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Head and Neck Squamous Cell CarcinomaPhase 2NCT04278092

Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure

A Phase 2 study testing Paclitaxel and Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Immune checkpoint inhibitors (CPI) such as pembrolizumab or nivolumab have been recently approved for the treatment of recurrent/metastatic head and neck cancer (HNSCC). However, only a minority of patients respond to therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Paclitaxel and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteAustria
Study dates
10 Feb 2020to 31 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has provided written informed consent prior to any study-related procedure.
  • The patient is at least 18 years of age
  • Histologically proven locally advanced unresectable, recurrent and/or metastatic squamous cell carcinoma of the oropharynx, hypopharynx, larynx or oral cavity not amenable for salvage surgery
  • p16 status has to be determined for oropharyngeal carcinomas
  • Documented progressive disease based on investigator assessment according to RECIST 1.1, following receipt of a pembrolizumab based regimen given as first line therapy for R/M SCCHN
  • Measurable disease according to RECIST 1.1.
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  • The patient has a life expectancy of at least 3 months.
  • Has a performance status of ≤ 2 on the ECOG Performance Scale
  • Female patient of childbearing potential should have a negative urine or serum pregnancy prior to study . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study until 120 days after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy until 120 days after the last dose of study therapy.
  • Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 14 days of treatment initiation.

Who cannot join

  • Prior taxane therapy is not allowed except as part of induction therapy for locally advanced disease (completed at least 6 months before study entry)
  • Prior cetuximab therapy is not allowed except as part of either induction therapy or in combination with radiotherapy treatment for locally advanced disease (completed at least 6 months before study entry)
  • Patients with nasopharyngeal carcinomas or salivary glands cancers
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency including a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis A/B or Hepatitis C
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  • Has had prior pembrolizumab within 2 weeks prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from (immune- related) adverse events other than endocrine side effects.
  • Has had prior chemotherapy or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., recovery to ≤ Grade 1 or baseline grade prior to pembrolizumab) from adverse events due to a previously administered agent.
  • Has had chemotherapy, targeted therapy or investigational drugs after checkpoint inhibitor failure for second line therapy .
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit until 120 days after the last dose of trial treatment.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna

    Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Official title: Paclitaxel Plus Cetuximab for the Treatment of Recurrent and/or Metastatic Head and Neck Cancer After First-line Checkpoint Inhibitor Failure: A Multicenter, Single Arm Study

Immune checkpoint inhibitors (CPI) such as pembrolizumab or nivolumab have been recently approved for the treatment of recurrent/metastatic head and neck cancer (HNSCC). However, only a minority of patients respond to therapy. From the clinical point of view the optimal management of patients progressing on or after CPI therapy is still a challenge. Retrospective analysis showed that HNSCC patients, who progressed on/after CPI, demonstrated an overall response rate (ORR) of up to 30% subsequent to chemotherapy +/- cetuximab treatment. It is the aim of this study to evaluate if paclitaxel plus cetuximab after first line pembrolizumab failure is an effective salvage therapy in 50 R/M HNSCC patients. The primary endpoint is ORR according to RECIST V 1.1.

Being tested
Paclitaxel, Cetuximab
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 175 mg/m2, q21

  • CetuximabDrug

    Also called Erbitux

    Cetuximab 400mg/m2 loading dose followed by weekly 250mg/m2

Study groups in NCT04278092
Study groupRoleWhat they receive
Paclitaxel plus CetuximabExperimentalPaclitaxel combination with weekly cetuximab will be administered for up to six cycles. Thereafter weekly cetuximab maintenance will be given.
Receives: Drug: Paclitaxel; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    To evaluate the Overall Response Rate (CR/PR) rate according to RECIST V 1.1

    Measured: 3 months

Secondary outcomes (6)

  1. Median Overall Survival

    The interval between start of treatment and death from any cause

    Measured: 2 years

  2. Median Progression Free Survival

    The interval between start of treatment and date of progression, or death, from any cause

    Measured: 2 years

  3. Median Duration of response

    Measured: 2 years

  4. Health-related quality-of-life scores per patient measured according to the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C-30 scoring manual

    Measured: 2 years

  5. Health-related quality-of-life scores per patient measured according to the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) H&N35 scoring manual

    Measured: 2 years

  6. Number of participants with adverse events

    AEs, treatment-related AEs, serious adverse events (SAEs), and treatment-related SAEs will be tabulated using worst grade per NCI CTCAE v 5.0 criteria.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start10 Feb 2020
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278092
Sponsor's protocol ID
PACE ACE
Status last verified
May 2025
First submitted
18 Feb 2020
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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