Palbociclib + Cetuximab for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Washington University School of Medicine
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain HIV medications may need to be avoided due to potential drug interactions. It's best to discuss your current medications with the trial team.
Is the combination of Palbociclib and Cetuximab safe for humans?
Cetuximab is generally considered safe and well-tolerated, with common side effects being mild skin issues. It has been used safely in treatments for colorectal and head and neck cancers.
12345What makes the drug combination of Palbociclib and Cetuximab unique for head and neck cancer?
The combination of Palbociclib and Cetuximab is unique because it targets the epidermal growth factor receptor (EGFR) with Cetuximab, a monoclonal antibody, while Palbociclib, a CDK4/6 inhibitor, may help control cell division, offering a novel approach compared to traditional chemotherapy or radiotherapy alone.
36789Eligibility Criteria
This trial is for adults with CDKN2A-altered, HPV-unrelated head and neck squamous cell carcinoma who have had disease progression after treatment with a PD-1/L1 inhibitor. They should not have received more than three prior therapies, must be in good physical condition (ECOG ≤ 1), and have proper organ function. Pregnant women are excluded, and participants must agree to use contraception.Inclusion Criteria
I have had up to three treatments for my head and neck cancer.
My bone marrow and organs are functioning normally.
My throat cancer is not related to HPV and has been confirmed by a lab test.
I am fully active and can carry on all my pre-disease activities without restriction.
My cancer has a specific genetic change called CDKN2A loss-of-function.
My cancer has worsened despite treatment with a PD-1/L1 inhibitor.
I am 18 years old or older.
Exclusion Criteria
I do not have any unmanaged ongoing illnesses.
My cancer has a specific genetic change known as Rb loss.
I have been treated with a CDK4/6 inhibitor for my head and neck cancer.
I have had another type of cancer in the past year.
I have been treated with cetuximab for cancer that came back or spread.
My brain metastases have been treated and are not getting worse.
Participant Groups
The study compares the effectiveness of combining Palbociclib with Cetuximab versus using Cetuximab alone in improving overall survival rates. Participants will be randomly assigned to one of these two treatments after showing progression on a PD-1/L1 inhibitor.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Palbociclib + CetuximabExperimental Treatment2 Interventions
* Palbociclib by mouth 125 mg/daily on Days 1-21 of each 28 day cycle
* Cetuximab: Initial dose 400mg/m\^2 intravenous (IV); Subsequent doses 250 mg/m\^2 IV, weekly
Group II: Arm 2: CetuximabActive Control1 Intervention
-Cetuximab: Initial dose 400mg/m\^2 intravenous (IV); Subsequent doses 250 mg/m\^2 IV, weekly
Cetuximab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Erbitux for:
- Locally or regionally advanced squamous cell carcinoma of the head and neck
- Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
- BRAF V600E mutation-positive metastatic colorectal cancer
🇪🇺 Approved in European Union as Erbitux for:
- Squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Saint Luke's HospitalKansas City, MO
Washington University School of MedicineSaint Louis, MO
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
PfizerIndustry Sponsor
The Joseph Sanchez FoundationCollaborator
References
A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer. [2022]Cetuximab (Erbitux(®)) was approved for the treatment of metastatic colorectal cancer in Japan in 2008. To verify information on the safety in practical use of cetuximab, we conducted post-marketing surveillance in accordance with the conditions for approval.
Cetuximab. [2020]Cetuximab (Erbitux; ImClone Systems/Bristol-Myers Squibb) is a monoclonal antibody that binds to the epidermal growth factor receptor, which is important in the growth of many cancers. In February 2004, it was granted accelerated approval by the US FDA for the treatment of metastatic colorectal cancer on the basis of tumour response rates in Phase II trials.
Investigational EGFR-targeted therapy in head and neck squamous cell carcinoma. [2021]EGFR is an established therapeutic target in head and neck squamous cell carcinoma (HNSCC). The EGFR-targeting monoclonal antibody cetuximab (Erbitux, Imclone Systems, Inc., Branchburg, USA) was FDA-approved for use in HNSCC in 2006. The molecular basis for the efficacy of an antibody approach compared with inhibition of EGFR tyrosine kinase function using small-molecule inhibitors, or downregulation of protein expression via antisense strategies, remains incompletely understood.
Complications after oesophagectomy with possible contribution of neoadjuvant therapy including an EGFR-antibody to a fatal outcome. [2021]Different molecular therapies like the EGFR-inhibiting antibody cetuximab have come into clinical practice. Cetuximab is EMEA-approved for metastatic colorectal cancer and advanced squamous-cell head and neck cancer. Administration is said to be safe and well tolerated with common, usually mild dermatologic side effects.
[The efficacy of cetuximab for metastatic colorectal cancer]. [2018]Cetuximab (Erbitux) is a targeted therapy that used to treat metastatic colorectal cancer. It is classified as a "monoclonal antibody" and "signal transduction inhibitor" by binding to epidermal growth factor receptors (EGFR). We report 6 patients who responded well to cetuximab out of 8 patients with recurrent/advanced colorectal cancer who have received the drug at our hospital since November 2008. Four patients were men and 2 were women, with their ages ranging from 48 to 77 years. The primary cancers were located in the rectum (n=1), sigmoid colon (n=4), and ascending colon (n=1). Performance status (PS) was 0-1. These patients were treated with cetuximab as second-line (n=1), third-line (n=3), fifth-line (n=1), or seventh-line (n=1) therapy. Three patients received cetuximab monotherapy, while the other 3 were given CPT-11 (150 mg/m2, every 2 weeks) as concomitant therapy. Among the 3 patients receiving combination therapy, 2 patients had already received treatment with FOLFIRI. Even in the cetuximab monotherapy group, a partial response (PR) was observed in 2 patients, demonstrating a strong cytoreductive effect. Tumor markers also showed large decreases, with the percent decrease at 1 month being 31.7% and 60.8% in the monotherapy and combination therapy groups, respectively, while it was respectively 14.1% and 29.5% at 2 months. The mean progression-free survival (PFS) time and the time to treatment failure (TTF) were respectively 3.0 months and 4.5 months in the monotherapy group versus 7.3 months and 9.3 months in the combination therapy group. Acneiform rash and paronychia occurred in all 6 patients.
[Monoclonal antibodies for the treatment of head and neck cancer]. [2018]Monoclonal antibodies are now part of the armamentarium available for the treatment of head and neck cancer. Cétuximab, a monoclonal antibody targeting EGFR, improves overall survival as compared with radiotherapy alone as radical treatment of locally advanced head and neck cancer. It is now reimbursed in Belgium after multidisciplinary discussion if cisplatin is contra-indicated. In the metastatic setting adding cétuximab to platinum based chemotherapy improves overall survival as compared with chemotherapy alone, a first-time event over a 30-year period, unfortunately not yet accessible to the Belgian patients. Other monoclonal antibodies targeting EGFR or VEGF are also currently under investigation while cétuximab is being explored in the induction, the maintenance or the post-operative radiotherapy settings.
Cetuximab, paclitaxel, carboplatin, and radiation for head and neck cancer: a toxicity analysis. [2015]To determine the feasibility and toxicity of the addition of cetuximab to paclitaxel, carboplatin, and concurrent radiation for patients with head and neck cancer.
Evaluation of Cetuximab in combination with radiotherapy or chemotherapy against advanced squamous cell carcinoma of the head and neck. [2019]Cetuximab is an epidermal growth factor receptor inhibitor which has been recently focused on the therapy of squamous cell carcinoma of the head and neck based on the nearly universal expression of this protein, the negative prognostic associations with expression and robust preclinical data. Clinical trials to date have demonstrated modest activity of this drug in combination with chemotherapy or radiotherapy against advanced squamous cell carcinoma of the head and neck. This article reviews the progress in utilization of cetuximab in advanced squamous cell carcinoma of the head and neck. Supported by Shanghai Leading Academic Discipline Project (Y0203).
Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer. [2022]We incorporated cetuximab, a chimeric monoclonal antibody against the epidermal growth factor receptor (EGFR), into the induction therapy and subsequent chemoradiotherapy of head and neck cancer (HNC).