Actively Recruiting
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
Led by Washington University School of Medicine · Updated on 2026-04-20
81
Participants Needed
5
Research Sites
307 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).
CONDITIONS
Official Title
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed recurrent or metastatic HPV-unrelated head and neck squamous cell carcinoma including SCC of the oral cavity, larynx, hypopharynx, and p16 negative SCC of the oropharynx or non-cutaneous SCC unknown primary of the neck
- CDKN2A loss-of-function alteration (mutation or homozygous deletion) confirmed by genomic sequencing
- Measurable disease with lesions �3 10 mm by CT scan, �3 20 mm by chest x-ray, or �3 10 mm by clinical exam per RECIST 1.1
- Disease progression on a PD-1/L1 inhibitor-containing regimen
- Received no more than three prior therapies for recurrent or metastatic disease
- At least 18 years old
- ECOG performance status of 0 or 1
- Normal bone marrow and organ function including hemoglobin �3 8 g/L, neutrophils �3 1,000/mcL, platelets �3 100,000/mcL, bilirubin �4 3x institutional upper limit, AST/ALT �4 5x institutional upper limit (or �4 10x if liver metastases), creatinine �3x institutional upper limit or creatinine clearance �30 mL/min
- Agreement to use adequate contraception during and after the study if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with cetuximab for recurrent or metastatic disease (except prior use in multimodality therapy for newly diagnosed, non-metastatic disease)
- Prior treatment with a CDK4/6 inhibitor for recurrent or metastatic disease
- Retinoblastoma (Rb) loss confirmed by genomic sequencing
- Currently receiving other investigational agents
- History of other malignancy unless treatment completed at least 1 year prior with no recurrence
- Untreated or progressing brain metastases; treated brain metastases allowed if stable for at least 4 weeks
- Allergic reactions to palbociclib or similar agents (excluding cetuximab)
- Prior grade 3 or 4 hypersensitivity to cetuximab
- Uncontrolled serious illness including active infection, heart failure, unstable angina, or arrhythmia
- QTc interval over 500 msec
- HIV infection with CD4+ count below 350 cells/mcL or recent AIDS-defining infection; recommended exclusion of certain ART drugs due to interactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sanford Worthington Medical Center
Worthington, Minnesota, United States, 56187
Not Yet Recruiting
2
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
5
Sanford Medical Center
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
Research Team
D
Douglas Adkins, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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