Postoperative aRCH With Cisplatin Versus aRCH With Cisplatin and Pembrolizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03480672|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : May 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HNSCC||Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] Other: adjuvant radiochemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Adjuvant Radiochemotherapy (aRCH) With Cisplatin (C) Versus aRCH With C and Pembrolizumab (P) in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC); Multicenter Randomized Phase II Study Within the German Interdisciplinary Study Group of German Cancer Society (IAG KHT); Pembro-Adjuvant-highRisk|
|Actual Study Start Date :||August 6, 2018|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||August 2024|
Experimental: Pembrolizumab + aRCH
Application of pembrolizumab, i.v., in 3-week cycle (q3w) 200 mg, in combination with standard treatment (adjuvant radio-chemotherapy aRCH)
Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
intravenous application, 12 months, in 3-week cycle (q3w) 200 mg
Other: adjuvant radiochemotherapy
adjuvant radiochemotherapy with cisplatin
Active Comparator: aRCH
adjuvant radio-chemotherapy (aRCH)
Other: adjuvant radiochemotherapy
adjuvant radiochemotherapy with cisplatin
- 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)
- Overall survival (OS) [ Time Frame: 24 months ]time from randomization to death from any cause
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Macroscopically complete resection of newly diagnosed (not recurrent, not secondary primary) advanced squamous-cell carcinoma arising in the oral cavity, oropharynx, larynx, or hypopharynx
- 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)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; performance status allows adjuvant chemo radiation with cisplatin.
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)
- Had pathological histologic assessment of p16 (only oropharyngeal carcinoma)
- Be > 18 years of age
- Written informed consent
- Demonstrate adequate organ function
- Female subject of childbearing potential should have a negative pregnancy test within 3 days prior to receiving the first dose of study medication.
- 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.
- 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
- Concurrent participation in any other interventional clinical trial or participation in any other interventional trial within one month before enrolment into this trial.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrolment into this trial.
- Known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to Pembrolizumab or comparable medicinal products or any of its excipients.
- 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.
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.
- Note: Subjects with ≤ Grade 2 (NCI CTCAE Grade) neuropathy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- 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.
- 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.
- 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.
- Active infection requiring systemic therapy.
- Suspected lack of compliance
- 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.
- HIV, HBV or HCV infection
- Application of a live vaccine within one month of enrolment.
- Hypersensitivity to cisplatin or any of its excipients
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480672
|Contact: Andreas Dietz, Prof. Dr.||0049 34197 ext firstname.lastname@example.org|
|Contact: Anett Schmiedeknecht, Dr.||0049 34197 ext email@example.com|
|Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK||Recruiting|
|Contact: Marcus Beck, Dr.|
|Charité - Universitätsmedizin, CVK und CCM, Klinik für Hals-Nasen-Ohrenheilkunde||Recruiting|
|Contact: Steffen Dommerich, Dr.|
|Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin||Recruiting|
|Contact: Martin Görner, Dr.|
|Universitätsklinikum Bonn; Med. Klinik III / ZIM, Hämatologie/Onkologie||Recruiting|
|Contact: Peter Brossart, Prof. Dr.|
|Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie||Recruiting|
|Contact: Balint Tamaskovics, Dr.|
|Helios Klinikum Erfurt GmbH, Klinik für Hals-Nasen-Ohrenheilkunde||Recruiting|
|Contact: Holger Kaftan, Prof. Dr.|
|Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie||Recruiting|
|Contact: Christoph Gauler, Dr.|
|Kath. Marienkrankenhaus gGmbH, Zentrum für Innere Medizin Hämatologie/Onkologie||Recruiting|
|Contact: Gunnar Hapke, Dr.|
|Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde||Recruiting|
|Contact: Orlando Guntinas-Lichius, Prof. Dr.|
|Department of Head Medicine and Oral Health, University of Leipzig||Recruiting|
|Leipzig, Germany, 04103|
|Contact: Andreas Dietz, Prof. Dr.|
|UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck||Recruiting|
|Contact: Ursula Schröder, Dr.|
|Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik||Recruiting|
|Contact: Nicole Rotter, Prof. Dr.|
|Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und||Recruiting|
|Contact: Matthias Paland, Dr.|
|Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie||Recruiting|
|Contact: Matthias Hautmann, Dr.|
|Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie||Recruiting|
|Contact: Marc Münter, Prof. Dr.|
|Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie||Recruiting|
|Contact: Victor Lewitzki, Dr.|
|Principal Investigator:||Andreas Dietz, Prof. Dr.||University Leipzig|
|Responsible Party:||Andreas Dietz, Prof. Dr. med., University of Leipzig|
|Other Study ID Numbers:||
|First Posted:||March 29, 2018 Key Record Dates|
|Last Update Posted:||May 24, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action