consent.
  10. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  11. * Adequate organ and marrow function.
  1. * Nasopharynx, salivary gland or occult primary site (regardless of p16 status).
  2. * Has disease that is suitable for local therapy administered with curative intent.
  3. * Has received prior therapy with zanzalintinib, any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (for example, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
  4. * Life expectancy \< 3 months.
  5. * Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
  6. * Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
  7. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to randomization.
  8. * Positive hepatitis B surface antigen (HBsAg) test.
  9. * Positive hepatitis C virus (HCV) antibody test.
  10. * Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major or minor surgery must have occurred at least prior to randomization.
  11. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 28 days before randomization.
  12. * Pregnant or lactating females.
  13. * Administration of a live, attenuated vaccine within 30 days before randomization.

Contacts and Locations

Study Locations (Sites)

Exelixis Clinical Site #2
Fullerton, California, 92835
United States
Exelixis Clinical Site #1
Orange City, Florida, 32763
United States
Exelixis Clinical Site #163
Tampa, Florida, 33612-9497
United States
Exelixis Clinical Site #123
Athens, Georgia, 30607
United States
Exelixis Clinical Site #82
Atlanta, Georgia, 30322
United States
Exelixis Clinical Site #19
Chicago, Illinois, 60611
United States
Exelixis Clinical Site #62
Des Moines, Iowa, 50309
United States
Exelixis Clinical Site #100
Iowa City, Iowa, 52242
United States
Exelixis Clinical Site #4
Saint Louis, Missouri, 63110
United States
Exelixis Clinical Site #148
Lebanon, New Hampshire, 03756
United States
Exelixis Clinical Site #158
Camden, New Jersey, 08103
United States
Exelixis Clinical Site #3
Shirley, New York, 11967
United States
Exelixis Clinical Site #95
Durham, North Carolina, 27710
United States
Exelixis Clinical Site #117
Wilson, North Carolina, 27893
United States
Exelixis Clinical Site #43
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Exelixis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-06-07
Study Completion Date2029-03

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Squamous Cell Carcinoma