JOURNAL ONKOLOGIE – STUDIE

Paclitaxel Plus Cetuximab After First-line Checkpoint Inhibitor Failure

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04278092

Studienbeginn:
Februar 2020

Letztes Update:
16.03.2023

Wirkstoff:
Paclitaxel, Cetuximab

Indikation (Clinical Trials):
Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Medical University of Vienna

Collaborator:
-

Studienleiter

Thorsten Fuereder, MD
Principal Investigator
Medical University of Vienna

Kontakt

Christina Wagner
Kontakt:
Phone: +43140400
Phone (ext.): 72750
E-Mail: christina.wagner@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Thorsten Fuereder, MD
Phone: +4314040072750
E-Mail: thorsten.fuereder@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

Brief 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. 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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

- 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.

Studien-Rationale

Primary outcome:

1. Overall response rate (Time Frame - 3 months):
To evaluate the Overall Response Rate (CR/PR) rate according to RECIST V 1.1

Secondary outcome:

1. Median Overall Survival (Time Frame - 2 years):
The interval between start of treatment and death from any cause

2. Median Progression Free Survival (Time Frame - 2 years):
The interval between start of treatment and date of progression, or death, from any cause

3. Median Duration of response (Time Frame - 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 (Time Frame - 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 (Time Frame - 2 years)

6. Number of participants with adverse events (Time Frame - 2 years):
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.

Geprüfte Regime

Paclitaxel (Taxol):
Paclitaxel 175 mg/m2, q21
Cetuximab (Erbitux):
Cetuximab 400mg/m2 loading dose followed by weekly 250mg/m2

Quelle: ClinicalTrials.gov

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