NCT06912087 Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
| NCT ID | NCT06912087 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Chicago |
| Condition | Head and Neck Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2027-06-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2025-09-29 with a primary completion date of 2027-06-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), which is considered incurable by local therapies. * Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible. * Age: Participants must be at least 18 years old. * ECOG Performance Status: Must be 0-1. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing. * Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R/M disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments. * Adequate organ and marrow function, including: * Absolute neutrophil count (ANC) ≥ 1500/mm3. * Platelets ≥ 100,000/mm3. * Hemoglobin ≥ 9 g/dL. * Normal liver and kidney function. * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document. * Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab. Exclusion Criteria: * Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors. * More than two prior lines of systemic therapy in the recurrent/metastatic setting. * Relapsed disease within 3 months of definitive therapy. * Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment). * Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks. * Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants. * Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation. * Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders. * Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening. * Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).
Contact & Investigator
Ari Rosenberg, MD
PRINCIPAL INVESTIGATOR
University of Chicago Medicine Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06912087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06912087 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06912087 currently recruiting?
Yes, NCT06912087 is actively recruiting participants. Contact the research team at cancerclinicaltrials@bsd.uchicago.edu for enrollment information.
Where is the NCT06912087 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06912087 clinical trial?
NCT06912087 is sponsored by University of Chicago. The principal investigator is Ari Rosenberg, MD at University of Chicago Medicine Comprehensive Cancer Center. The trial plans to enroll 36 participants.