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:
06.09.2023
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 InvestigatorUniversity 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 16)
Berlin Germany Bielefeld Nordrhein-Westfalen Bonn Düsseldorf Erfurt Thüringen Essen Hamburg Jena Leipzig Sachsen Lübeck Schleswig-Holstein Mannheim Baden-Württemberg Potsdam Brandenburg Regensburg Bayern Stuttgart Würzburg
Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK Berlin (Berlin) GermanyRekrutierend » Google-Maps Ansprechpartner: Marcus Beck, Dr. » Ansprechpartner anzeigen Charité - Universitätsmedizin, CVK und CCM, Klinik für Hals-Nasen-Ohrenheilkunde Berlin (Berlin) GermanyRekrutierend » Google-Maps Ansprechpartner: Steffen Dommerich, Dr. » Ansprechpartner anzeigen Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin Bielefeld (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Ansprechpartner: Martin Görner, Dr. » Ansprechpartner anzeigen Universitätsklinikum Bonn; Med. Klinik III / ZIM, Hämatologie/Onkologie Bonn (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Ansprechpartner: Peter Brossart, Prof. Dr. » Ansprechpartner anzeigen Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie Düsseldorf (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Ansprechpartner: Balint Tamaskovics, Dr. » Ansprechpartner anzeigen Helios Klinikum Erfurt GmbH, Klinik für Hals-Nasen-Ohrenheilkunde Erfurt (Thüringen) GermanyRekrutierend » Google-Maps Ansprechpartner: Holger Kaftan, Prof. Dr. » Ansprechpartner anzeigen Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie Essen (Nordrhein-Westfalen) GermanyRekrutierend » Google-Maps Ansprechpartner: Christoph Gauler, Dr. » Ansprechpartner anzeigen Kath. Marienkrankenhaus gGmbH, Zentrum für Innere Medizin Hämatologie/Onkologie Hamburg (Hamburg) GermanyRekrutierend » Google-Maps Ansprechpartner: Gunnar Hapke, Dr. » Ansprechpartner anzeigen Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde Jena (Thüringen) GermanyRekrutierend » Google-Maps Ansprechpartner: Orlando Guntinas-Lichius, Prof. Dr. » Ansprechpartner anzeigen Department of Head Medicine and Oral Health, University of Leipzig 04103 Leipzig (Sachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Andreas Dietz, Prof. Dr. » Ansprechpartner anzeigen UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck Lübeck (Schleswig-Holstein) GermanyRekrutierend » Google-Maps Ansprechpartner: Ursula Schröder, Dr. » Ansprechpartner anzeigen Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik Mannheim (Baden-Württemberg) GermanyRekrutierend » Google-Maps Ansprechpartner: Nicole Rotter, Prof. Dr. » Ansprechpartner anzeigen Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und Potsdam (Brandenburg) GermanyRekrutierend » Google-Maps Ansprechpartner: Matthias Paland, Dr. » Ansprechpartner anzeigen Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie Regensburg (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Matthias Hautmann, Dr. » Ansprechpartner anzeigen Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie Stuttgart (Baden-Württemberg) GermanyRekrutierend » Google-Maps Ansprechpartner: Marc Münter, Prof. Dr. » Ansprechpartner anzeigen Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie Würzburg (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Victor Lewitzki, Dr. » Ansprechpartner anzeigen Alle anzeigen
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).
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 therapyExclusion 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
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
Experimental: Pembrolizumab + aRCHApplication of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH) Active Comparator: aRCHadjuvant radio-chemotherapy (aRCH)
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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"Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma"
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