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Monoclonal Antibodies

Palbociclib + Cetuximab for Head and Neck Cancer

Phase 3
Recruiting
Led By Douglas Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received no more than three lines of prior therapy for RM-HNSCC
Normal bone marrow and organ function criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 15 months)
Awards & highlights

Study Summary

This trial is testing if a combination of drugs improves overall survival for patients with head and neck squamous cell carcinoma who progressed after treatment with a PD-1/L1 inhibitor.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, issues from drug interactions if HIV positive or taking certain other medications, heart rhythm problems (QTc >500 msec), and complications from pre-existing conditions like uncontrolled illness or brain metastases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had up to three treatments for my head and neck cancer.
Select...
My bone marrow and organs are functioning normally.
Select...
My throat cancer is not related to HPV and has been confirmed by a lab test.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My cancer has a specific genetic change called CDKN2A loss-of-function.
Select...
My cancer has worsened despite treatment with a PD-1/L1 inhibitor.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 15 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 15 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Dose delivery as measured by percent of full doses given over time
Duration of response (DoR)
Frequency of adverse events
+2 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
96%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Cough
35%
Hyponatremia
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hypercalcemia
31%
Hyperkalemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Dysgeusia
20%
Hyperglycemia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Sinusitis
17%
Fever
17%
Peripheral sensory neuropathy
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Allergic rhinitis
11%
Hypernatremia
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Tooth infection
7%
Vertigo
7%
Non-cardiac chest pain
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cataract
6%
Knee pain
6%
Cellulitis
6%
Dehydration
6%
Death
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Dry eye
4%
Right arm numbness
4%
Nodule
4%
Watering eyes
4%
Edema trunk
4%
Flu-like symptoms
4%
Vaginal dryness
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Skin bump
4%
Head injury
4%
Memory impairment
4%
Back spasms
4%
Burn
4%
Abdominal pain
4%
Hypothyroidism
4%
Broken tooth
4%
Sinus pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Gait disturbance
2%
Peeling lips
2%
Paresthesia
2%
Vaginal itch
2%
Photophobia
2%
Facial nerve disorder
2%
Erythema right breast
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Radiation recall reaction (dermatologic)
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Respiratory syncytial virus (RSV)
2%
Erythema multiforme
2%
Peeling skin palms of hands
2%
Urinary retention
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Laryngeal inflammation
2%
Groin pain
2%
Bilateral nares sores
2%
Sepsis
2%
Yeast infection
2%
Sinus congestion
2%
Wrist pain
2%
Hyperuricemia
2%
Vaginal infection
2%
Rhinovirus
2%
Myocardial infarction
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Bladder infection
2%
Vaginal itching
2%
Wound infection
2%
Shoulder nodule
2%
Puncture wound
2%
Lung cancer
2%
Sinus tachycardia
2%
Intrascapular pain
2%
Leg pain
2%
Localized edema
2%
Hypermagnesemia
2%
Agitation
2%
Eye lid pain
2%
Blood bilirubin increased
2%
Fever blister
2%
Cold sweats
2%
Fungal toe infection
2%
COPD
2%
Diverticulitis
2%
Paronychia
2%
Activated partial thromboplastin time prolonged
2%
Fracture
2%
Urine discoloration
2%
Asthma
2%
Hoarseness
2%
Wrist fracture
2%
Hand cramps
2%
Red eye
2%
C. difficile
2%
Hemorrhoids
2%
Pharyngitis
2%
Left hand puncture wound
2%
Vaginal discharge
2%
Nail loss
2%
Oral fissure
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3710
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,888 Total Patients Enrolled
PfizerIndustry Sponsor
4,562 Previous Clinical Trials
10,906,895 Total Patients Enrolled
The Joseph Sanchez FoundationUNKNOWN

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04966481 — Phase 3
Head and Neck Squamous Cell Carcinoma Research Study Groups: Arm 1: Palbociclib + Cetuximab, Arm 2: Cetuximab
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04966481 — Phase 3
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04966481 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has been the most dangerous side effect linked to Palbociclib?

"This particular clinical trial for Palbociclib is Phase 3, meaning that there is already some data supporting its efficacy and multiple rounds of data supporting safety. Our team at Power rates it as a 3 on our safety scale."

Answered by AI

What other research studies have included Palbociclib in their testing?

"As of now, there are a total of 268 clinical trials underway for Palbociclib. Out of these ongoing studies, 46 are in Phase 3. The majority of the research being conducted is based out of Dresden and Arizona; however, 12294 other locations across the globe are also running similar trials."

Answered by AI

How many people are being given the opportunity to participate in this medical study?

"The clinical trial is currently enrolling 81 patients between 1 locations, according to the latest information on clinicaltrials.gov."

Answered by AI

How is Palbociclib typically employed in medical treatment?

"Palbociclib can help patients with hnscc, squamous cell carcinoma, and other conditions that have been determined by an FDA-approved test. Additionally, it is sometimes used in conjunction with radiation therapy."

Answered by AI

Are people still being recruited for participation in this research project?

"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov. The original posting was on April 6th, 2022 and there have been no changes since then."

Answered by AI

Has this sort of research been conducted before?

"As of today, there are 268 ongoing studies for Palbociclib in 61 countries and 1810 cities. The first clinical trial was sponsored by Bristol-Myers Squibb in 2005 and completed Phase 2 drug approval with the support of 154 participants. In the 15 years since then, 443 trials have been conducted."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~49 spots leftby Feb 2027