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Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
EU CTIS ID: 2023-506308-24-00
What this study is testing
To compare the efficacy of zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in subjects with recurrent or metastatic head and neck squamous cell carcinoma
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy Note: Subjects 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. Note: The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- PD-L1 expression level Combined Positive Score (CPS) ≥ 1
- Subjects with oropharynx cancer must have assessment of HPV status from tumor tissue, per p16 testing.
- Measurable disease according to RECIST 1.1 determined by the Investigator.
- Recovery to baseline or ≤ Grade 1 severity(CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) is 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.
You likely can't join if
- Nasopharynx, salivary gland or occult primary site (regardless of p16 status)
- 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.
- Has disease that is suitable for local therapy administered with curative intent
See the full eligibility criteria
Who can join
- Histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapy Note: Subjects 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. Note: The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- PD-L1 expression level Combined Positive Score (CPS) ≥ 1
- Subjects with oropharynx cancer must have assessment of HPV status from tumor tissue, per p16 testing.
- Measurable disease according to RECIST 1.1 determined by the Investigator.
- Recovery to baseline or ≤ Grade 1 severity(CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) is 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 ; with documented assessment of independent activities of daily living (ADLs) and physical activity, as appropriate and according to subject’s age.
- Adequate organ and marrow function
What rules you out
- Nasopharynx, salivary gland or occult primary site (regardless of p16 status)
- 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.
- Has disease that is suitable for local therapy administered with curative intent
- Has received prior systemic immunotherapy 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 (eg, CTLA-4, OX- 40, CD137), except for anti-PD-1 or anti-PD-L1 agents in the peri-operative setting if progression/recurrence occurred ≥12 months after its completion.
- Life expectancy < 3 months and/or a rapidly progressing disease (eg, uncontrolled tumor pain), which should be reviewed in the context of prior systemic therapy in the curative setting and must be discussed with the Sponsor.
- Had documented progressive disease within less than 6 months of completion of either curatively or palliatively intended systemic treatment (ie, chemotherapy) for HNSCC, in locally advanced HNSCC or peri-operative setting. Note: radiographic confirmation of progressive disease is required. If both histologic and radiographic confirmations are available, the earliest date should be considered for documentation purposes. Subjects who progressed within 6 months of systemic treatment in non-curative setting are also excluded.
- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks prior randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy, such as radiation pneumonitis or fistulation, are not eligible
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Argentina
- Thailand
- Australia
- Chile
- Israel
- Colombia
- Malaysia
- United States
- United Kingdom
- Taiwan
- Brazil
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Argentina; Thailand; Australia; Chile; Israel and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.