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JOURNAL ONKOLOGIE – STUDIE

Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT03480672

Studienbeginn:
August 2018

Letztes Update:
04.12.2020

Wirkstoff:
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University of Leipzig

Collaborator:
-

Studienleiter

Andreas Dietz, Prof. Dr.
Principal Investigator
University Leipzig

Kontakt

Andreas Dietz, Prof. Dr.
Kontakt:
Phone: 0049 34197
Phone (ext.): 21700
E-Mail: andreas.dietz@medizin.uni-leipzig.de
» Kontaktdaten anzeigen
Anett Schmiedeknecht, Dr.
Kontakt:
Phone: 0049 34197
Phone (ext.): 16256
E-Mail: anett.schmiedeknecht@zks.uni-leipzig.de
» Kontaktdaten anzeigen

Studienlocations
(3 von 15)

Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie
Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Balint Tamaskovics, Dr.
» Ansprechpartner anzeigen
Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und
Potsdam
(Brandenburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Georg Maschmeyer, Prof. Dr.
» Ansprechpartner anzeigen
Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie
Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marc Münter, Prof. Dr.
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

This trial evaluates the addition of pembrolizumab to standard postoperative adjuvant

radiochemotherapy in the treatment of patients with locally advanced intermediate and high

risk head and neck squamous cell carcinoma (HNSCC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Macroscopically complete resection of newly diagnosed (not recurrent, not secondary

primary) advanced squamous-cell carcinoma arising in the oral cavity, oropharynx,

larynx, or hypopharynx

2. Advanced stage III, IVA/B HNSCC according to the TNM classification version 7th

edition (Note! The 8th edition will not be used, please adhere to the national cancer

institute guidelines)

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; performance

status allows adjuvant chemo radiation with cisplatin.

4. Had either intermediate or high-risk characteristics, i.e. any or all of the

following:

- histologic evidence of invasion of two or more regional lymph nodes

- extracapsular extension of nodal disease,

- microscopically involved mucosal margins of resection (R1) or margins of

resection < 5mm (R0)

5. Had pathological histologic assessment of p16 (only oropharyngeal carcinoma)

6. Be > 18 years of age

7. Written informed consent

8. Demonstrate adequate organ function

9. Female subject of childbearing potential should have a negative pregnancy test within

3 days prior to receiving the first dose of study medication.

10. Female subjects of childbearing potential must be willing to use an adequate method of

contraception, for the course of the study through 120 days after the last dose of

study medication.

11. Reproductive male subjects must agree to use an adequate method of contraception,

starting with the first dose of study therapy through 120 days after the last dose of

study therapy

Exclusion Criteria:

1. Concurrent participation in any other interventional clinical trial or participation

in any other interventional trial within one month before enrolment into this trial.

2. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other

form of immunosuppressive therapy within 7 days before enrolment into this trial.

3. Known history of active TB (Bacillus Tuberculosis)

4. Hypersensitivity to Pembrolizumab or comparable medicinal products or any of its

excipients.

5. Prior anti-cancer monoclonal antibody (mAb) therapy within one month before enrolment

into this trial or who has not recovered (i.e., ≤ Grade 1 (NCI CTCAE Grade) at

baseline) from adverse events due to agents administered more than one month earlier.

6. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within one

month before enrolment into this trial or who has not recovered (i.e., ≤ grade 1 (NCI

CTCAE Grade) at baseline) from adverse events due to a previously administered agent.

1. Note: Subjects with ≤ Grade 2 (NCI CTCAE Grade) neuropathy are an exception to

this criterion and may qualify for the study.

2. Note: If subject received major surgery, they must have recovered adequately from

the toxicity and/or complications from the intervention prior to starting

therapy.

7. 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.

8. Active autoimmune disease that has required systemic treatment in the past 2 years

prior to enrolment (i.e. with use of disease modifying agents, corticosteroids or

immunosuppressive drugs). Replacement therapy (e g., thyroxine, insulin, or

physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,

etc.) is not considered a form of systemic treatment.

9. Evidence of interstitial lung disease or history of (non-infectious) pneumonitis that

required steroids within the last 6 months before enrolment into this trial, or

current pneumonitis.

10. Active infection requiring systemic therapy.

11. Suspected lack of compliance

12. Is pregnant or breastfeeding, or expecting to conceive or father children within the

projected duration of the trial, starting with the baseline visit through 120 days

after the last dose of trial treatment.

13. HIV, HBV or HCV infection

14. Application of a live vaccine within one month of enrolment.

15. Hypersensitivity to cisplatin or any of its excipients

16. Any potential relationship to the investigator/his deputy or to medical staff of the

study team, to the coordinating investigator or is an employee of the study sit

Studien-Rationale

Primary outcome:

1. Event Free Survival (EFS) (Time Frame - 24 months):
time from randomization to the first event (i.e. locoregional or distant recurrence, initiation of a new anti-cancer treatment death from any cause)



Secondary outcome:

1. Overall survival (OS) (Time Frame - 24 months):
time from randomization to death from any cause

Studien-Arme

  • Experimental: Pembrolizumab + aRCH
    Application of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH)
  • Active Comparator: aRCH
    adjuvant radio-chemotherapy (aRCH)

Geprüfte Regime

  • Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]:
    intravenous application, 12 months, in 3-week cycle (q3w) 200 mg
  • adjuvant radiochemotherapy:
    adjuvant radiochemotherapy with cisplatin

Quelle: ClinicalTrials.gov


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