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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

Must not have

Uncontrolled intercurrent illness

Rb (retinoblastoma) loss: mutation or homozygous deletion described on genomic sequencing report

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 15 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

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My bone marrow and organs are functioning normally.

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My throat cancer is not related to HPV and has been confirmed by a lab test.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My cancer has a specific genetic change called CDKN2A loss-of-function.

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My cancer has worsened despite treatment with a PD-1/L1 inhibitor.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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My cancer has a specific genetic change known as Rb loss.

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I have been treated with a CDK4/6 inhibitor for my head and neck cancer.

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I have had another type of cancer in the past year.

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I have been treated with cetuximab for cancer that came back or spread.

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My brain metastases have been treated and are not getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 15 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Secondary study objectives

Correlate CCND1 and PIK3CA alterations with efficacy endpoints

Duration of response (DoR)

Frequency of adverse events

+2 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

73%

Palmar-plantar erythrodysesthesia syndrome

58%

Fatigue

56%

Diarrhea

38%

Hypertension

38%

Nausea

30%

Mucositis

29%

Vomiting

26%

Weight loss

26%

Weight gain

24%

Anorexia

20%

Nail disorder

17%

Back pain

16%

Hypothermia

15%

Constipation

15%

Abdominal pain

14%

Neutrophil count decreased

13%

Dizziness

13%

Upper respiratory infection

13%

Headache

11%

Dyspepsia

10%

Pain in extremity

10%

Fever

10%

Obesity

10%

Dysgeusia

Arthralgia

Bone pain

Anemia

Cough

Pruritus

Flu like symptoms

Pain

Alopecia

Thromboembolic event

Bone fracture

Gastrointestinal infection

Spinal cord compression

Febrile neutropenia

Respiratory infection

Hot flashes

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3790

Cetuximab

2011