Phase 3: testing Palbociclib for HPV-unrelated Head and Neck Squamous Cell Carcinoma
This multicenter, open-label, randomly assigned phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab this drug alone (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 this drug alone or in combination with other therapy).
Official registry: https://clinicaltrials.gov/study/NCT04966481 · Washington University School of Medicine · enrollment listed as 81
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Palbociclib, or Cetuximab. The registry lists allocation as randomized. This multicenter, open-label, randomly assigned phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab this drug alone (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 this drug alone or in combination with other therapy).
They plan to enroll about 81 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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: A Multicenter, Open-Label, Randomized Phase 3 Trial
Interventions: Palbociclib, Cetuximab
Primary outcome (registry wording): Overall survival (OS)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Histologically or cytologically confirmed RM-HNSCC that is HPV-unrelated disease; defined as SCC of the oral cavity, larynx, or hypopharynx and p16 negative SCC of the oropharynx or p16 negative non-cutaneous SCC unknown primary of the neck
- CDKN2A loss-of-function (LOF) alteration: mutation or homozygous deletion described on genomic sequencing report
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam, per RECIST 1.1
- Disease progression on a PD-1/L1 inhibitor-containing regimen (given as this drug alone or in combination with other therapy)
- Received no more than three lines of prior therapy for RM-HNSCC
- At least 18 years of age
- how well you can do daily activities (ECOG score) ≤ 1
Who the registry excludes
- Prior treatment with cetuximab for recurrent or metastatic disease (however, prior cetuximab given as a component of multimodality therapy for newly diagnosed, locally advanced, non-metastatic HNSCC is allowable)
- Prior treatment with a CDK4/6 inhibitor for RM-HNSCC
- Rb (retinoblastoma) loss: mutation or homozygous deletion described on genomic sequencing report
- Currently receiving any other investigational agents
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 1 year before registration and the patient has no evidence of recurrent/persistent disease
- Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study (excluding cetuximab)
Public study contact (from the registry)
Douglas Adkins, M.D.
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
5 listed- Sanford Worthington Medical Center — Worthington, Minnesota (not_yet_recruiting)
- Saint Luke's Hospital — Kansas City, Missouri (withdrawn)
- Washington University School of Medicine — St Louis, Missouri (recruiting)
- Sanford Roger Maris Cancer Center — Fargo, North Dakota (recruiting)
- Sanford Medical Center — Sioux Falls, South Dakota (recruiting)
FAQ about this NCT record
Is NCT04966481 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04966481?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04966481?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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