Status:
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
Lead Sponsor:
Exelixis
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy.
- 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.
- The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, and larynx.
- PD-L1 expression level Combined Positive Score (CPS) ≥ 1.
- Participants with oropharyngeal cancer must have human papillomavirus (HPV) status from tumor tissue.
- Measurable disease according to RECIST 1.1 as determined by the Investigator.
- Tumor samples (archival or fresh tumor biopsy) are required. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
- 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.
- Age 18 years (or the legal age of consent in your country, if higher than 18) or older on the day of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ and marrow function.
Exclusion
- Nasopharynx, salivary gland or occult primary site (regardless of p16 status).
- Has disease that is suitable for local therapy administered with curative intent.
- 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).
- Life expectancy \< 3 months.
- Had progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior to randomization.
- 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.
- Positive hepatitis B surface antigen (HBsAg) test.
- Positive hepatitis C virus (HCV) antibody test.
- 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.
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG) within 28 days before randomization.
- Pregnant or lactating females.
- Administration of a live, attenuated vaccine within 30 days before randomization.
Key Trial Info
Start Date :
June 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06082167
Start Date
June 7 2024
End Date
March 1 2029
Last Update
August 17 2025
Active Locations (168)
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1
Exelixis Clinical Site #2
Fullerton, California, United States, 92835
2
Exelixis Clinical Site #1
Orange City, Florida, United States, 32763
3
Exelixis Clinical Site #163
Tampa, Florida, United States, 33612-9497
4
Exelixis Clinical Site #123
Athens, Georgia, United States, 30607