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Compares treatment options for HPV-unrelated Head and Neck Squamous Cell Carcinoma
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
ClinicalTrials.gov ID: NCT04966481
What this study is testing
What is Palbociclib?
Palbociclib is an investigational medicine, being studied as a potential treatment for hpv-unrelated head and neck squamous cell carcinoma.
Also referred to as Ibrance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed RM-HNSCC that is HPV-unrelated disease; defined as SCC of the oral cavity, larynx, or hypopharynx and p16...
- 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...
- Disease progression on a PD-1/L1 inhibitor-containing regimen (given as monotherapy or in combination with other therapy).
- Received no more than three lines of prior therapy for RM-HNSCC.
You likely can't join if
- Prior treatment with cetuximab for recurrent or metastatic disease (however, prior cetuximab given as a component of multimodality therapy for newly...
- 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...
- Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as...
See the full eligibility criteria
- 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...
- 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...
- Disease progression on a PD-1/L1 inhibitor-containing regimen (given as monotherapy or in combination with other therapy).
- Received no more than three lines of prior therapy for RM-HNSCC.
- At least 18 years of age.
- ECOG performance status ≤ 1.
- Normal bone marrow and organ function as defined below:
- Hemoglobin ≥ 8 g/L
- Absolute neutrophil count ≥ 1,000/mcl
- Platelets ≥ 100,000/mcl
- Total bilirubin ≤ 3 x institutional upper limit of normal (IULN)
- AST(SGOT)/ALT(SGPT) ≤ 5 x IULN (for cases involving liver metastases, AST/ALT ≤ 10 x IULN)
- Serum creatinine \ 30 mL/min by Cockcroft-Gault
- The effects of palbociclib and cetuximab on the developing human fetus are unknown. For this reason and because CDK 4/6 inhibitors are known to be teratogenic, women of childbearing potential and men must agree to use...
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- 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)...
- 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).
- Prior grade 3 or 4 (per CTCAE 5.0) hypersensitivity reaction to cetuximab.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- QTc \>500 msec (using Bazette formula).
- Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with...
The study team makes the final eligibility decision.
Where it's taking place
- Worthington, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Fargo, North Dakota, United States
- Sioux Falls, South Dakota, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Worthington, Minnesota, United States; Kansas City, Missouri, United States; St Louis, Missouri, United States; Fargo, North Dakota, United States; Sioux Falls, South Dakota, United States. 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 ClinicalTrials.gov; the study team decides eligibility.